Adolescent, Child, Child, Preschool
Conditions
Keywords
COHORT A :, Gait, Activity, Actigraphy, COHORT B:, Sleep
Brief summary
COHORT A: To study whether a digital health tool called Actigraph can be used to collect information on gait and physical activity in healthy children aged 3-17. The study will be conducted at the Pfizer Innovation Research Laboratory (PfIRe Lab) in Cambridge MA. In the lab at the first visit, we will ask participants to do activities such as walking on different surfaces as well as to roll a dice and move between different activity stations. Children will wear 2 Actigraph devices, one as a watch and one as a belt. They will then go home and do usual daily activities while answering a brief daily activity diary for approximately 2 weeks. The conclusion of the study will be over the telephone and include questions on the comfort and wearability of the device. The analysis of gait and physical activity as well as adherence and wearability will be looked across three different age groups 3-5, 6-11, and 12-17. COHORT B: Cohort B of the study aims to evaluate the feasibility of the Panoramic Bracelet and associated algorithms such as SleepPy and GaitPy compared to the GENEActiv device and to evaluate the comfort and wearability of the Panoramic Bracelet. The results of this study will enable the use of novel devices in future clinical trials measuring scratch and sleep. . In the lab at the first visit, we will ask participants to do activities such as walking on different surfaces as well as to roll a dice and move between different activity stations. They will then go home and do usual daily activities while wearing both devices in the same wrist at different times stipulated in the protocol, answering a brief daily activity and sleep diary for approximately 2 weeks. Cohort B includes questions on the comfort and wearability of the Panoramic device on Day 7 approximately. The conclusion of the study will be over the telephone.The analysis will be looked across three different age groups 3-5, 6-11, and 12-17
Interventions
DEVICECOHORT A: Actigraph
The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring.
DEVICEPanoramic Bracelet and GENEActiv
Panoramic Bracelet: The Panoramic Digital Health Bracelet is a wearable inertial measurement unit intended for use by researchers and healthcare professionals for high frequency or continuous collection of physical data in home and professional healthcare settings during research studies. It includes a 3 axis accelerometer and gyroscope, as well as magnetometer, pressure, and temperature sensors. The bracelet has no interface or screen for participants to interact with. GENEActiv: The GENEActiv device is a wearable inertial measurement unit designed for public health research and clinical trials. The device is a circular unit with attachable wrist-bands, and has no interface or screen for participants to interact with. The GENEActiv device is FDA 510(k) exempt. The device records acceleration data and can collect data remotely for up to 1 month.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Ambulatory * No significant health problems that would impair the completion of the physical activity tasks, does not carry any diagnosis of developmental delay and/or significant co-morbid medical conditions as determined by a medically qualified individual during medical history review
Exclusion criteria
* Participation in other studies involving digital devices within 1 week and/or treatment with an investigational drug (Phases 1-4) within 30 days or 5 half-lives before the current study begins and/or during study participation. * Participants with implanted medical devices. * Minor participants who reach the age of majority during the study, as recognized under local law. * Any medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * Participants with known allergies to components as specified by device manufacturer if applicable (eg, plastic, stainless steel and silicone).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort A: Number of Days to Complete Enrollment | Up to approximately 8 months | Number of days to complete enrollment corresponded to the total number of days it took to enroll all study participants within the age groups of 3-5 years, 6-11 years and 12-17 years. |
| Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Up to 20 minutes on Day 1 | Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference). |
| Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Up to 20 minutes on Day 1 | Swing time was defined as the time during which the foot was not in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference). |
| Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Up to 20 minutes of Day 1 | Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference). |
| Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Up to 20 minutes on Day 1 | Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants had a single in-laboratory visit on Day 1 during which they performed gait monitoring procedures. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference). |
| Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Up to 20 minutes on Day 1 | Cadence referred to the number of steps taken per minute during gait cycle. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference). |
| Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Up to 20 minutes on Day 1 | Stride duration refers to the duration between successive heel contacts of the same foot. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference). |
| Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | Up to 20 minutes on Day 1 | Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference). |
| Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | Up to 20 minutes on Day 1 | Single support time referred to the time when only one limb was in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference). |
| Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | Up to 20 minutes on Day 1 | Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had a single in-lab visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference). |
| Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | Up to 20 minutes on Day 1 | Swing duration was defined as the time during which the foot was not in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference). |
| Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | Up to 20 minutes on Day 1 | Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference). |
| Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | Up to 20 minutes on Day 1 | Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants had a single in-lab visit during which they performed gait monitoring procedures. For in-lab simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference). |
| Cohort B: Number of Wake Bouts During the At-Home Period | From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv | Number of wake bouts for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window. |
| Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | Up to 20 minutes on Day 1 | Cadence referred to the number of steps taken per minute during gait cycle. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference). |
| Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | Up to 20 minutes on Day 1 | Gait speed was the time taken to walk a specified distance. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference). |
| Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities | Up to 20 minutes on Day 1 | Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference). |
| Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | Up to 20 minutes on Day 1 | Stride duration refers to the duration between successive heel contacts of the same foot. Participants had a single in-lab visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference). |
| Cohort B: Total Sleep Time During the At-Home Period | From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv | Total sleep time for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's total sleep opportunity (TSO) window and computing sleep metrics within that window. |
| Cohort B: Percentage of Time Asleep During the At-Home Period | From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv | The percentage of time asleep for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window. |
| Cohort B: Sleep Onset Latency During the At-Home Period | From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv | Sleep onset latency which is time to transition from full wakefulness to sleep, for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window. |
| Cohort B: Wake After Sleep Onset During the At-Home Period | From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv | Wake after sleep onset is time for which participants were awake after having initially fallen asleep, for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window. |
| Cohort B: Total Scratch Duration During the At-Home Period | From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv | Total scratch duration for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window. |
| Cohort B: Total Scratch Episodes During the At-Home Period | From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv | Total scratch episodes for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window. |
| Cohort B: Number of Available Minutes During the At-Home Period | From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv | Available minutes represented any recorded accelerometer data per day per device in minutes. Number of available minutes for GENEActiv and Panoramic Bracelet was derived by the in-house built Sci-kit Digital Health (SKDH) package. |
| Cohort B: Number of Minutes of Wear During the At-Home Period | From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv | Number of minutes of wear include the total number of minutes the device is worn including sleep time and awake time. The wear time parameter (number of minutes of wear) for GENEActiv and Panoramic Bracelet was derived by the in-house built SKDH package. |
| Cohort B: Number of Wear Minutes While Awake During the At-Home Period | From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv | The wear time parameter (number of wear minutes while awake) for GENEActiv and Panoramic Bracelet was derived by the in-house built SKDH package. |
| Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Day 7 | Wearability/comfort questionnaire included a total of 10 items for which the participants (12 to 17 years) or their caregivers (participants aged 3 to 11 years) were required to provide a response on a scale of 0 to 4, where 0 = strongly disagree, and 4 = strongly agree, higher scores indicated more comfort, except for questions 5 (The device changes the way I move) and 6 (The device changes the way I behave) , where 0 = strongly agree and 4 = strongly disagree, higher scores indicate more comfort. Number of participants according to response to each item of the wearability/comfort questionnaire is reported. |
| Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Up to 20 minutes on Day 1 | Gait speed was the time taken to walk a specified distance. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference). |
| Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Up to 20 minutes on Day 1 | Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference). |
| Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Up to 20 minutes on Day 1 | Single support time referred to the time when only one limb was in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometery data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Up to 20 minutes on Day 1 | Number of participants who were able to perform each of the 7 tasks (i.e., walking at natural, slow and fast speeds, tile and carpet walks, 2 sessions of in-lab simulated activities) is reported in this outcome measure. |
| Cohort A: Percentage of Tasks Completed (From a Total of 7 Tasks) | Up to 20 minutes on Day 1 | Percentage of tasks completed from a total of 7 tasks (i.e., walking at natural, slow and fast speeds, tile and carpet walks, 2 sessions of in-lab simulated activities) is reported in this outcome measure. |
| Cohort A: Number of Hours Per Day Wearing the Lumbar and Wrist Devices | From Day 1 to Day 15 (+ 3 days) | — |
| Cohort A: Number of Days With More Than 10 Hours of Wear Time for Lumbar Device | From Day 1 to Day 15 (+ 3 days) | — |
| Cohort A: Number of Days With More Than 18 Hours of Wear Time for Wrist Device | From Day 1 to Day 15 (+ 3 days) | — |
| Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | Day 1 | Wearability/comfort questionnaire included a total of 10 items for which the participants (12 to 17 years) or their caregivers (participants aged 3 to 11 years) were required to provide a response on a scale of 0 to 4, where 0 = strongly disagree, and 4 = strongly agree, higher scores indicate more comfort except for questions 5 (The device changes the way I move) and 6 (The device changes the way I behave) , where 0 = strongly agree and 4 = strongly disagree, higher scores indicate more comfort. Number of participants according to response to each item of the wearability/comfort questionnaire is reported. |
| Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | Day 15 (+ 3 days) | Wearability/comfort questionnaire included a total of 10 items for which the participants (12 to 17 years) or their caregivers (participants aged 3 to 11 years) were required to provide a response on a scale of 0 to 4, where 0 = strongly disagree, and 4 = strongly agree, higher scores indicate more comfort except for questions 5 (The device changes the way I move) and 6 (The device changes the way I behave) , where 0 = strongly agree and 4 = strongly disagree, higher scores indicate more comfort. Number of participants according to response to each item of the wearability/comfort questionnaire is reported. |
| Cohort A: Double Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | Up to 20 minutes on Day 1 | Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had a single in-lab visit during which they performed gait monitoring procedures. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect. |
| Cohort A: Single Limb Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | Up to 20 minutes on Day 1 | Single limb support time referred to the time when only one limb was in contact with the ground. Participants had a single in-lab visit during which they performed gait monitoring procedures. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect. |
| Cohort A: Stance Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | Up to 20 minutes on Day 1 | Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect. |
| Cohort A: Swing Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | Up to 20 minutes on Day 1 | Swing time was defined as the time during which the foot was not in contact with the ground. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect. |
| Cohort A: Stride Length Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | Up to 20 minutes on Day 1 | Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. Participants had a single in-lab visit during which they performed gait monitoring procedures. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect. |
| Cohort A: Step Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | Up to 20 minutes on Day 1 | Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect. |
| Cohort A: Cadence Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | Up to 20 minutes on Day 1 | Cadence referred to the number of steps taken per minute during gait cycle. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect. |
| Cohort A: Gait Speed Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | Up to 20 minutes on Day 1 | Gait speed was the time taken to walk a specified distance. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect. |
| Cohort A: Stride Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | Up to 20 minutes on Day 1 | Stride duration refers to the duration between successive heel contacts of the same foot. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect. |
| Cohort B: Number of Hours Per Day Wearing the Panoramic Bracelet Devices at Home | From Day 1 up to Day 7 | — |
| Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Up to 20 minutes on Day 1 | Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics. |
| Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Up to 20 minutes on Day 1 | Single support time referred to the time when only one limb was in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics. |
| Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Up to 20 minutes on Day 1 | Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics. |
| Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Up to 20 minutes on Day 1 | Swing time was defined as the time during which the foot was not in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics. |
| Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Up to 20 minutes on Day 1 | Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics. |
| Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Up to 20 minutes on Day 1 | Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics. |
| Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Up to 20 minutes on Day 1 | Cadence referred to the number of steps taken per minute during gait cycle. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics. |
| Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | Up to 20 minutes on Day 1 | Gait speed was the time taken to walk a specified distance. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics. |
| Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Up to 20 minutes on Day 1 | Stride duration refers to the duration between successive heel contacts of the same foot. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics. |
| Cohort A: Number of Participants Enrolled Over Time | Up to approximately 8 months | Number of participants enrolled at specified month intervals in the study is reported in this outcome measure. |
Countries
United States
Participant flow
Pre-assignment details
In this observational study, healthy pediatric participants (aged 3-17) were enrolled in 2 cohorts: Cohort A and B. A total of 87 participants (Cohort A: 40 and Cohort B: 47) were screened and enrolled in the study. No intervention was administered during this study.
