Parkinson Disease
Conditions
Keywords
Parkinson disease, rhythmic auditory stimulation, digital therapeutics, behavior change, habits, physical activity
Brief summary
Regular, habitual exercise is a critical component of the long-term management of Parkinson disease (PD). However, PD-specific motor (e.g. slow and diminished movements, variable step timing) and non-motor (e.g. depression, apathy) problems collectively hinder physical activity. Rhythmic auditory stimulation (RAS) is a rehabilitation technique that employs coupling of auditory cues with movement. Walking with RAS has been shown to benefit walking rhythmicity, quality, and speed. These walking benefits make RAS advantageous in promoting moderate intensity walking activity -- an important health-objective in the management of PD. However, the therapeutic potential of RAS in self-directed walking programs has not been examined. In this pilot, we will utilize a breakthrough digital therapeutic that delivers music-adaptive RAS to alleviate PD-specific problems by regulating stepping patterns. Using music as a substrate for cue delivery, this digital therapeutic leverages gait benefits from RAS along with enjoyment of music listening, thus making it a viable and engaging modality that will yield habits of regular walking. Habits are automatically recurring psychological dispositions that emerge from repeated behaviors. The investigators posit that music cues provide recurring contextual cues that automatically evoke habitual response of exercise, thus has the potential to prompt regular physical activity. This study will enroll 61individuals with mild-to-moderate PD (Run-in: 17; Main Trial: 44). The experimental intervention, Amped-PD, is a 6-week, user-managed community-based walking program that utilizes music-adaptive RAS that progressively increases walking intensities. This study will examine if Amped-PD (Experimental Intervention) is more effective than a standard-of-care walking program (Active-Control Intervention) in improving physical activity based on moderate intensity walking, and in improving motor deficits related to quality of walking in individuals with mild-to-moderate PD. This study will also examine whether the resultant habits formed from each intervention matter in relation to training-related changes in physical activity.
Detailed description
Parkinson disease (PD) is the fastest growing source of disability among neurological disorders. Diminished physical activity is highly prevalent in PD and often lead to the onset of disability. Regular, habitual exercise is a critical component of the long-term PD management. However, PD-specific motor (e.g. slow and diminished movements, variable step timing) and non-motor (e.g. depression, apathy) problems collectively hinder physical activity. Rhythmic auditory stimulation (RAS) is a rehabilitation technique that employs the coupling of auditory cues with movement. When used during walking, RAS has been shown to benefit walking rhythmicity, quality, and speed. Therefore this rehabilitation technique can be advantageous in promoting moderate intensity walking activity. While clinical studies support RAS-based intervention, its translation to real-world, community-based environments and for long-term exercise for the promotion of physical activity is limited. The difference that determines viability of RAS for out-of-lab applications lie in the distinction between external entrainment (open-loop) versus autonomous entrainment (closed-loop). Open-loop RAS requires high levels of vigilance and is prone to error accumulation, which is problematic with gait dysfunction in PD. On the other hand, closed-loop RAS allows for natural and stable entrainment. A closed-loop approach in this case is a necessity of the task and a technological challenge to translate RAS to community-based settings. In this pilot, the investigators will utilize a breakthrough digital therapeutic that employs closed-loop RAS to alleviate PD-specific problems by regulating stepping patterns. Using music as a substrate for cue delivery, this digital therapeutic leverages gait benefits from RAS along with enjoyment of music listening, thus making it a viable and engaging modality that will yield habits of regular walking. The investigators posit that music that is linked to enjoyment serves as context cues that define the pre-condition to engaging in habitual walking exercise and increased physical activity. With repetition, these recurring contextual triggers (i.e. music) automatically evoke a habitual response of exercise, and thus has the potential to amplify physical activity. The main aims of the study seek to examine if Amped-PD (Experimental Intervention) is more effective than a standard-of-care walking program (Active-Control Intervention) in improving physical activity based on moderate intensity walking (Aim 1), and in improving motor deficits related to quality of walking (Aim 2) in individuals with mild-to-moderate PD. Additionally, this study will examine whether habit formation mediates the relationship between the intervention (Amped-PD or Active-Control) and physical activity (Aim 3). The investigators hypothesize that Amped-PD will have greater improvements in amounts of moderate intensity walking and stride-to-stride variability based on stride length and swing time. Further, habit formation will be one mechanism that will explain the link between the intervention and physical activity. Secondary research aims will examine whether Amped-PD is more effective than Active-Control in improving motor and non-motor features based on short- and long-distance walking function, spatiotemporal measures of walking, step activity based on daily step counts, disease severity scores, quality of life, self-efficacy on walking, and depression. This study will utilize the breakthrough digital music therapeutic developed and manufactured by MedRhythms (Portland, ME). To examine the effects of the intervention, the investigators will use clinical measures of motor and gait function, participant self-reports on habit formation, and quantified movement data on walking and physical activity using wearable sensors. This study will be implemented by carrying out the following study visits: (1) Primary screen over the phone, (2) Clinical Screening and Baseline Assessment, (3) Community-based, self-directed walking program (6 weeks), (3) Post-training Assessment; (4) Follow-up training (2 weeks), and (5) Final Follow-Up Assessment. Altogether, these procedures may take up to 10 weeks.