Participants by arm
| Arm | Count |
|---|---|
| Cohort A: Participants Aged 3-5 Years Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1. | 13 |
| Cohort A: Participants Aged 6-11 Years Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1. | 14 |
| Cohort A: Participants Aged 12-17 Years Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1. | 13 |
| Cohort B: Participants Aged 3-5 Years Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1. | 13 |
| Cohort B: Participants Aged 6-11 Years Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1. | 17 |
| Cohort B: Participants Aged 12-17 Years Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1. | 17 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort A: Participants Aged 3-5 Years | Cohort A: Participants Aged 6-11 Years | Cohort A: Participants Aged 12-17 Years | Total | Cohort B: Participants Aged 3-5 Years | Cohort B: Participants Aged 6-11 Years | Cohort B: Participants Aged 12-17 Years |
|---|---|---|---|---|---|---|---|
| Age, Continuous Cohort A | 4.38 Years STANDARD_DEVIATION 0.65 | 9.00 Years STANDARD_DEVIATION 1.8 | 14.77 Years STANDARD_DEVIATION 1.59 | 9.38 Years STANDARD_DEVIATION 4.48 | — | — | — |
| Age, Continuous Cohort B | — | — | — | 9.23 Years STANDARD_DEVIATION 4.26 | 4.00 Years STANDARD_DEVIATION 0.82 | 8.53 Years STANDARD_DEVIATION 1.62 | 13.94 Years STANDARD_DEVIATION 1.68 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 2 Participants | 9 Participants | 0 Participants | 4 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 11 Participants | 11 Participants | 76 Participants | 13 Participants | 13 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 5 Participants | 15 Participants | 1 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 7 Participants | 3 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 10 Participants | 8 Participants | 62 Participants | 8 Participants | 12 Participants | 16 Participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 9 Participants | 49 Participants | 8 Participants | 8 Participants | 11 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 4 Participants | 38 Participants | 5 Participants | 9 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 14 | 0 / 13 | 0 / 13 | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 4 / 13 | 3 / 14 | 3 / 13 | 2 / 13 | 4 / 17 | 3 / 17 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 | 0 / 13 | 0 / 13 | 0 / 17 | 0 / 17 |
Outcome results
Primary
Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
Cadence referred to the number of steps taken per minute during gait cycle. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 126.97 Steps per minute | Standard Deviation 7.487 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 128.71 Steps per minute | Standard Deviation 5.515 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 130.96 Steps per minute | Standard Deviation 7.346 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 129.90 Steps per minute | Standard Deviation 6.846 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 122.49 Steps per minute | Standard Deviation 9.919 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 118.54 Steps per minute | Standard Deviation 11.395 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 120.51 Steps per minute | Standard Deviation 8.758 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 122.32 Steps per minute | Standard Deviation 11.001 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 109.63 Steps per minute | Standard Deviation 6.715 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 108.15 Steps per minute | Standard Deviation 6.842 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 110.84 Steps per minute | Standard Deviation 7.109 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 109.47 Steps per minute | Standard Deviation 7.972 |
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.06, 0.81]
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [0.37, 0.94]
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [0.73, 0.99]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [0.06, 0.85]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [0.45, 0.93]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [0.63, 0.99]
Primary
Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
Cadence referred to the number of steps taken per minute during gait cycle. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 139.59 Steps per minute | Standard Deviation 17.74 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 94.57 Steps per minute | Standard Deviation 17.679 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 139.50 Steps per minute | Standard Deviation 10.993 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 147.26 Steps per minute | Standard Deviation 19.313 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 123.07 Steps per minute | Standard Deviation 17.515 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 91.77 Steps per minute | Standard Deviation 16.656 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 124.09 Steps per minute | Standard Deviation 20.093 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 120.57 Steps per minute | Standard Deviation 17.555 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 98.12 Steps per minute | Standard Deviation 14.187 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 130.42 Steps per minute | Standard Deviation 16.612 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 118.17 Steps per minute | Standard Deviation 13.763 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 117.97 Steps per minute | Standard Deviation 14.652 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 120.04 Steps per minute | Standard Deviation 13.073 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 134.16 Steps per minute | Standard Deviation 17.301 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 137.06 Steps per minute | Standard Deviation 17.574 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 81.48 Steps per minute | Standard Deviation 16.704 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 76.61 Steps per minute | Standard Deviation 17.346 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 78.38 Steps per minute | Standard Deviation 18.1 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 107.97 Steps per minute | Standard Deviation 7.556 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 106.00 Steps per minute | Standard Deviation 7.971 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 82.59 Steps per minute | Standard Deviation 11.866 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 104.23 Steps per minute | Standard Deviation 9.496 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 82.55 Steps per minute | Standard Deviation 12.486 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 113.16 Steps per minute | Standard Deviation 9.725 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 118.24 Steps per minute | Standard Deviation 8.667 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 81.53 Steps per minute | Standard Deviation 11.926 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 122.30 Steps per minute | Standard Deviation 9.326 |
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.74, 0.99]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.92, 0.99]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.66, 0.97]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [0.92, 0.99]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [0.8, 0.99]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [-0.19, 0.99]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.89, 0.99]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.91, 0.99]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.5, 0.97]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.64, 0.42]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [0.64, 0.97]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [0, 0.85]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [0.49, 0.94]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [0.68, 0.99]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [-0.11, 0.98]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.17, 0.53]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.65, 0.97]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.04, 0.87]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [-0.09, 0.97]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [0.34, 0.98]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [0.92, 0.99]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [0.63, 0.98]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [0.76, 0.98]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [0.96, 1]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.61, 0.98]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.79, 0.98]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.96, 1]
Primary
Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.22 Seconds | Standard Deviation 0.029 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.25 Seconds | Standard Deviation 0.013 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.21 Seconds | Standard Deviation 0.034 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.24 Seconds | Standard Deviation 0.012 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.27 Seconds | Standard Deviation 0.02 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.21 Seconds | Standard Deviation 0.061 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.19 Seconds | Standard Deviation 0.19 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.26 Seconds | Standard Deviation 0.022 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.30 Seconds | Standard Deviation 0.023 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.30 Seconds | Standard Deviation 0.022 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.21 Seconds | Standard Deviation 0.039 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.22 Seconds | Standard Deviation 0.046 |
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.2, 0.4]
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.22, 0.5]
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.05, 0.64]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [-0.18, 0.39]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [-0.07, 0.3]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [-0.04, 0.57]
Primary
Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).
Time frame: Up to 20 minutes on Day 1
Population: Full Analysis Set (FAS) included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 0.23 Seconds | Standard Deviation 0.02 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.36 Seconds | Standard Deviation 0.15 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.16 Seconds | Standard Deviation 0.027 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.18 Seconds | Standard Deviation 0.048 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 0.26 Seconds | Standard Deviation 0.031 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.45 Seconds | Standard Deviation 0.155 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.22 Seconds | Standard Deviation 0.081 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.28 Seconds | Standard Deviation 0.096 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 0.29 Seconds | Standard Deviation 0.024 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.20 Seconds | Standard Deviation 0.057 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 0.27 Seconds | Standard Deviation 0.029 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.26 Seconds | Standard Deviation 0.053 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.17 Seconds | Standard Deviation 0.033 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 0.24 Seconds | Standard Deviation 0.028 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.13 Seconds | Standard Deviation 0.031 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 0.32 Seconds | Standard Deviation 0.039 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.60 Seconds | Standard Deviation 0.192 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.41 Seconds | Standard Deviation 0.144 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.21 Seconds | Standard Deviation 0.048 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 0.30 Seconds | Standard Deviation 0.022 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 0.32 Seconds | Standard Deviation 0.034 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.31 Seconds | Standard Deviation 0.049 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.38 Seconds | Standard Deviation 0.126 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.24 Seconds | Standard Deviation 0.042 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 0.27 Seconds | Standard Deviation 0.02 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.53 Seconds | Standard Deviation 0.139 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.14 Seconds | Standard Deviation 0.039 |
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.02, 0.84]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.35, 0.91]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.14, 0.87]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [-0.11, 0.82]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [-0.01, 0.52]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [-0.04, 0.59]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.17, 0.88]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.04, 0.71]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.04, 0.7]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.18, 0.66]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.21, 0.83]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.19, 0.72]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [-0.07, 0.46]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [-0.01, 0.44]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [-0.02, 0.35]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.08, 0.59]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.05, 0.7]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.03, 0.53]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [-0.25, 0.34]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [-0.13, 0.27]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [-0.21, 0.21]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [-0.5, 0.44]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [-0.31, 0.5]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [-0.62, 0.29]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.02, 0.69]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.08, 0.59]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.07, 0.52]
Primary
Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
Gait speed was the time taken to walk a specified distance. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.72 Meters per second | Standard Deviation 0.111 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.91 Meters per second | Standard Deviation 0.084 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.73 Meters per second | Standard Deviation 0.158 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.92 Meters per second | Standard Deviation 0.097 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 1.03 Meters per second | Standard Deviation 0.09 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.80 Meters per second | Standard Deviation 0.21 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.85 Meters per second | Standard Deviation 0.161 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.98 Meters per second | Standard Deviation 0.085 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.96 Meters per second | Standard Deviation 0.13 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.95 Meters per second | Standard Deviation 0.104 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.98 Meters per second | Standard Deviation 0.106 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.97 Meters per second | Standard Deviation 0.109 |
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.16, 0.26]
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.21, 0.49]
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.14, 0.8]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [-0.22, 0.35]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [-0.35, 0.26]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [-0.32, 0.71]
Primary
Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
Gait speed was the time taken to walk a specified distance. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 1.03 Meters per second | Standard Deviation 0.231 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.49 Meters per second | Standard Deviation 0.159 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 1.00 Meters per second | Standard Deviation 0.218 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 1.32 Meters per second | Standard Deviation 0.268 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 0.83 Meters per second | Standard Deviation 0.192 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.57 Meters per second | Standard Deviation 0.164 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.81 Meters per second | Standard Deviation 0.213 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.93 Meters per second | Standard Deviation 0.234 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 0.56 Meters per second | Standard Deviation 0.15 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 1.49 Meters per second | Standard Deviation 0.252 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 1.00 Meters per second | Standard Deviation 0.142 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 1.13 Meters per second | Standard Deviation 0.127 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 1.02 Meters per second | Standard Deviation 0.119 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 1.22 Meters per second | Standard Deviation 0.129 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 1.36 Meters per second | Standard Deviation 0.247 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 0.58 Meters per second | Standard Deviation 0.173 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.54 Meters per second | Standard Deviation 0.151 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.45 Meters per second | Standard Deviation 0.153 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 1.10 Meters per second | Standard Deviation 0.171 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 1.04 Meters per second | Standard Deviation 0.174 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 0.64 Meters per second | Standard Deviation 0.173 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 1.21 Meters per second | Standard Deviation 0.177 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.66 Meters per second | Standard Deviation 0.196 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 1.56 Meters per second | Standard Deviation 0.161 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 1.30 Meters per second | Standard Deviation 0.115 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.75 Meters per second | Standard Deviation 0.204 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 1.43 Meters per second | Standard Deviation 0.139 |
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [-0.16, 0.95]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [-0.1, 0.91]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [-0.05, 0.92]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [0.33, 0.91]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [0.65, 0.96]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [-0.16, 0.98]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.36, 0.93]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.08, 0.94]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.04, 0.96]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.17, 0.84]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [-0.15, 0.89]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.16, 0.77]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.07, 0.74]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [0.58, 0.95]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [-0.13, 0.85]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.1, 0.87]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.1, 0.88]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.05, 0.85]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [0.54, 0.95]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [-0.27, 0.72]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.19, 0.79]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [-0.18, 0.96]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [0.09, 0.92]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [-0.19, 0.69]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [0.81, 0.98]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.42, 0.95]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.09, 0.98]
Primary
Cohort A: Number of Days to Complete Enrollment
Number of days to complete enrollment corresponded to the total number of days it took to enroll all study participants within the age groups of 3-5 years, 6-11 years and 12-17 years.
Time frame: Up to approximately 8 months
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Days to Complete Enrollment | 232 Days |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Days to Complete Enrollment | 101 Days |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Days to Complete Enrollment | 77 Days |
Primary
Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
Single support time referred to the time when only one limb was in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.37 Seconds | Standard Deviation 0.024 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.34 Seconds | Standard Deviation 0.017 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.36 Seconds | Standard Deviation 0.015 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.34 Seconds | Standard Deviation 0.02 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.36 Seconds | Standard Deviation 0.032 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.41 Seconds | Standard Deviation 0.038 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.41 Seconds | Standard Deviation 0.028 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.36 Seconds | Standard Deviation 0.031 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.40 Seconds | Standard Deviation 0.024 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.40 Seconds | Standard Deviation 0.022 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.44 Seconds | Standard Deviation 0.017 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.45 Seconds | Standard Deviation 0.021 |
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.16, 0.51]
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.04, 0.86]
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.03, 0.74]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [-0.15, 0.73]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [-0.04, 0.8]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [-0.03, 0.73]
Primary
Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
Single support time referred to the time when only one limb was in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometery data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 0.31 Seconds | Standard Deviation 0.036 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.48 Seconds | Standard Deviation 0.062 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.36 Seconds | Standard Deviation 0.027 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.30 Seconds | Standard Deviation 0.031 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 0.36 Seconds | Standard Deviation 0.054 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.43 Seconds | Standard Deviation 0.058 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.39 Seconds | Standard Deviation 0.045 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.36 Seconds | Standard Deviation 0.034 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 0.47 Seconds | Standard Deviation 0.08 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.34 Seconds | Standard Deviation 0.039 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 0.38 Seconds | Standard Deviation 0.05 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.37 Seconds | Standard Deviation 0.037 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.42 Seconds | Standard Deviation 0.042 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 0.34 Seconds | Standard Deviation 0.042 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.39 Seconds | Standard Deviation 0.042 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 0.59 Seconds | Standard Deviation 0.14 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.51 Seconds | Standard Deviation 0.074 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.59 Seconds | Standard Deviation 0.112 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.46 Seconds | Standard Deviation 0.022 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 0.42 Seconds | Standard Deviation 0.028 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 0.58 Seconds | Standard Deviation 0.123 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.40 Seconds | Standard Deviation 0.027 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.55 Seconds | Standard Deviation 0.055 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.38 Seconds | Standard Deviation 0.029 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 0.37 Seconds | Standard Deviation 0.026 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.48 Seconds | Standard Deviation 0.045 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.42 Seconds | Standard Deviation 0.024 |
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.45, 0.93]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.66, 0.96]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.17, 0.94]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [-0.13, 0.97]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [-0.06, 0.93]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [-0.05, 0.82]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.02, 0.95]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.06, 0.93]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.05, 0.83]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.48, 0.56]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [0.82, 0.98]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [0.58, 0.96]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [-0.14, 0.83]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [-0.05, 0.9]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [-0.03, 0.74]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.07, 0.56]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.04, 0.93]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.04, 0.83]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [-0.18, 0.94]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [-0.21, 0.89]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [-0.21, 0.79]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [0.71, 0.97]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [0.62, 0.95]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [0.26, 0.9]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.07, 0.95]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.02, 0.91]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.06, 0.83]
Primary
Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had a single in-lab visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.59 Seconds | Standard Deviation 0.044 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.60 Seconds | Standard Deviation 0.022 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.57 Seconds | Standard Deviation 0.042 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.60 Seconds | Standard Deviation 0.029 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.63 Seconds | Standard Deviation 0.051 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.62 Seconds | Standard Deviation 0.072 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.60 Seconds | Standard Deviation 0.053 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.63 Seconds | Standard Deviation 0.055 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.71 Seconds | Standard Deviation 0.041 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.72 Seconds | Standard Deviation 0.046 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.65 Seconds | Standard Deviation 0.053 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.66 Seconds | Standard Deviation 0.06 |
Comparison: Activity Block 1: Actigraph Lumbar vs APDM95% CI: [-0.31, 0.69]
Comparison: Activity Block 1: Actigraph Lumbar vs APDM95% CI: [0.3, 0.89]
Comparison: Activity Block 1: Actigraph Lumbar vs APDM95% CI: [-0.09, 0.92]
Comparison: Activity Block 2: Actigraph Lumbar vs APDM95% CI: [-0.18, 0.69]
Comparison: Activity Block 2: Actigraph Lumbar vs APDM95% CI: [-0.07, 0.82]
Comparison: Activity Block 2: Actigraph Lumbar vs APDM95% CI: [-0.04, 0.9]
Primary
Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 0.56 Seconds | Standard Deviation 0.063 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.84 Seconds | Standard Deviation 0.205 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.52 Seconds | Standard Deviation 0.05 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.49 Seconds | Standard Deviation 0.07 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 0.63 Seconds | Standard Deviation 0.085 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.88 Seconds | Standard Deviation 0.207 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.60 Seconds | Standard Deviation 0.119 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.64 Seconds | Standard Deviation 0.129 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 0.75 Seconds | Standard Deviation 0.081 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.55 Seconds | Standard Deviation 0.087 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 0.65 Seconds | Standard Deviation 0.072 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.64 Seconds | Standard Deviation 0.082 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.59 Seconds | Standard Deviation 0.07 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 0.58 Seconds | Standard Deviation 0.075 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.50 Seconds | Standard Deviation 0.075 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 0.91 Seconds | Standard Deviation 0.127 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 1.11 Seconds | Standard Deviation 0.265 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 1.00 Seconds | Standard Deviation 0.227 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.66 Seconds | Standard Deviation 0.065 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 0.72 Seconds | Standard Deviation 0.054 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 0.83 Seconds | Standard Deviation 0.166 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.72 Seconds | Standard Deviation 0.062 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.94 Seconds | Standard Deviation 0.181 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.62 Seconds | Standard Deviation 0.057 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 0.65 Seconds | Standard Deviation 0.046 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 1.02 Seconds | Standard Deviation 0.178 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.56 Seconds | Standard Deviation 0.056 |
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.19, 0.72]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [-0.07, 0.46]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [-0.01, 0.44]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.71, 0.97]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.9, 0.99]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.88, 0.99]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [0.58, 0.97]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [-0.02, 0.95]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [-0.04, 0.92]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.36, 0.93]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.08, 0.94]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.04, 0.96]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.18, 0.66]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.21, 0.83]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [-0.02, 0.35]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.08, 0.59]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.05, 0.7]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.03, 0.53]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [-0.15, 0.75]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [-0.21, 0.81]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [-0.23, 0.5]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [-0.12, 0.76]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [0.04, 0.89]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [-0.34, 0.59]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.25, 0.87]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.01, 0.9]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [0, 0.69]
Primary
Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants had a single in-lab visit during which they performed gait monitoring procedures. For in-lab simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.46 Seconds | Standard Deviation 0.022 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.47 Seconds | Standard Deviation 0.019 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.45 Seconds | Standard Deviation 0.021 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.46 Seconds | Standard Deviation 0.024 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.49 Seconds | Standard Deviation 0.04 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.50 Seconds | Standard Deviation 0.048 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.49 Seconds | Standard Deviation 0.038 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.49 Seconds | Standard Deviation 0.045 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.55 Seconds | Standard Deviation 0.034 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.56 Seconds | Standard Deviation 0.036 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.54 Seconds | Standard Deviation 0.035 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.55 Seconds | Standard Deviation 0.039 |
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [0.08, 0.86]
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [0.72, 0.97]
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.15, 0.99]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [0.1, 0.87]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [0.67, 0.96]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [-0.05, 0.99]
Primary
Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants had a single in-laboratory visit on Day 1 during which they performed gait monitoring procedures. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 0.44 Seconds | Standard Deviation 0.061 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.66 Seconds | Standard Deviation 0.137 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.43 Seconds | Standard Deviation 0.035 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.39 Seconds | Standard Deviation 0.048 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 0.50 Seconds | Standard Deviation 0.072 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.65 Seconds | Standard Deviation 0.128 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.50 Seconds | Standard Deviation 0.081 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.49 Seconds | Standard Deviation 0.08 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 0.62 Seconds | Standard Deviation 0.088 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.44 Seconds | Standard Deviation 0.058 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 0.51 Seconds | Standard Deviation 0.061 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.51 Seconds | Standard Deviation 0.058 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.50 Seconds | Standard Deviation 0.055 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 0.45 Seconds | Standard Deviation 0.059 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.44 Seconds | Standard Deviation 0.058 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 0.76 Seconds | Standard Deviation 0.142 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.80 Seconds | Standard Deviation 0.163 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.80 Seconds | Standard Deviation 0.165 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.56 Seconds | Standard Deviation 0.041 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 0.57 Seconds | Standard Deviation 0.046 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 0.74 Seconds | Standard Deviation 0.109 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.56 Seconds | Standard Deviation 0.043 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.74 Seconds | Standard Deviation 0.116 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.50 Seconds | Standard Deviation 0.037 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 0.51 Seconds | Standard Deviation 0.037 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.75 Seconds | Standard Deviation 0.116 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.50 Seconds | Standard Deviation 0.038 |
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.94, 1]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.72, 0.99]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [-0.01, 1]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [0.95, 0.99]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [0.75, 0.99]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [-0.16, 0.99]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.96, 0.99]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.91, 0.99]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.47, 0.99]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.39, 0.45]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.07, 1]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.21, 0.98]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [0.42, 0.93]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [0.48, 0.99]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [-0.2, 0.98]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.07, 0.58]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.8, 0.99]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.12, 0.98]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [0.58, 0.95]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [0.52, 0.97]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [0.94, 0.99]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [0.42, 0.94]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [0.53, 0.96]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [0.94, 0.99]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.73, 0.96]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.77, 0.98]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.97, 1]
Primary
Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
Stride duration refers to the duration between successive heel contacts of the same foot. Participants had a single in-lab visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.95 Seconds | Standard Deviation 0.06 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.94 Seconds | Standard Deviation 0.047 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.92 Seconds | Standard Deviation 0.05 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.93 Seconds | Standard Deviation 0.055 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.99 Seconds | Standard Deviation 0.079 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 1.02 Seconds | Standard Deviation 0.099 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 1.00 Seconds | Standard Deviation 0.076 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.99 Seconds | Standard Deviation 0.088 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 1.09 Seconds | Standard Deviation 0.067 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 1.10 Seconds | Standard Deviation 0.069 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 1.09 Seconds | Standard Deviation 0.07 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 1.10 Seconds | Standard Deviation 0.081 |
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.28, 0.73]
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [0.23, 0.95]
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [0.91, 0.99]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [0.16, 0.88]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [0.55, 0.94]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [0.93, 0.99]
Primary
Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
Stride duration refers to the duration between successive heel contacts of the same foot. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 0.88 Seconds | Standard Deviation 0.132 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 1.31 Seconds | Standard Deviation 0.265 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.87 Seconds | Standard Deviation 0.07 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.78 Seconds | Standard Deviation 0.093 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 0.99 Seconds | Standard Deviation 0.15 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 1.30 Seconds | Standard Deviation 0.258 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.99 Seconds | Standard Deviation 0.163 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.99 Seconds | Standard Deviation 0.162 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 1.22 Seconds | Standard Deviation 0.155 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.89 Seconds | Standard Deviation 0.123 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 1.02 Seconds | Standard Deviation 0.118 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 1.01 Seconds | Standard Deviation 0.118 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 1.01 Seconds | Standard Deviation 0.111 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 0.91 Seconds | Standard Deviation 0.115 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.89 Seconds | Standard Deviation 0.113 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 1.39 Seconds | Standard Deviation 0.21 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 1.61 Seconds | Standard Deviation 0.327 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 1.60 Seconds | Standard Deviation 0.331 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 1.12 Seconds | Standard Deviation 0.084 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 1.13 Seconds | Standard Deviation 0.082 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 1.41 Seconds | Standard Deviation 0.149 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 1.12 Seconds | Standard Deviation 0.091 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 1.49 Seconds | Standard Deviation 0.233 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.99 Seconds | Standard Deviation 0.079 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 1.01 Seconds | Standard Deviation 0.073 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 1.49 Seconds | Standard Deviation 0.226 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.99 Seconds | Standard Deviation 0.076 |
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.95, 1]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.09, 1]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.96, 1]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [0.95, 0.99]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [0.9, 1]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [0.28, 1]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.96, 0.99]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.97, 1]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.94, 1]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.44, 0.39]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [0.53, 0.99]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.06, 1]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [0.3, 0.91]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [0.44, 0.99]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [-0.12, 0.99]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.11, 0.52]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.84, 0.99]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.04, 0.99]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [0.26, 0.9]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [-0.07, 0.8]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [0.15, 0.88]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [0.18, 0.9]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [-0.05, 0.81]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [0.16, 0.88]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.57, 0.94]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.3, 0.89]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.53, 0.93]
Primary
Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.73 Meter | Standard Deviation 0.09 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.86 Meter | Standard Deviation 0.087 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.71 Meter | Standard Deviation 0.134 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.86 Meter | Standard Deviation 0.094 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 1.02 Meter | Standard Deviation 0.096 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.89 Meter | Standard Deviation 0.185 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.93 Meter | Standard Deviation 0.165 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.99 Meter | Standard Deviation 0.097 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 1.05 Meter | Standard Deviation 0.132 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 1.05 Meter | Standard Deviation 0.11 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 1.14 Meter | Standard Deviation 0.084 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 1.12 Meter | Standard Deviation 0.089 |
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.24, 0.31]
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.19, 0.68]
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.17, 0.72]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [-0.22, 0.44]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [-0.18, 0.68]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [-0.18, 0.7]
Primary
Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).