Interventions
DEVICEDigital music therapeutic
The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
BEHAVIORALActive-Control
The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
Sponsors
University of New England
National Institute on Aging (NIA)
Boston University Charles River Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants are randomly assigned to either intervention of (1) Amped-PD, or (2) Active-Control.
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of idiopathic, typical Parkinson disease (based on the UK PD Society Brain Bank Criteria7) by a physician * Modified Hoehn and Yahr stages 1-3 per physical exam by a licensed physical therapist * 40 - 85 years of age * Community-dwelling * Able to walk independently without physical assistance or an assistive device for at least 10 minutes. * Have stable PD medications for at least two weeks prior to enrollment. * Willing and able to provide informed consent. * Provide HIPAA Authorization to allow communication with the primary healthcare provider for communication (as needed) during the study period.
Exclusion criteria
* \< 40 years of age * Diagnosis of atypical Parkinsonism * Modified Hoehn and Yahr stages 4-5 * Moderately or significantly disturbing freezing episodes during daily walking based on the New Freezing of Gait Questionnaire * History of \>1 fall over the past 3 months * Cognitive impairment (i.e., Mini-Mental State Exam Score (MMSE) \< 24) * Unable to walk independently (i.e. without physical assistance or assistive device) at a comfortable speed of 0.4m/s or greater (i.e., 10-meter Walk Test (10mWT)) * Unable to independently use the music-based digital therapeutic during training * Significant hearing impairment * Currently participating in physical therapy * Currently performing regular walking exercise \> 3x/week for 30 minutes per session. * Cardiac conditions that may limit safe participation in exercise * Orthopedic conditions that may limit safe participation in exercise * Any other medical conditions that would preclude successful participation as determined by a physical therapist
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Based on the Amount of Moderate Intensity Walking | Baseline | The amount of moderate intensity walking, defined as mean number of minutes per day with \>100 steps/min. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD. |
| Step Activity Based on Daily Step Counts | Baseline | Daily step counts refer to the total number of steps taken on the leg with the monitor. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD. |
| Gait Quality Based on Variability of Stride Time | Baseline | Stride-to-stride variability of stride time of the gait cycle will be measured using wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as percentage. Worse gait quality is indicated by higher stride time variability, while improved gait quality is indicated by lower stride time variability. |
| Self-Report Habit Index (SRHI) | Baseline | The Self-Report Habit Index (SRHI) will be used to assess habit formation. This index is a patient-reported outcome that examines habit strength. This self-report index comprises of 12 statements with constructs spanning behavior repetition, automaticity, and identity, with responses made on 11-point Likert scales (0 = strongly disagree; 10 = strongly agree). Higher scores indicate stronger habit formation (min = 0, max = 100). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait Velocity During In-clinic Walking | Baseline | Quantified metrics of walking velocity (m/s) will be collected using wearable sensors. |
| Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III) | Baseline | The MDS UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination (33 scores summed from 18 questions) conducted by the rater. The total score is reported, which can range from 0 (no impairment) to 141 (maximum impairment). |
| Self-Efficacy of Walking - Duration (SEW-D) | Baseline | The SEW-D is a 10-item self-report that will be administered to determine participants' beliefs of their physical capabilities to successfully complete incremental 5-minute intervals (5 to 40 minutes) of walking at a moderately fast pace, with responses made on 11-point Likert scale (0% = not at all confident; 100% = highly confident). |
| 10-Meter Walk Test (10MWT) - Comfortable Walking Speed | Baseline | This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) on a ten-meter straight walkway. Two trials will be administered, and the average of two trials will be reported. |
| Parkinson's Disease Questionnaire - 39 (PDQ-39) | Baseline | The PDQ- 39 is a self-report questionnaire that assesses quality of life over the past month across 8 different dimensions. Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life. Lower scores reflect better quality of life (min = 0, max = 100). |
| Mini Balance Evaluation Systems Test (Mini BESTest) | Baseline | This test comprises of 14 items that span anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is scored from 0-2 (0 = lowest level of function, 2 = highest level of function). The total score is reported, calculated as the sum of all items, with possible scores of 0 (lowest level of balance function) and a maximum score of 28 (highest level of balance function). |
| Geriatric Depression Scale (GDS) | Baseline | The GDS is a brief, self-report involving yes/no questions instrument on psychological aspects and social consequences of depression in the elderly. The short form of GDS of 15-items will be used in this study. Higher scores indicate greater depression (min = 0, max = 15). |
| 10-Meter Walk Test (10MWT) - Maximum Walking Speed | Baseline | This is a test of short-distance walking function. The participant will be asked to walk at maximum walking speed (MWS) on a ten-meter straight walkway. Two trials will be administered, and the average of two trials will be reported. |
| 6-Minute Walk Test (6MWT) | Baseline | This is test of long-distance walking function. The participant will be asked to cover as much distance as they safely can for 6 minutes, and total distance is the main metric from this test. |
| Stride Length During In-clinic Walking | Baseline | Quantified metrics of stride length (m) will be collected using wearable sensors. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Amped-PD 6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics. | 21 |
| Active-Control 6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic. | 20 |
| Total | 41 |
Baseline characteristics
| Characteristic | Amped-PD | Active-Control | Total |
|---|---|---|---|
| Age, Continuous | 66.95 years STANDARD_DEVIATION 8.84 | 60.065 years STANDARD_DEVIATION 9.13 | 63.87 years STANDARD_DEVIATION 9.42 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 19 Participants | 40 Participants |
| Region of Enrollment United States | 21 participants | 20 participants | 41 participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
| Unified Parkinson's Disease Rating Scale Part III Score | 20.71 Points STANDARD_DEVIATION 7.68 | 22.75 Points STANDARD_DEVIATION 10.6 | 20.73 Points STANDARD_DEVIATION 8.57 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 20 |
| other Total, other adverse events | 4 / 21 | 6 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
Primary
Gait Quality Based on Variability of Stride Time
Stride-to-stride variability of stride time of the gait cycle will be measured using wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as percentage. Worse gait quality is indicated by higher stride time variability, while improved gait quality is indicated by lower stride time variability.