Time frame: Up to 20 minutes of Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 0.88 Meters | Standard Deviation 0.141 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.61 Meters | Standard Deviation 0.118 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.85 Meters | Standard Deviation 0.144 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 1.02 Meters | Standard Deviation 0.13 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 0.80 Meters | Standard Deviation 0.112 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.71 Meters | Standard Deviation 0.116 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.78 Meters | Standard Deviation 0.126 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.89 Meters | Standard Deviation 0.113 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 0.67 Meters | Standard Deviation 0.122 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 1.32 Meters | Standard Deviation 0.195 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 1.01 Meters | Standard Deviation 0.139 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 1.13 Meters | Standard Deviation 0.127 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 1.02 Meters | Standard Deviation 0.114 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 1.12 Meters | Standard Deviation 0.155 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 1.20 Meters | Standard Deviation 0.196 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 0.75 Meters | Standard Deviation 0.104 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.82 Meters | Standard Deviation 0.136 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.68 Meters | Standard Deviation 0.129 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 1.22 Meters | Standard Deviation 0.118 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Natural Speed | 1.16 Meters | Standard Deviation 0.146 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Slow Speed | 0.90 Meters | Standard Deviation 0.142 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 1.35 Meters | Standard Deviation 0.116 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.94 Meters | Standard Deviation 0.155 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 1.54 Meters | Standard Deviation 0.104 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | ActiGraph: Fast Speed | 1.31 Meters | Standard Deviation 0.109 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 1.08 Meters | Standard Deviation 0.155 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 1.40 Meters | Standard Deviation 0.11 |
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [-0.19, 0.87]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [-0.11, 0.91]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [-0.06, 0.85]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [-0.35, 0.7]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [0.66, 0.96]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [0.02, 0.95]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.08, 0.78]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.08, 0.94]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.05, 0.9]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.15, 0.9]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.15, 0.87]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.04, 0.68]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [0.31, 0.91]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [0.2, 0.91]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [-0.19, 0.91]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.1, 0.9]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.1, 0.92]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.04, 0.81]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [0.26, 0.92]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [0.05, 0.87]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [-0.18, 0.83]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [0.06, 0.89]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [-0.07, 0.86]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [0.38, 0.92]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.01, 0.91]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.08, 0.89]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.11, 0.9]
Primary
Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
Swing duration was defined as the time during which the foot was not in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.33 Seconds | Standard Deviation 0.017 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.35 Seconds | Standard Deviation 0.021 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.33 Seconds | Standard Deviation 0.019 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.36 Seconds | Standard Deviation 0.02 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.40 Seconds | Standard Deviation 0.036 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.36 Seconds | Standard Deviation 0.034 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.36 Seconds | Standard Deviation 0.03 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.40 Seconds | Standard Deviation 0.029 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 1 | 0.44 Seconds | Standard Deviation 0.024 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | APDM: Activity Block 2 | 0.43 Seconds | Standard Deviation 0.019 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 0.40 Seconds | Standard Deviation 0.02 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 0.40 Seconds | Standard Deviation 0.022 |
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.16, 0.52]
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.06, 0.88]
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.06, 0.8]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [-0.21, 0.84]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [-0.02, 0.85]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [-0.06, 0.75]
Primary
Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
Swing time was defined as the time during which the foot was not in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by Actigraph for Walk at Fast Speed | 0.31 Seconds | Standard Deviation 0.03 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by APDM for Walk at Slow Speed | 0.47 Seconds | Standard Deviation 0.063 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by APDM for Walk at Fast Speed | 0.35 Seconds | Standard Deviation 0.025 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by GAITRite for Walk at Fast Speed | 0.30 Seconds | Standard Deviation 0.029 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by Actigraph for Walk at Natural Speed | 0.36 Seconds | Standard Deviation 0.054 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by GAITRite for Walk at Slow Speed | 0.43 Seconds | Standard Deviation 0.058 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by APDM for Walk at Natural Speed | 0.39 Seconds | Standard Deviation 0.047 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by GAITRite for Walk at Natural Speed | 0.35 Seconds | Standard Deviation 0.034 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by Actigraph for Walk at Slow Speed | 0.45 Seconds | Standard Deviation 0.067 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by GAITRite for Walk at Fast Speed | 0.34 Seconds | Standard Deviation 0.039 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by Actigraph for Walk at Natural Speed | 0.38 Seconds | Standard Deviation 0.05 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by GAITRite for Walk at Natural Speed | 0.37 Seconds | Standard Deviation 0.037 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by APDM for Walk at Natural Speed | 0.42 Seconds | Standard Deviation 0.041 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by Actigraph for Walk at Fast Speed | 0.33 Seconds | Standard Deviation 0.043 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by APDM for Walk at Fast Speed | 0.39 Seconds | Standard Deviation 0.042 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by Actigraph for Walk at Slow Speed | 0.53 Seconds | Standard Deviation 0.096 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by GAITRite for Walk at Slow Speed | 0.50 Seconds | Standard Deviation 0.074 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by APDM for Walk at Slow Speed | 0.60 Seconds | Standard Deviation 0.116 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by APDM for Walk at Natural Speed | 0.45 Seconds | Standard Deviation 0.021 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by Actigraph for Walk at Natural Speed | 0.42 Seconds | Standard Deviation 0.028 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by Actigraph for Walk at Slow Speed | 0.56 Seconds | Standard Deviation 0.106 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by GAITRite for Walk at Natural Speed | 0.40 Seconds | Standard Deviation 0.027 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by APDM for Walk at Slow Speed | 0.55 Seconds | Standard Deviation 0.056 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by GAITRite for Walk at Fast Speed | 0.38 Seconds | Standard Deviation 0.028 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by Actigraph for Walk at Fast Speed | 0.37 Seconds | Standard Deviation 0.027 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by GAITRite for Walk at Slow Speed | 0.48 Seconds | Standard Deviation 0.045 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks | Swing Duration Measured by APDM for Walk at Fast Speed | 0.42 Seconds | Standard Deviation 0.025 |
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.53, 0.94]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.66, 0.96]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite95% CI: [0.17, 0.94]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [-0.14, 0.97]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [-0.05, 0.92]
Comparison: Walk at Natural Speed: ActiGraph vs APDM95% CI: [-0.06, 0.81]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.02, 0.95]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.06, 0.93]
Comparison: Walk at Natural Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.05, 0.83]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [-0.32, 0.69]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [0.69, 0.96]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite95% CI: [0.47, 0.95]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [-0.13, 0.8]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [-0.05, 0.88]
Comparison: Walk at Fast Speed: ActiGraph vs APDM95% CI: [-0.03, 0.71]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.08, 0.66]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.05, 0.92]
Comparison: Walk at Fast Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.03, 0.81]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [0.11, 0.86]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [0.29, 0.9]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite95% CI: [-0.2, 0.78]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [0.23, 0.9]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [0, 0.84]
Comparison: Walk at Slow Speed: ActiGraph vs APDM95% CI: [0.03, 0.84]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.2, 0.9]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [0.04, 0.87]
Comparison: Walk at Slow Speed: ActiGraph vs GAITRite vs APDM95% CI: [-0.02, 0.79]
Primary
Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities
Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities | APDM: Activity Block 1 | 109.23 Steps | Standard Deviation 42.54 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 103.00 Steps | Standard Deviation 72.623 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities | ActiGraph Wrist: Activity Block 1 | 187.38 Steps | Standard Deviation 67.463 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities | APDM: Activity Block 2 | 120.77 Steps | Standard Deviation 57.727 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 125.46 Steps | Standard Deviation 71.906 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities | ActiGraph Wrist: Activity Block 2 | 210.92 Steps | Standard Deviation 109.188 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities | ActiGraph Wrist: Activity Block 2 | 275.14 Steps | Standard Deviation 87.96 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities | APDM: Activity Block 1 | 123.00 Steps | Standard Deviation 51.067 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities | APDM: Activity Block 2 | 130.57 Steps | Standard Deviation 56.896 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 172.79 Steps | Standard Deviation 72.707 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 163.43 Steps | Standard Deviation 75.572 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities | ActiGraph Wrist: Activity Block 1 | 242.86 Steps | Standard Deviation 73.539 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 1 | 114.46 Steps | Standard Deviation 87.498 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities | ActiGraph Wrist: Activity Block 1 | 211.15 Steps | Standard Deviation 80.045 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities | ActiGraph Wrist: Activity Block 2 | 225.69 Steps | Standard Deviation 98.155 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities | APDM: Activity Block 2 | 154.15 Steps | Standard Deviation 47.43 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities | APDM: Activity Block 1 | 154.62 Steps | Standard Deviation 49.399 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities | ActiGraph Lumbar: Activity Block 2 | 109.15 Steps | Standard Deviation 72.281 |
Comparison: Activity Block 1: ActiGraph Wrist vs APDM95% CI: [-0.16, 0.53]
Comparison: Activity Block 1: ActiGraph Wrist vs APDM95% CI: [-0.114, 0.64]
Comparison: Activity Block 1: ActiGraph Wrist vs APDM95% CI: [-0.17, 0.73]
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.23, 0.76]
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.12, 0.74]
Comparison: Activity Block 1: ActiGraph Lumbar vs APDM95% CI: [-0.15, 0.74]
Comparison: Activity Block 1: ActiGraph Wrist vs ActiGraph Lumbar95% CI: [-0.18, 0.65]
Comparison: Activity Block 1: ActiGraph Wrist vs ActiGraph Lumbar95% CI: [-0.17, 0.87]
Comparison: Activity Block 1: ActiGraph Wrist vs ActiGraph Lumbar95% CI: [-0.2, 0.75]
Comparison: Activity Block 1: ActiGraph Wrist vs ActiGraph Lumbar vs APDM95% CI: [-0.06, 0.59]
Comparison: Activity Block 1: ActiGraph Wrist vs ActiGraph Lumbar vs APDM95% CI: [-0.1, 0.74]
Comparison: Activity Block 1: ActiGraph Wrist vs ActiGraph Lumbar vs APDM95% CI: [-0.03, 0.7]
Comparison: Activity Block 2: ActiGraph Wrist vs APDM95% CI: [-0.2, 0.77]
Comparison: Activity Block 2: ActiGraph Wrist vs APDM95% CI: [-0.12, 0.56]
Comparison: Activity Block 2: ActiGraph Wrist vs APDM95% CI: [-0.18, 0.71]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [-0.14, 0.8]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [-0.22, 0.65]
Comparison: Activity Block 2: ActiGraph Lumbar vs APDM95% CI: [-0.14, 0.77]
Comparison: Activity Block 2: ActiGraph Wrist vs ActiGraph Lumbar95% CI: [-0.22, 0.86]
Comparison: Activity Block 2: ActiGraph Wrist vs ActiGraph Lumbar95% CI: [-0.18, 0.72]
Comparison: Activity Block 2: ActiGraph Wrist vs ActiGraph Lumbar95% CI: [-0.17, 0.74]
Comparison: Activity Block 2: ActiGraph Wrist vs ActiGraph Lumbar vs APDM95% CI: [-0.02, 0.78]
Comparison: Activity Block 2: ActiGraph Wrist vs Actigraph Lumbar vs APDM95% CI: [-0.08, 0.59]
Comparison: Activity Block 2: ActiGraph Wrist vs ActiGraph Lumbar vs APDM95% CI: [-0.07, 0.7]
Primary
Cohort B: Number of Available Minutes During the At-Home Period
Available minutes represented any recorded accelerometer data per day per device in minutes. Number of available minutes for GENEActiv and Panoramic Bracelet was derived by the in-house built Sci-kit Digital Health (SKDH) package.
Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Available Minutes During the At-Home Period | Panoramic Bracelet | 1389.08 Minutes | Standard Deviation 28.718 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Available Minutes During the At-Home Period | GENEActiv | 1234.49 Minutes | Standard Deviation 173.436 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Available Minutes During the At-Home Period | Panoramic Bracelet | 1386.44 Minutes | Standard Deviation 50.327 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Available Minutes During the At-Home Period | GENEActiv | 1260.18 Minutes | Standard Deviation 129.136 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Available Minutes During the At-Home Period | Panoramic Bracelet | 1385.76 Minutes | Standard Deviation 28.941 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Available Minutes During the At-Home Period | GENEActiv | 1310.20 Minutes | Standard Deviation 86.365 |
Primary
Cohort B: Number of Minutes of Wear During the At-Home Period
Number of minutes of wear include the total number of minutes the device is worn including sleep time and awake time. The wear time parameter (number of minutes of wear) for GENEActiv and Panoramic Bracelet was derived by the in-house built SKDH package.
Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Minutes of Wear During the At-Home Period | Panoramic Bracelet | 1095.45 Minutes | Standard Deviation 145.296 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Minutes of Wear During the At-Home Period | GENEActiv | 727.98 Minutes | Standard Deviation 226.617 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Minutes of Wear During the At-Home Period | Panoramic Bracelet | 1099.07 Minutes | Standard Deviation 185.868 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Minutes of Wear During the At-Home Period | GENEActiv | 785.81 Minutes | Standard Deviation 195.558 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Minutes of Wear During the At-Home Period | Panoramic Bracelet | 1044.66 Minutes | Standard Deviation 153.988 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Minutes of Wear During the At-Home Period | GENEActiv | 789.37 Minutes | Standard Deviation 181.889 |
Primary
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Wearability/comfort questionnaire included a total of 10 items for which the participants (12 to 17 years) or their caregivers (participants aged 3 to 11 years) were required to provide a response on a scale of 0 to 4, where 0 = strongly disagree, and 4 = strongly agree, higher scores indicated more comfort, except for questions 5 (The device changes the way I move) and 6 (The device changes the way I behave) , where 0 = strongly agree and 4 = strongly disagree, higher scores indicate more comfort. Number of participants according to response to each item of the wearability/comfort questionnaire is reported.
Time frame: Day 7
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Take Off | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Comfortable to Wear | 1 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Comfortable to Wear | 2 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Comfortable to Wear | 3 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Comfortable to Wear | 4 | 5 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Put On | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Put On | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Put On | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Put On | 3 | 9 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Put On | 4 | 4 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Take Off | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Take Off | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Comfortable to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Take Off | 3 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Take Off | 4 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Wear | 2 | 2 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Wear | 3 | 8 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Wear | 4 | 3 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Move | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Move | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Move | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Move | 3 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Move | 4 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Behave | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Behave | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Behave | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Behave | 3 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Behave | 4 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for 4 to 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for 4 to 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for 4 to 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for 4 to 7 Days | 3 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for 4 to 7 Days | 4 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for > 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for > 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for > 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for > 7 Days | 3 | 9 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for > 7 Days | 4 | 4 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If the device could follow my progress during a treatment (ttmt), I would wear it | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If the device could follow my progress during a treatment (ttmt), I would wear it | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If the device could follow my progress during a treatment (ttmt), I would wear it | 2 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If the device could follow my progress during a treatment (ttmt), I would wear it | 3 | 5 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If the device could follow my progress during a treatment (ttmt), I would wear it | 4 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If device could follow my progress during ttmt, I would want my doctor to have access to my results | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If device could follow my progress during ttmt, I would want my doctor to have access to my results | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If device could follow my progress during ttmt, I would want my doctor to have access to my results | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If device could follow my progress during ttmt, I would want my doctor to have access to my results | 3 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If device could follow my progress during ttmt, I would want my doctor to have access to my results | 4 | 7 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Wear | 1 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If device could follow my progress during ttmt, I would want my doctor to have access to my results | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Wear | 2 | 2 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for > 7 Days | 4 | 8 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Wear | 3 | 7 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Wear | 4 | 7 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Move | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If the device could follow my progress during a treatment (ttmt), I would wear it | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Move | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Move | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Move | 3 | 5 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If the device could follow my progress during a treatment (ttmt), I would wear it | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Move | 4 | 12 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Behave | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If device could follow my progress during ttmt, I would want my doctor to have access to my results | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Behave | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If the device could follow my progress during a treatment (ttmt), I would wear it | 2 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Behave | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Behave | 3 | 7 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Behave | 4 | 10 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If the device could follow my progress during a treatment (ttmt), I would wear it | 3 | 8 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for 4 to 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for 4 to 7 Days | 1 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If device could follow my progress during ttmt, I would want my doctor to have access to my results | 4 | 8 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for 4 to 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If the device could follow my progress during a treatment (ttmt), I would wear it | 4 | 8 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for 4 to 7 Days | 3 | 5 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Comfortable to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Comfortable to Wear | 1 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Comfortable to Wear | 2 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for 4 to 7 Days | 4 | 11 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Comfortable to Wear | 3 | 8 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Comfortable to Wear | 4 | 7 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If device could follow my progress during ttmt, I would want my doctor to have access to my results | 3 | 9 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Put On | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for > 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Put On | 1 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Put On | 2 | 3 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If device could follow my progress during ttmt, I would want my doctor to have access to my results | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Put On | 3 | 7 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for > 7 Days | 1 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Put On | 4 | 6 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Take Off | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Take Off | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for > 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Take Off | 2 | 3 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Take Off | 3 | 7 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Take Off | 4 | 7 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for > 7 Days | 3 | 8 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Put On | 3 | 7 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Comfortable to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Wear | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for 4 to 7 Days | 3 | 8 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Take Off | 3 | 7 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Wear | 3 | 6 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for > 7 Days | 4 | 8 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Comfortable to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Wear | 4 | 11 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If device could follow my progress during ttmt, I would want my doctor to have access to my results | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If the device could follow my progress during a treatment (ttmt), I would wear it | 4 | 11 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Move | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Put On | 4 | 7 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Comfortable to Wear | 2 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Move | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If the device could follow my progress during a treatment (ttmt), I would wear it | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for > 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Move | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If device could follow my progress during ttmt, I would want my doctor to have access to my results | 4 | 11 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If device could follow my progress during ttmt, I would want my doctor to have access to my results | 3 | 6 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Move | 3 | 3 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Comfortable to Wear | 3 | 11 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for 4 to 7 Days | 4 | 9 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Move | 4 | 14 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If the device could follow my progress during a treatment (ttmt), I would wear it | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Take Off | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Behave | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Comfortable to Wear | 4 | 5 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If device could follow my progress during ttmt, I would want my doctor to have access to my results | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Behave | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Put On | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Behave | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If the device could follow my progress during a treatment (ttmt), I would wear it | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Take Off | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Behave | 3 | 4 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If device could follow my progress during ttmt, I would want my doctor to have access to my results | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Take Off | 4 | 10 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Changes the Way I Behave | 4 | 13 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Put On | 1 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for > 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for 4 to 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | If the device could follow my progress during a treatment (ttmt), I would wear it | 3 | 6 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for > 7 Days | 3 | 9 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for 4 to 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Put On | 2 | 2 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Easy to Take Off | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for 4 to 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 | Willing to Wear for > 7 Days | 2 | 0 Participants |
Primary
Cohort B: Number of Wake Bouts During the At-Home Period
Number of wake bouts for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.
Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Wake Bouts During the At-Home Period | GENEActiv | 9.69 Wake bouts | Standard Deviation 2.579 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Wake Bouts During the At-Home Period | Panoramic Bracelet | 8.74 Wake bouts | Standard Deviation 2.895 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Wake Bouts During the At-Home Period | Panoramic Bracelet | 9.59 Wake bouts | Standard Deviation 4.436 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Wake Bouts During the At-Home Period | GENEActiv | 9.57 Wake bouts | Standard Deviation 4.979 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Wake Bouts During the At-Home Period | Panoramic Bracelet | 9.40 Wake bouts | Standard Deviation 4.171 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Wake Bouts During the At-Home Period | GENEActiv | 9.37 Wake bouts | Standard Deviation 4.651 |
Primary
Cohort B: Number of Wear Minutes While Awake During the At-Home Period
The wear time parameter (number of wear minutes while awake) for GENEActiv and Panoramic Bracelet was derived by the in-house built SKDH package.
Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Wear Minutes While Awake During the At-Home Period | Panoramic Bracelet | 813.15 Minutes | Standard Deviation 47.851 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Wear Minutes While Awake During the At-Home Period | GENEActiv | 706.48 Minutes | Standard Deviation 85.259 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Wear Minutes While Awake During the At-Home Period | Panoramic Bracelet | 883.23 Minutes | Standard Deviation 73.627 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Wear Minutes While Awake During the At-Home Period | GENEActiv | 768.64 Minutes | Standard Deviation 99.152 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Wear Minutes While Awake During the At-Home Period | Panoramic Bracelet | 845.01 Minutes | Standard Deviation 85.179 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Wear Minutes While Awake During the At-Home Period | GENEActiv | 775.16 Minutes | Standard Deviation 152.259 |
Primary
Cohort B: Percentage of Time Asleep During the At-Home Period
The percentage of time asleep for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.
Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Percentage of Time Asleep During the At-Home Period | Panoramic Bracelet | 95.65 Percentage of time | Standard Deviation 1.745 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Percentage of Time Asleep During the At-Home Period | GENEActiv | 94.85 Percentage of time | Standard Deviation 2.258 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Percentage of Time Asleep During the At-Home Period | Panoramic Bracelet | 94.93 Percentage of time | Standard Deviation 2.049 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Percentage of Time Asleep During the At-Home Period | GENEActiv | 94.94 Percentage of time | Standard Deviation 2.402 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Percentage of Time Asleep During the At-Home Period | Panoramic Bracelet | 94.85 Percentage of time | Standard Deviation 2.481 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Percentage of Time Asleep During the At-Home Period | GENEActiv | 94.08 Percentage of time | Standard Deviation 2.762 |
Primary
Cohort B: Sleep Onset Latency During the At-Home Period
Sleep onset latency which is time to transition from full wakefulness to sleep, for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.
Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Sleep Onset Latency During the At-Home Period | Panoramic Bracelet | 2.64 Minutes | Standard Deviation 0.868 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Sleep Onset Latency During the At-Home Period | GENEActiv | 3.69 Minutes | Standard Deviation 1.966 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Sleep Onset Latency During the At-Home Period | Panoramic Bracelet | 3.82 Minutes | Standard Deviation 1.118 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Sleep Onset Latency During the At-Home Period | GENEActiv | 4.01 Minutes | Standard Deviation 1.425 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Sleep Onset Latency During the At-Home Period | Panoramic Bracelet | 2.39 Minutes | Standard Deviation 1.428 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Sleep Onset Latency During the At-Home Period | GENEActiv | 3.64 Minutes | Standard Deviation 2.291 |
Primary
Cohort B: Total Scratch Duration During the At-Home Period
Total scratch duration for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.
Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Total Scratch Duration During the At-Home Period | Panoramic Bracelet | 2.45 Minutes | Standard Deviation 0.785 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Total Scratch Duration During the At-Home Period | GENEActiv | 3.17 Minutes | Standard Deviation 1.138 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Total Scratch Duration During the At-Home Period | Panoramic Bracelet | 3.29 Minutes | Standard Deviation 1.453 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Total Scratch Duration During the At-Home Period | GENEActiv | 3.19 Minutes | Standard Deviation 1.456 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Total Scratch Duration During the At-Home Period | Panoramic Bracelet | 3.35 Minutes | Standard Deviation 1.576 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Total Scratch Duration During the At-Home Period | GENEActiv | 3.75 Minutes | Standard Deviation 2.032 |
Primary
Cohort B: Total Scratch Episodes During the At-Home Period
Total scratch episodes for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.
Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Total Scratch Episodes During the At-Home Period | Panoramic Bracelet | 34.74 Scratch episodes | Standard Deviation 9.585 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Total Scratch Episodes During the At-Home Period | GENEActiv | 43.81 Scratch episodes | Standard Deviation 14.447 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Total Scratch Episodes During the At-Home Period | Panoramic Bracelet | 45.60 Scratch episodes | Standard Deviation 17.613 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Total Scratch Episodes During the At-Home Period | GENEActiv | 43.45 Scratch episodes | Standard Deviation 16.683 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Total Scratch Episodes During the At-Home Period | Panoramic Bracelet | 46.04 Scratch episodes | Standard Deviation 19.338 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Total Scratch Episodes During the At-Home Period | GENEActiv | 49.74 Scratch episodes | Standard Deviation 25.354 |
Primary
Cohort B: Total Sleep Time During the At-Home Period
Total sleep time for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's total sleep opportunity (TSO) window and computing sleep metrics within that window.
Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Total Sleep Time During the At-Home Period | Panoramic Bracelet | 561.21 Minutes | Standard Deviation 43.476 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Total Sleep Time During the At-Home Period | GENEActiv | 567.48 Minutes | Standard Deviation 40.483 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Total Sleep Time During the At-Home Period | Panoramic Bracelet | 520.34 Minutes | Standard Deviation 26.68 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Total Sleep Time During the At-Home Period | GENEActiv | 524.57 Minutes | Standard Deviation 42.583 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Total Sleep Time During the At-Home Period | Panoramic Bracelet | 459.92 Minutes | Standard Deviation 44.421 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Total Sleep Time During the At-Home Period | GENEActiv | 450.53 Minutes | Standard Deviation 54.944 |
Primary
Cohort B: Wake After Sleep Onset During the At-Home Period
Wake after sleep onset is time for which participants were awake after having initially fallen asleep, for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.
Time frame: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActiv
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Wake After Sleep Onset During the At-Home Period | Panoramic Bracelet | 22.38 Minutes | Standard Deviation 9.022 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Wake After Sleep Onset During the At-Home Period | GENEActiv | 26.44 Minutes | Standard Deviation 13.112 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Wake After Sleep Onset During the At-Home Period | Panoramic Bracelet | 24.36 Minutes | Standard Deviation 12.82 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Wake After Sleep Onset During the At-Home Period | GENEActiv | 23.58 Minutes | Standard Deviation 15.339 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Wake After Sleep Onset During the At-Home Period | Panoramic Bracelet | 21.62 Minutes | Standard Deviation 12.976 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Wake After Sleep Onset During the At-Home Period | GENEActiv | 22.01 Minutes | Standard Deviation 12.396 |
Secondary
Cohort A: Cadence Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
Cadence referred to the number of steps taken per minute during gait cycle. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Cadence Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | ActiGraph: Carpet | 115.08 Steps per minute | Standard Error 2.236 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Cadence Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | APDM: Carpet | 116.79 Steps per minute | Standard Error 2.24 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Cadence Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | ActiGraph: Tile | 117.56 Steps per minute | Standard Error 2.236 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Cadence Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | APDM: Tile | 119.62 Steps per minute | Standard Error 2.236 |
Secondary
Cohort A: Double Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had a single in-lab visit during which they performed gait monitoring procedures. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Double Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | ActiGraph: Carpet | 0.28 Seconds | Standard Error 0.007 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Double Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | APDM: Carpet | 0.20 Seconds | Standard Error 0.007 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Double Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | ActiGraph: Tile | 0.28 Seconds | Standard Error 0.007 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Double Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | APDM: Tile | 0.19 Seconds | Standard Error 0.007 |
Secondary
Cohort A: Gait Speed Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
Gait speed was the time taken to walk a specified distance. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Gait Speed Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | ActiGraph: Carpet | 0.95 Meters per second | Standard Error 0.027 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Gait Speed Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | APDM: Carpet | 0.97 Meters per second | Standard Error 0.027 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Gait Speed Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | ActiGraph: Tile | 0.97 Meters per second | Standard Error 0.027 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Gait Speed Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | APDM: Tile | 1.00 Meters per second | Standard Error 0.027 |
Secondary
Cohort A: Number of Days With More Than 10 Hours of Wear Time for Lumbar Device
Time frame: From Day 1 to Day 15 (+ 3 days)
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Days With More Than 10 Hours of Wear Time for Lumbar Device | 6.15 Days | Standard Deviation 4.413 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Days With More Than 10 Hours of Wear Time for Lumbar Device | 11.71 Days | Standard Deviation 3.561 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Days With More Than 10 Hours of Wear Time for Lumbar Device | 11.69 Days | Standard Deviation 2.25 |
Secondary
Cohort A: Number of Days With More Than 18 Hours of Wear Time for Wrist Device
Time frame: From Day 1 to Day 15 (+ 3 days)
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Days With More Than 18 Hours of Wear Time for Wrist Device | 12.38 Days | Standard Deviation 2.534 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Days With More Than 18 Hours of Wear Time for Wrist Device | 13.21 Days | Standard Deviation 1.718 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Days With More Than 18 Hours of Wear Time for Wrist Device | 12.54 Days | Standard Deviation 2.436 |
Secondary
Cohort A: Number of Hours Per Day Wearing the Lumbar and Wrist Devices
Time frame: From Day 1 to Day 15 (+ 3 days)
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Hours Per Day Wearing the Lumbar and Wrist Devices | Wrist device | 21.05 Hours per day | Standard Deviation 2.461 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Hours Per Day Wearing the Lumbar and Wrist Devices | Lumbar device | 7.24 Hours per day | Standard Deviation 4.293 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Hours Per Day Wearing the Lumbar and Wrist Devices | Wrist device | 21.80 Hours per day | Standard Deviation 1.947 |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Hours Per Day Wearing the Lumbar and Wrist Devices | Lumbar device | 12.51 Hours per day | Standard Deviation 3.63 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Hours Per Day Wearing the Lumbar and Wrist Devices | Wrist device | 22.01 Hours per day | Standard Deviation 2.169 |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Hours Per Day Wearing the Lumbar and Wrist Devices | Lumbar device | 14.24 Hours per day | Standard Deviation 4.574 |
Secondary
Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks
Number of participants who were able to perform each of the 7 tasks (i.e., walking at natural, slow and fast speeds, tile and carpet walks, 2 sessions of in-lab simulated activities) is reported in this outcome measure.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Fast Walk | 13 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Tile Walk | 13 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Carpet Walk | 13 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Natural Walk | 13 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Activity Block 2 | 13 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Activity Block 1 | 13 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Slow Walk | 13 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Carpet Walk | 14 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Natural Walk | 14 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Fast Walk | 14 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Slow Walk | 14 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Tile Walk | 14 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Activity Block 1 | 14 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Activity Block 2 | 14 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Tile Walk | 13 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Fast Walk | 13 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Activity Block 2 | 13 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Activity Block 1 | 13 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Carpet Walk | 13 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Slow Walk | 13 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks | Natural Walk | 13 Participants |
Secondary
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
Wearability/comfort questionnaire included a total of 10 items for which the participants (12 to 17 years) or their caregivers (participants aged 3 to 11 years) were required to provide a response on a scale of 0 to 4, where 0 = strongly disagree, and 4 = strongly agree, higher scores indicate more comfort except for questions 5 (The device changes the way I move) and 6 (The device changes the way I behave) , where 0 = strongly agree and 4 = strongly disagree, higher scores indicate more comfort. Number of participants according to response to each item of the wearability/comfort questionnaire is reported.
Time frame: Day 15 (+ 3 days)
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Take Off | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for 4 to 7 Days | 4 | 3 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 4 | 3 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for > 7 Days | 0 | 2 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for > 7 Days | 3 | 4 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Take Off | 4 | 8 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for > 7 Days | 1 | 2 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Take Off | 2 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Take Off | 3 | 4 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for > 7 Days | 2 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 0 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Take Off | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for > 7 Days | 3 | 5 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for > 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Take Off | 1 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for > 7 Days | 4 | 3 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Take Off | 3 | 4 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Take Off | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: If the device could follow my progress during a treatment, I would wear it | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 3 | 3 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Put On | 4 | 8 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: If the device could follow my progress during a treatment, I would wear it | 1 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for > 7 Days | 1 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Put On | 3 | 4 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: If the device could follow my progress during a treatment, I would wear it | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Take Off | 4 | 8 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Put On | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: If the device could follow my progress during a treatment, I would wear it | 3 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Put On | 1 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: If the device could follow my progress during a treatment, I would wear it | 4 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for > 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Put On | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 4 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 3 | 5 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Put On | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for 4 to 7 Days | 4 | 10 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 1 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 3 | 3 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Wear | 1 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 4 | 10 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for 4 to 7 Days | 3 | 3 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Wear | 2 | 2 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: If the device could follow my progress during a ttmt, I would wear it | 4 | 9 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for 4 to 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Wear | 3 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Put On | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for 4 to 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Wear | 4 | 3 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 1 | 2 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for 4 to 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Move | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: If the device could follow my progress during a ttmt, I would wear it | 3 | 4 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Behave | 4 | 8 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Move | 1 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Put On | 2 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Behave | 3 | 5 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Move | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Behave | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Move | 3 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: If the device could follow my progress during a ttmt, I would wear it | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Behave | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Move | 4 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Put On | 3 | 5 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Behave | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Behave | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 3 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Move | 4 | 9 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Behave | 1 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: If the device could follow my progress during a ttmt, I would wear it | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Move | 3 | 4 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Behave | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Put On | 4 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Move | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Behave | 3 | 5 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 4 | 10 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Move | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Behave | 4 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: If the device could follow my progress during a ttmt, I would wear it | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Move | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for 4 to 7 Days | 0 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Take Off | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Wear | 4 | 8 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for 4 to 7 Days | 1 | 2 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Wear | 3 | 5 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for 4 to 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for > 7 Days | 4 | 8 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Wear | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for 4 to 7 Days | 3 | 7 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Take Off | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 2 | 2 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 3 | 8 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 4 | 4 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Put On | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Put On | 1 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Put On | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Put On | 3 | 5 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Put On | 4 | 8 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Take Off | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Take Off | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Take Off | 3 | 5 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Take Off | 4 | 9 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Wear | 1 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Wear | 2 | 2 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Wear | 3 | 5 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Wear | 4 | 6 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Move | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Move | 1 | 2 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Move | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Move | 3 | 3 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Move | 4 | 9 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Behave | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Behave | 1 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Behave | 2 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Behave | 3 | 2 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Behave | 4 | 10 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for 4 to 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for 4 to 7 Days | 1 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for 4 to 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for 4 to 7 Days | 3 | 6 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for 4 to 7 Days | 4 | 7 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for > 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for > 7 Days | 1 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for > 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for > 7 Days | 3 | 8 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for > 7 Days | 4 | 5 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: If the device could follow my progress during a treatment, I would wear it | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: If the device could follow my progress during a treatment, I would wear it | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: If the device could follow my progress during a treatment, I would wear it | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: If the device could follow my progress during a treatment, I would wear it | 3 | 5 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: If the device could follow my progress during a treatment, I would wear it | 4 | 9 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 3 | 4 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 4 | 10 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 3 | 5 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 4 | 9 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Put On | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Put On | 1 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Put On | 2 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Put On | 3 | 6 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Put On | 4 | 6 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Take Off | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Take Off | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Take Off | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Take Off | 3 | 8 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Take Off | 4 | 6 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Wear | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Wear | 3 | 5 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Wear | 4 | 9 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Move | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Move | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Move | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Move | 3 | 2 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Move | 4 | 12 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Behave | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Behave | 1 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Behave | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Behave | 3 | 2 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Behave | 4 | 11 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for 4 to 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for 4 to 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for 4 to 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for 4 to 7 Days | 3 | 5 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for 4 to 7 Days | 4 | 9 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for > 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for > 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for > 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for > 7 Days | 3 | 5 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for > 7 Days | 4 | 9 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: If the device could follow my progress during a ttmt, I would wear it | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: If the device could follow my progress during a ttmt, I would wear it | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: If the device could follow my progress during a ttmt, I would wear it | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: If the device could follow my progress during a ttmt, I would wear it | 3 | 5 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: If the device could follow my progress during a ttmt, I would wear it | 4 | 9 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 3 | 3 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 4 | 11 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for 4 to 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Take Off | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Wear | 2 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for 4 to 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 3 | 4 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Wear | 3 | 4 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for 4 to 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for > 7 Days | 4 | 8 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Wear | 4 | 8 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Behave | 4 | 9 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Put On | 4 | 8 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Move | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Behave | 3 | 4 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Move | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Behave | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: If the device could follow my progress during a ttmt, I would wear it | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Move | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Behave | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Put On | 3 | 3 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Move | 3 | 2 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Behave | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 2 | 4 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Move | 4 | 11 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Move | 4 | 7 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: If the device could follow my progress during a ttmt, I would wear it | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Behave | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Move | 3 | 6 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Put On | 2 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Behave | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Move | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Behave | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Move | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: If the device could follow my progress during a ttmt, I would wear it | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Behave | 3 | 3 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Changes the Way I Move | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Put On | 1 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Changes the Way I Behave | 4 | 10 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Wear | 4 | 6 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for 4 to 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Wear | 3 | 2 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: If the device could follow my progress during a ttmt, I would wear it | 3 | 3 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for 4 to 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Wear | 2 | 4 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Put On | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for 4 to 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Wear | 1 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 4 | 9 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 3 | 4 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 1 | 2 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for 4 to 7 Days | 3 | 5 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 2 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: If the device could follow my progress during a ttmt, I would wear it | 4 | 10 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 3 | 5 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: If the device could follow my progress during a treatment, I would wear it | 4 | 10 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for 4 to 7 Days | 4 | 8 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 4 | 7 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Take Off | 4 | 10 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Put On | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: If the device could follow my progress during a treatment, I would wear it | 3 | 3 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 4 | 4 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Put On | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: If the device could follow my progress during a treatment, I would wear it | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for > 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Put On | 2 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: If the device could follow my progress during a treatment, I would wear it | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Take Off | 3 | 3 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Put On | 3 | 5 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: If the device could follow my progress during a treatment, I would wear it | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 4 | 9 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Put On | 4 | 7 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for > 7 Days | 4 | 8 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for > 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Take Off | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for > 7 Days | 3 | 4 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Take Off | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Take Off | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for > 7 Days | 2 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Take Off | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for > 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for > 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Take Off | 3 | 4 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for > 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Easy to Take Off | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Take Off | 4 | 9 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for 4 to 7 Days | 4 | 8 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 3 | 3 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Easy to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT L: Willing to Wear for 4 to 7 Days | 3 | 5 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation | ACT W: Willing to Wear for > 7 Days | 3 | 5 Participants |
Secondary
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
Wearability/comfort questionnaire included a total of 10 items for which the participants (12 to 17 years) or their caregivers (participants aged 3 to 11 years) were required to provide a response on a scale of 0 to 4, where 0 = strongly disagree, and 4 = strongly agree, higher scores indicate more comfort except for questions 5 (The device changes the way I move) and 6 (The device changes the way I behave) , where 0 = strongly agree and 4 = strongly disagree, higher scores indicate more comfort. Number of participants according to response to each item of the wearability/comfort questionnaire is reported.
Time frame: Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Wear | 2 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 1 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Put On | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 4 | 9 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for 4 to 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 3 | 4 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 3 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Wear | 3 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 4 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Comfortable to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Put On | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for 4 to 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Put On | 1 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Wear | 4 | 4 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: If the device could follow my progress during a treatment, I would wear it | 4 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Put On | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: If the device could follow my progress during a ttmt, I would wear it | 3 | 5 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: If the device could follow my progress during a treatment, I would wear it | 3 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Put On | 3 | 5 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for 4 to 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: If the device could follow my progress during a treatment, I would wear it | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Put On | 4 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Move | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: If the device could follow my progress during a treatment, I would wear it | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Take Off | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Put On | 2 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: If the device could follow my progress during a treatment, I would wear it | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Take Off | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Behave | 4 | 8 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for > 7 Days | 4 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Take Off | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Move | 1 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for > 7 Days | 3 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Take Off | 3 | 5 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for > 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Take Off | 4 | 8 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Behave | 3 | 2 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for > 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Move | 2 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for > 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Wear | 1 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: If the device could follow my progress during a ttmt, I would wear it | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for 4 to 7 Days | 4 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Wear | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Behave | 2 | 2 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for 4 to 7 Days | 3 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Wear | 3 | 5 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Move | 3 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for 4 to 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Wear | 4 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Put On | 3 | 5 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for 4 to 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Move | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Behave | 1 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for 4 to 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Move | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Move | 4 | 4 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Behave | 4 | 9 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Move | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Comfortable to Wear | 3 | 4 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Behave | 3 | 3 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Move | 3 | 4 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Behave | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Behave | 2 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Move | 4 | 9 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Behave | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Behave | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Behave | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: If the device could follow my progress during a ttmt, I would wear it | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Move | 4 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Behave | 1 | 2 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Put On | 4 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Move | 3 | 4 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Behave | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 4 | 10 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Move | 2 | 2 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Behave | 3 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: If the device could follow my progress during a ttmt, I would wear it | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Move | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Behave | 4 | 5 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Take Off | 0 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Move | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for 4 to 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Wear | 4 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for 4 to 7 Days | 1 | 3 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for > 7 Days | 4 | 5 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Wear | 3 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for 4 to 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Take Off | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Wear | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for 4 to 7 Days | 3 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Comfortable to Wear | 4 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for 4 to 7 Days | 4 | 4 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for > 7 Days | 3 | 7 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for > 7 Days | 0 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Take Off | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Take Off | 4 | 9 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for > 7 Days | 1 | 2 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 3 | 3 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Take Off | 3 | 4 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for > 7 Days | 2 | 3 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for > 7 Days | 2 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Comfortable to Wear | 0 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for > 7 Days | 3 | 3 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Take Off | 3 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Take Off | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for > 7 Days | 4 | 4 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Take Off | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If the device could follow my progress during a treatment, I would wear it | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for > 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Take Off | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If the device could follow my progress during a treatment, I would wear it | 1 | 2 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Take Off | 4 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Put On | 4 | 9 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If the device could follow my progress during a treatment, I would wear it | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Put On | 0 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Put On | 3 | 2 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If the device could follow my progress during a treatment, I would wear it | 3 | 5 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for > 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Put On | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If the device could follow my progress during a treatment, I would wear it | 4 | 6 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Wear | 0 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Put On | 1 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results | 0 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Comfortable to Wear | 2 | 2 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Put On | 0 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for 4 to 7 Days | 4 | 9 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 4 | 8 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results | 2 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 3 | 3 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results | 3 | 5 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: If the device could follow my progress during a ttmt, I would wear it | 4 | 8 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 2 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results | 4 | 8 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for 4 to 7 Days | 3 | 4 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 1 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Take Off | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Comfortable to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Comfortable to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Comfortable to Wear | 2 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Comfortable to Wear | 3 | 9 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Comfortable to Wear | 4 | 4 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Put On | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Put On | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Put On | 2 | 4 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Put On | 3 | 4 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Put On | 4 | 6 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Take Off | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Take Off | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Take Off | 2 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Take Off | 3 | 6 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Take Off | 4 | 7 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Wear | 2 | 2 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Wear | 3 | 6 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Wear | 4 | 6 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Move | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Move | 1 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Move | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Move | 3 | 2 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Move | 4 | 11 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Behave | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Behave | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Behave | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Behave | 3 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Behave | 4 | 13 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for 4 to 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for 4 to 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for 4 to 7 Days | 2 | 3 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for 4 to 7 Days | 3 | 4 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for 4 to 7 Days | 4 | 7 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for > 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for > 7 Days | 1 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for > 7 Days | 2 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for > 7 Days | 3 | 6 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for > 7 Days | 4 | 6 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If the device could follow my progress during a treatment, I would wear it | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If the device could follow my progress during a treatment, I would wear it | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If the device could follow my progress during a treatment, I would wear it | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If the device could follow my progress during a treatment, I would wear it | 3 | 6 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If the device could follow my progress during a treatment, I would wear it | 4 | 8 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results | 3 | 5 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results | 4 | 9 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 2 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 3 | 8 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 4 | 5 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Put On | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Put On | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Put On | 2 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Put On | 3 | 4 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Put On | 4 | 9 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Take Off | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Take Off | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Take Off | 2 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Take Off | 3 | 2 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Take Off | 4 | 11 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Wear | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Wear | 3 | 6 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Wear | 4 | 8 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Move | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Move | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Move | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Move | 3 | 2 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Move | 4 | 12 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Behave | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Behave | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Behave | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Behave | 3 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Behave | 4 | 13 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for 4 to 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for 4 to 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for 4 to 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for 4 to 7 Days | 3 | 3 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for 4 to 7 Days | 4 | 11 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for > 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for > 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for > 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for > 7 Days | 3 | 4 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for > 7 Days | 4 | 10 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: If the device could follow my progress during a treatment, I would wear it | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: If the device could follow my progress during a treatment, I would wear it | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: If the device could follow my progress during a treatment, I would wear it | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: If the device could follow my progress during a treatment, I would wear it | 3 | 4 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: If the device could follow my progress during a treatment, I would wear it | 4 | 10 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Take Off | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 3 | 5 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 4 | 9 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 2 | 2 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 3 | 4 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 4 | 8 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Put On | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Put On | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Put On | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Put On | 3 | 6 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Put On | 4 | 8 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Take Off | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Take Off | 3 | 8 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Take Off | 4 | 6 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Wear | 2 | 1 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Wear | 3 | 6 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Wear | 4 | 7 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Move | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Move | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Move | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Move | 3 | 4 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Move | 4 | 10 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Behave | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Behave | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Behave | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Behave | 3 | 3 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Behave | 4 | 11 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for 4 to 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for 4 to 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for 4 to 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for 4 to 7 Days | 3 | 3 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for 4 to 7 Days | 4 | 11 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for > 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for > 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for > 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for > 7 Days | 3 | 3 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for > 7 Days | 4 | 11 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: If the device could follow my progress during a ttmt, I would wear it | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: If the device could follow my progress during a ttmt, I would wear it | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: If the device could follow my progress during a ttmt, I would wear it | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: If the device could follow my progress during a ttmt, I would wear it | 3 | 3 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: If the device could follow my progress during a ttmt, I would wear it | 4 | 11 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 0 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 1 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 2 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 3 | 4 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 4 | 10 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 4 | 7 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results | 4 | 7 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: If the device could follow my progress during a ttmt, I would wear it | 4 | 9 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results | 3 | 6 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for 4 to 7 Days | 4 | 9 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 2 | 2 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Take Off | 4 | 2 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 3 | 8 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Comfortable to Wear | 4 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Wrist (W): Comfortable to Wear | 4 | 3 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for > 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Put On | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If the device could follow my progress during a treatment, I would wear it | 4 | 8 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Take Off | 3 | 6 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Put On | 1 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If the device could follow my progress during a treatment, I would wear it | 3 | 5 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 4 | 7 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Put On | 2 | 2 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If the device could follow my progress during a treatment, I would wear it | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for > 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Put On | 3 | 5 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If the device could follow my progress during a treatment, I would wear it | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Take Off | 2 | 2 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Put On | 4 | 5 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: If the device could follow my progress during a treatment, I would wear it | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Take Off | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for > 7 Days | 4 | 2 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Take Off | 1 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for > 7 Days | 3 | 7 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for > 7 Days | 2 | 3 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Take Off | 2 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for > 7 Days | 1 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for > 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Take Off | 3 | 4 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for > 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Take Off | 1 | 3 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Take Off | 4 | 7 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for 4 to 7 Days | 4 | 3 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Comfortable to Wear | 3 | 6 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for 4 to 7 Days | 3 | 9 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for > 7 Days | 3 | 4 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for 4 to 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Take Off | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Wear | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for 4 to 7 Days | 1 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 3 | 6 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Wear | 3 | 6 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Willing to Wear for 4 to 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for > 7 Days | 4 | 9 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Easy to Wear | 4 | 6 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Behave | 4 | 5 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Put On | 4 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Move | 0 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Behave | 3 | 7 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Move | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Behave | 2 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: If the device could follow my progress during a ttmt, I would wear it | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Move | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Behave | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Put On | 3 | 6 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Move | 3 | 5 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Behave | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Comfortable to Wear | 2 | 5 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Move | 4 | 7 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Move | 4 | 3 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: If the device could follow my progress during a ttmt, I would wear it | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Behave | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Move | 4 | 5 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Behave | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Behave | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Move | 3 | 7 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Move | 3 | 6 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Behave | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Move | 2 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Put On | 2 | 5 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Behave | 3 | 5 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Move | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Behave | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Behave | 4 | 8 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Changes the Way I Move | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Move | 2 | 4 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for 4 to 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Wear | 4 | 4 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Comfortable to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for 4 to 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Wear | 3 | 8 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Behave | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for 4 to 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Wear | 2 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Move | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for 4 to 7 Days | 3 | 5 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: If the device could follow my progress during a ttmt, I would wear it | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for 4 to 7 Days | 4 | 8 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Wear | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Behave | 3 | 3 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for > 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Take Off | 4 | 5 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Changes the Way I Move | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for > 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Take Off | 3 | 7 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Put On | 1 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for > 7 Days | 2 | 2 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Take Off | 2 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Changes the Way I Behave | 4 | 10 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for > 7 Days | 3 | 3 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Take Off | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Wear | 4 | 3 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Willing to Wear for > 7 Days | 4 | 8 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Take Off | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: If the device could follow my progress during a treatment, I would wear it | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Put On | 4 | 2 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for 4 to 7 Days | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: If the device could follow my progress during a treatment, I would wear it | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Put On | 3 | 7 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Wear | 3 | 9 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: If the device could follow my progress during a treatment, I would wear it | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Put On | 2 | 4 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: If the device could follow my progress during a ttmt, I would wear it | 3 | 4 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: If the device could follow my progress during a treatment, I would wear it | 3 | 5 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Put On | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for 4 to 7 Days | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: If the device could follow my progress during a treatment, I would wear it | 4 | 8 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L: Easy to Put On | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Wear | 2 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 4 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Put On | 0 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for 4 to 7 Days | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 3 | 8 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Easy to Wear | 1 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 2 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 2 | 3 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | APDM: Comfortable to Wear | 1 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results | 3 | 6 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ActiGraph (ACT) Lumbar (L): Comfortable to Wear | 1 | 1 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 | ACT W: Willing to Wear for 4 to 7 Days | 3 | 4 Participants |
Secondary
Cohort A: Number of Participants Enrolled Over Time
Number of participants enrolled at specified month intervals in the study is reported in this outcome measure.
Time frame: Up to approximately 8 months
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Oct-2021 to 22-Nov-2021 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Aug-2021 to 22-Sep-2021 | 5 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Sep-2021 to 22-Oct-2021 | 2 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Nov-2021 to 22-Dec-2021 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Dec-2021 to 22-Jan-2022 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Jan-2022 to 22-Feb-2022 | 0 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Feb-2022 to 22-Mar-2022 | 1 Participants |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Mar-2022 to 22-Apr-2022 | 3 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Oct-2021 to 22-Nov-2021 | 3 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Feb-2022 to 22-Mar-2022 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Nov-2021 to 22-Dec-2021 | 2 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Dec-2021 to 22-Jan-2022 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Jan-2022 to 22-Feb-2022 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Aug-2021 to 22-Sep-2021 | 3 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Mar-2022 to 22-Apr-2022 | 0 Participants |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Sep-2021 to 22-Oct-2021 | 6 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Sep-2021 to 22-Oct-2021 | 5 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Jan-2022 to 22-Feb-2022 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Oct-2021 to 22-Nov-2021 | 3 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Nov-2021 to 22-Dec-2021 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Feb-2022 to 22-Mar-2022 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Aug-2021 to 22-Sep-2021 | 5 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Dec-2021 to 22-Jan-2022 | 0 Participants |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Number of Participants Enrolled Over Time | 23-Mar-2022 to 22-Apr-2022 | 0 Participants |
Secondary
Cohort A: Percentage of Tasks Completed (From a Total of 7 Tasks)
Percentage of tasks completed from a total of 7 tasks (i.e., walking at natural, slow and fast speeds, tile and carpet walks, 2 sessions of in-lab simulated activities) is reported in this outcome measure.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Percentage of Tasks Completed (From a Total of 7 Tasks) | 100 Percentage of tasks |
| Cohort A: Participants Aged 6-11 Years | Cohort A: Percentage of Tasks Completed (From a Total of 7 Tasks) | 100 Percentage of tasks |
| Cohort A: Participants Aged 12-17 Years | Cohort A: Percentage of Tasks Completed (From a Total of 7 Tasks) | 100 Percentage of tasks |
Secondary
Cohort A: Single Limb Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
Single limb support time referred to the time when only one limb was in contact with the ground. Participants had a single in-lab visit during which they performed gait monitoring procedures. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Single Limb Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | ActiGraph: Carpet | 0.39 Seconds | Standard Error 0.006 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Single Limb Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | APDM: Carpet | 0.42 Seconds | Standard Error 0.006 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Single Limb Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | ActiGraph: Tile | 0.38 Seconds | Standard Error 0.006 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Single Limb Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | APDM: Tile | 0.42 Seconds | Standard Error 0.006 |
Secondary
Cohort A: Stance Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stance Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | ActiGraph: Carpet | 0.67 Seconds | Standard Error 0.012 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stance Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | APDM: Carpet | 0.62 Seconds | Standard Error 0.012 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stance Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | ActiGraph: Tile | 0.66 Seconds | Standard Error 0.012 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stance Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | APDM: Tile | 0.61 Seconds | Standard Error 0.012 |
Secondary
Cohort A: Step Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Step Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | ActiGraph: Carpet | 0.53 Seconds | Standard Error 0.009 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Step Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | APDM: Carpet | 0.52 Seconds | Standard Error 0.009 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Step Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | ActiGraph: Tile | 0.52 Seconds | Standard Error 0.009 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Step Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | APDM: Tile | 0.51 Seconds | Standard Error 0.009 |
Secondary
Cohort A: Stride Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
Stride duration refers to the duration between successive heel contacts of the same foot. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | ActiGraph: Carpet | 1.05 Seconds | Standard Error 0.018 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | APDM: Carpet | 1.04 Seconds | Standard Error 0.018 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | ActiGraph: Tile | 1.04 Seconds | Standard Error 0.018 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | APDM: Tile | 1.02 Seconds | Standard Error 0.018 |
Secondary
Cohort A: Stride Length Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. Participants had a single in-lab visit during which they performed gait monitoring procedures. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Length Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | ActiGraph: Carpet | 1.00 Meters | Standard Error 0.016 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Length Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | APDM: Carpet | 1.01 Meters | Standard Error 0.017 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Length Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | ActiGraph: Tile | 1.00 Meters | Standard Error 0.016 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Stride Length Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | APDM: Tile | 1.01 Meters | Standard Error 0.016 |
Secondary
Cohort A: Swing Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
Swing time was defined as the time during which the foot was not in contact with the ground. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort A: Swing Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | ActiGraph: Tile | 0.38 Seconds | Standard Error 0.006 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Swing Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | ActiGraph: Carpet | 0.39 Seconds | Standard Error 0.006 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Swing Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | APDM: Carpet | 0.42 Seconds | Standard Error 0.006 |
| Cohort A: Participants Aged 3-5 Years | Cohort A: Swing Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis | APDM: Tile | 0.42 Seconds | Standard Error 0.006 |
Secondary
Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Cadence referred to the number of steps taken per minute during gait cycle. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 158.13 Steps per minute | Standard Deviation 28.017 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 106.81 Steps per minute | Standard Deviation 28.903 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 147.01 Steps per minute | Standard Deviation 11.303 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 166.43 Steps per minute | Standard Deviation 20.297 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 138.45 Steps per minute | Standard Deviation 26.272 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 119.25 Steps per minute | Standard Deviation 36.642 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 136.44 Steps per minute | Standard Deviation 7.962 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 144.80 Steps per minute | Standard Deviation 11.373 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 106.99 Steps per minute | Standard Deviation 45.694 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 145.96 Steps per minute | Standard Deviation 16.9 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 119.94 Steps per minute | Standard Deviation 10.909 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 122.16 Steps per minute | Standard Deviation 10.433 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 122.15 Steps per minute | Standard Deviation 10.904 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 144.41 Steps per minute | Standard Deviation 14.793 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 141.76 Steps per minute | Standard Deviation 13.502 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 88.81 Steps per minute | Standard Deviation 24.208 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 93.91 Steps per minute | Standard Deviation 25.728 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 92.80 Steps per minute | Standard Deviation 25.727 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 110.45 Steps per minute | Standard Deviation 7.473 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 108.89 Steps per minute | Standard Deviation 7.163 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 81.21 Steps per minute | Standard Deviation 16.065 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 109.98 Steps per minute | Standard Deviation 7.504 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 82.07 Steps per minute | Standard Deviation 16.271 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 122.86 Steps per minute | Standard Deviation 9.042 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 121.24 Steps per minute | Standard Deviation 9.227 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 82.24 Steps per minute | Standard Deviation 16.459 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 122.66 Steps per minute | Standard Deviation 8.589 |
Secondary
Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 0.24 Seconds | Standard Deviation 0.056 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.34 Seconds | Standard Deviation 0.179 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.13 Seconds | Standard Deviation 0.032 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.15 Seconds | Standard Deviation 0.04 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 0.29 Seconds | Standard Deviation 0.063 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.37 Seconds | Standard Deviation 0.181 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.16 Seconds | Standard Deviation 0.031 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.20 Seconds | Standard Deviation 0.038 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 0.42 Seconds | Standard Deviation 0.166 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.18 Seconds | Standard Deviation 0.041 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 0.32 Seconds | Standard Deviation 0.031 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.25 Seconds | Standard Deviation 0.041 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.17 Seconds | Standard Deviation 0.039 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 0.26 Seconds | Standard Deviation 0.047 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.12 Seconds | Standard Deviation 0.027 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 0.50 Seconds | Standard Deviation 0.183 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.47 Seconds | Standard Deviation 0.243 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.37 Seconds | Standard Deviation 0.199 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.19 Seconds | Standard Deviation 0.041 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 0.34 Seconds | Standard Deviation 0.035 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 0.51 Seconds | Standard Deviation 0.121 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.31 Seconds | Standard Deviation 0.032 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.37 Seconds | Standard Deviation 0.122 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.24 Seconds | Standard Deviation 0.03 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 0.30 Seconds | Standard Deviation 0.03 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.52 Seconds | Standard Deviation 0.148 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.15 Seconds | Standard Deviation 0.031 |
Secondary
Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task
Gait speed was the time taken to walk a specified distance. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | Panoramic Bracelet: Fast Speed | 1.50 Meters per second | Standard Deviation 0.345 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | APDM: Slow Speed | 0.47 Meters per second | Standard Deviation 0.224 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | APDM: Fast Speed | 1.07 Meters per second | Standard Deviation 0.105 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | GAITRite: Fast Speed | 1.41 Meters per second | Standard Deviation 0.234 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | Panoramic Bracelet: Natural Speed | 1.15 Meters per second | Standard Deviation 0.209 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | GAITRite: Slow Speed | 0.59 Meters per second | Standard Deviation 0.256 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | APDM: Natural Speed | 0.89 Meters per second | Standard Deviation 0.147 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | GAITRite: Natural Speed | 1.07 Meters per second | Standard Deviation 0.211 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | Panoramic Bracelet: Slow Speed | 0.77 Meters per second | Standard Deviation 0.298 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | GAITRite: Fast Speed | 1.63 Meters per second | Standard Deviation 0.205 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | Panoramic Bracelet: Natural Speed | 1.24 Meters per second | Standard Deviation 0.228 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | GAITRite: Natural Speed | 1.21 Meters per second | Standard Deviation 0.144 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | APDM: Natural Speed | 1.11 Meters per second | Standard Deviation 0.144 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | Panoramic Bracelet: Fast Speed | 1.57 Meters per second | Standard Deviation 0.191 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | APDM: Fast Speed | 1.45 Meters per second | Standard Deviation 0.13 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | Panoramic Bracelet: Slow Speed | 0.72 Meters per second | Standard Deviation 0.223 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | GAITRite: Slow Speed | 0.70 Meters per second | Standard Deviation 0.28 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | APDM: Slow Speed | 0.61 Meters per second | Standard Deviation 0.273 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | APDM: Natural Speed | 1.13 Meters per second | Standard Deviation 0.12 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | Panoramic Bracelet: Natural Speed | 1.17 Meters per second | Standard Deviation 0.176 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | Panoramic Bracelet: Slow Speed | 0.73 Meters per second | Standard Deviation 0.171 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | GAITRite: Natural Speed | 1.25 Meters per second | Standard Deviation 0.124 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | APDM: Slow Speed | 0.65 Meters per second | Standard Deviation 0.168 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | GAITRite: Fast Speed | 1.59 Meters per second | Standard Deviation 0.225 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | Panoramic Bracelet: Fast Speed | 1.50 Meters per second | Standard Deviation 0.262 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | GAITRite: Slow Speed | 0.76 Meters per second | Standard Deviation 0.174 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task | APDM: Fast Speed | 1.43 Meters per second | Standard Deviation 0.162 |
Secondary
Cohort B: Number of Hours Per Day Wearing the Panoramic Bracelet Devices at Home
Time frame: From Day 1 up to Day 7
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Number of Hours Per Day Wearing the Panoramic Bracelet Devices at Home | 22.65 Hours per day | Standard Deviation 1.051 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Number of Hours Per Day Wearing the Panoramic Bracelet Devices at Home | 22.80 Hours per day | Standard Deviation 1.317 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Number of Hours Per Day Wearing the Panoramic Bracelet Devices at Home | 22.60 Hours per day | Standard Deviation 1.59 |
Secondary
Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Single support time referred to the time when only one limb was in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 0.26 Seconds | Standard Deviation 0.052 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.43 Seconds | Standard Deviation 0.088 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.34 Seconds | Standard Deviation 0.018 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.30 Seconds | Standard Deviation 0.027 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 0.31 Seconds | Standard Deviation 0.111 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.36 Seconds | Standard Deviation 0.079 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.36 Seconds | Standard Deviation 0.021 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.31 Seconds | Standard Deviation 0.016 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 0.50 Seconds | Standard Deviation 0.356 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.32 Seconds | Standard Deviation 0.03 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 0.34 Seconds | Standard Deviation 0.036 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.37 Seconds | Standard Deviation 0.031 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.41 Seconds | Standard Deviation 0.034 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 0.29 Seconds | Standard Deviation 0.029 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.37 Seconds | Standard Deviation 0.031 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 0.48 Seconds | Standard Deviation 0.14 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.46 Seconds | Standard Deviation 0.141 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.52 Seconds | Standard Deviation 0.151 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.45 Seconds | Standard Deviation 0.027 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 0.39 Seconds | Standard Deviation 0.026 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 0.51 Seconds | Standard Deviation 0.102 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.39 Seconds | Standard Deviation 0.027 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.58 Seconds | Standard Deviation 0.112 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.37 Seconds | Standard Deviation 0.025 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 0.35 Seconds | Standard Deviation 0.029 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.50 Seconds | Standard Deviation 0.095 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.42 Seconds | Standard Deviation 0.028 |
Secondary
Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 0.52 Seconds | Standard Deviation 0.1 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.78 Seconds | Standard Deviation 0.256 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.47 Seconds | Standard Deviation 0.037 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.44 Seconds | Standard Deviation 0.063 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 0.61 Seconds | Standard Deviation 0.186 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.74 Seconds | Standard Deviation 0.245 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.52 Seconds | Standard Deviation 0.044 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.52 Seconds | Standard Deviation 0.048 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 0.91 Seconds | Standard Deviation 0.452 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.51 Seconds | Standard Deviation 0.064 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 0.66 Seconds | Standard Deviation 0.062 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.63 Seconds | Standard Deviation 0.064 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.58 Seconds | Standard Deviation 0.061 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 0.55 Seconds | Standard Deviation 0.069 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.48 Seconds | Standard Deviation 0.05 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 0.99 Seconds | Standard Deviation 0.34 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.93 Seconds | Standard Deviation 0.342 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.89 Seconds | Standard Deviation 0.352 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.64 Seconds | Standard Deviation 0.054 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 0.73 Seconds | Standard Deviation 0.055 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 1.03 Seconds | Standard Deviation 0.23 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.71 Seconds | Standard Deviation 0.051 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.95 Seconds | Standard Deviation 0.228 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.62 Seconds | Standard Deviation 0.05 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 0.64 Seconds | Standard Deviation 0.048 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 1.03 Seconds | Standard Deviation 0.232 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.56 Seconds | Standard Deviation 0.044 |
Secondary
Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 0.39 Seconds | Standard Deviation 0.074 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.60 Seconds | Standard Deviation 0.171 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.40 Seconds | Standard Deviation 0.026 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.37 Seconds | Standard Deviation 0.044 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 0.46 Seconds | Standard Deviation 0.152 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.54 Seconds | Standard Deviation 0.157 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.44 Seconds | Standard Deviation 0.024 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.42 Seconds | Standard Deviation 0.03 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 0.70 Seconds | Standard Deviation 0.418 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.42 Seconds | Standard Deviation 0.047 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 0.50 Seconds | Standard Deviation 0.046 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.49 Seconds | Standard Deviation 0.044 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.50 Seconds | Standard Deviation 0.046 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 0.42 Seconds | Standard Deviation 0.042 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.43 Seconds | Standard Deviation 0.042 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 0.74 Seconds | Standard Deviation 0.241 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.70 Seconds | Standard Deviation 0.229 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.71 Seconds | Standard Deviation 0.247 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.55 Seconds | Standard Deviation 0.037 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 0.55 Seconds | Standard Deviation 0.037 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 0.77 Seconds | Standard Deviation 0.164 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.55 Seconds | Standard Deviation 0.037 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.76 Seconds | Standard Deviation 0.162 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.49 Seconds | Standard Deviation 0.036 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 0.50 Seconds | Standard Deviation 0.038 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.76 Seconds | Standard Deviation 0.165 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.49 Seconds | Standard Deviation 0.033 |
Secondary
Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Stride duration refers to the duration between successive heel contacts of the same foot. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 1.20 Seconds | Standard Deviation 0.336 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 0.90 Seconds | Standard Deviation 0.257 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.84 Seconds | Standard Deviation 0.07 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.88 Seconds | Standard Deviation 0.055 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 0.78 Seconds | Standard Deviation 0.14 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.73 Seconds | Standard Deviation 0.085 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.82 Seconds | Standard Deviation 0.063 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 1.24 Seconds | Standard Deviation 0.552 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 1.12 Seconds | Standard Deviation 0.352 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.83 Seconds | Standard Deviation 0.094 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 1.42 Seconds | Standard Deviation 0.489 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 1.00 Seconds | Standard Deviation 0.093 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 0.84 Seconds | Standard Deviation 0.093 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 1.46 Seconds | Standard Deviation 0.477 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.99 Seconds | Standard Deviation 0.091 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 1.40 Seconds | Standard Deviation 0.473 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.85 Seconds | Standard Deviation 0.079 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.99 Seconds | Standard Deviation 0.093 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.98 Seconds | Standard Deviation 0.069 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 1.52 Seconds | Standard Deviation 0.33 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 0.99 Seconds | Standard Deviation 0.075 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.98 Seconds | Standard Deviation 0.071 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 1.52 Seconds | Standard Deviation 0.33 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 1.09 Seconds | Standard Deviation 0.074 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 1.11 Seconds | Standard Deviation 0.078 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 1.10 Seconds | Standard Deviation 0.073 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 1.53 Seconds | Standard Deviation 0.326 |
Secondary
Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 1.17 Meters | Standard Deviation 0.32 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.51 Meters | Standard Deviation 0.157 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.88 Meters | Standard Deviation 0.073 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 1.02 Meters | Standard Deviation 0.101 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 1.01 Meters | Standard Deviation 0.182 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.61 Meters | Standard Deviation 0.174 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.78 Meters | Standard Deviation 0.104 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.88 Meters | Standard Deviation 0.122 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 0.85 Meters | Standard Deviation 0.211 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 1.34 Meters | Standard Deviation 0.106 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 1.24 Meters | Standard Deviation 0.166 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 1.20 Meters | Standard Deviation 0.093 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 1.09 Meters | Standard Deviation 0.091 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 1.33 Meters | Standard Deviation 0.163 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 1.23 Meters | Standard Deviation 0.109 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 0.99 Meters | Standard Deviation 0.244 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.90 Meters | Standard Deviation 0.217 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.78 Meters | Standard Deviation 0.194 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 1.23 Meters | Standard Deviation 0.093 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 1.29 Meters | Standard Deviation 0.149 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 1.06 Meters | Standard Deviation 0.127 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 1.37 Meters | Standard Deviation 0.094 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.94 Meters | Standard Deviation 0.112 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 1.56 Meters | Standard Deviation 0.159 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 1.48 Meters | Standard Deviation 0.197 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 1.11 Meters | Standard Deviation 0.122 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 1.39 Meters | Standard Deviation 0.12 |
Secondary
Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Swing time was defined as the time during which the foot was not in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace (Walk slow) and fast pace (Walk fast) for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.
Time frame: Up to 20 minutes on Day 1
Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Participants Aged 3-5 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 0.39 Seconds | Standard Deviation 0.182 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 0.26 Seconds | Standard Deviation 0.051 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.32 Seconds | Standard Deviation 0.016 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.34 Seconds | Standard Deviation 0.017 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.30 Seconds | Standard Deviation 0.026 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 0.30 Seconds | Standard Deviation 0.085 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.36 Seconds | Standard Deviation 0.081 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.36 Seconds | Standard Deviation 0.015 |
| Cohort A: Participants Aged 3-5 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.43 Seconds | Standard Deviation 0.087 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 0.48 Seconds | Standard Deviation 0.137 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 0.34 Seconds | Standard Deviation 0.036 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.37 Seconds | Standard Deviation 0.032 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.41 Seconds | Standard Deviation 0.034 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 0.29 Seconds | Standard Deviation 0.029 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.33 Seconds | Standard Deviation 0.029 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.37 Seconds | Standard Deviation 0.031 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.46 Seconds | Standard Deviation 0.139 |
| Cohort A: Participants Aged 6-11 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.52 Seconds | Standard Deviation 0.14 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Fast Speed | 0.42 Seconds | Standard Deviation 0.026 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Natural Speed | 0.45 Seconds | Standard Deviation 0.027 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Slow Speed | 0.51 Seconds | Standard Deviation 0.102 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Natural Speed | 0.39 Seconds | Standard Deviation 0.026 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | APDM: Slow Speed | 0.57 Seconds | Standard Deviation 0.109 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Slow Speed | 0.50 Seconds | Standard Deviation 0.095 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | GAITRite: Fast Speed | 0.37 Seconds | Standard Deviation 0.026 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Fast Speed | 0.34 Seconds | Standard Deviation 0.029 |
| Cohort A: Participants Aged 12-17 Years | Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks | Panoramic Bracelet: Natural Speed | 0.38 Seconds | Standard Deviation 0.026 |