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Gait Quality Based on Variability of Stride Time | 3.70 %coefficient of variation | Standard Deviation 2.01 |
| Active-Control | Gait Quality Based on Variability of Stride Time | 3.05 %coefficient of variation | Standard Deviation 1.7 |
Primary
Gait Quality Based on Variability of Stride Time
Stride-to-stride variability of stride time of the gait cycle will be measured using wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as percentage. Worse gait quality is indicated by higher stride time variability, while improved gait quality is indicated by lower stride time variability.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Gait Quality Based on Variability of Stride Time | 4.19 %coefficient of variation | Standard Deviation 2.38 |
| Active-Control | Gait Quality Based on Variability of Stride Time | 2.88 %coefficient of variation | Standard Deviation 0.81 |
Primary
Gait Quality Based on Variability of Stride Time
Stride-to-stride variability of stride time of the gait cycle will be measured using wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as percentage. Worse gait quality is indicated by higher stride time variability, while improved gait quality is indicated by lower stride time variability.
Time frame: Immediately after the intervention (up to 6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Gait Quality Based on Variability of Stride Time | 3.46 %coefficient of variation | Standard Deviation 1.64 |
| Active-Control | Gait Quality Based on Variability of Stride Time | 3.18 %coefficient of variation | Standard Deviation 1.07 |
Primary
Physical Activity Based on the Amount of Moderate Intensity Walking
The amount of moderate intensity walking, defined as mean number of minutes per day with \>100 steps/min. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Time frame: During training up to 4 days from start of training
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Physical Activity Based on the Amount of Moderate Intensity Walking | 32.83 minutes of moderate intensity walking | Standard Deviation 10.14 |
| Active-Control | Physical Activity Based on the Amount of Moderate Intensity Walking | 23.08 minutes of moderate intensity walking | Standard Deviation 12.09 |
Primary
Physical Activity Based on the Amount of Moderate Intensity Walking
The amount of moderate intensity walking, defined as mean number of minutes per day with \>100 steps/min. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Time frame: Immediately after the intervention (up to 6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Physical Activity Based on the Amount of Moderate Intensity Walking | 30.30 minutes of moderate intensity walking | Standard Deviation 11.45 |
| Active-Control | Physical Activity Based on the Amount of Moderate Intensity Walking | 24.15 minutes of moderate intensity walking | Standard Deviation 15.23 |
Primary
Physical Activity Based on the Amount of Moderate Intensity Walking
The amount of moderate intensity walking, defined as mean number of minutes per day with \>100 steps/min. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Time frame: Follow-up (up to 2 weeks post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Physical Activity Based on the Amount of Moderate Intensity Walking | 6.85 minutes of moderate intensity walking | Standard Deviation 6.48 |
| Active-Control | Physical Activity Based on the Amount of Moderate Intensity Walking | 13.22 minutes of moderate intensity walking | Standard Deviation 9.62 |
Primary
Physical Activity Based on the Amount of Moderate Intensity Walking
The amount of moderate intensity walking, defined as mean number of minutes per day with \>100 steps/min. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Physical Activity Based on the Amount of Moderate Intensity Walking | 9.45 minutes of moderate intensity walking | Standard Deviation 9.39 |
| Active-Control | Physical Activity Based on the Amount of Moderate Intensity Walking | 16.17 minutes of moderate intensity walking | Standard Deviation 18.08 |
Primary
Self-Report Habit Index (SRHI)
The Self-Report Habit Index (SRHI) will be used to assess habit formation. This index is a patient-reported outcome that examines habit strength. This self-report index comprises of 12 statements with constructs spanning behavior repetition, automaticity, and identity, with responses made on 11-point Likert scales (0 = strongly disagree; 10 = strongly agree). Higher scores indicate stronger habit formation (min = 0, max = 100).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Self-Report Habit Index (SRHI) | 59.40 percent (out of 100%) | Standard Deviation 26.57 |
| Active-Control | Self-Report Habit Index (SRHI) | 44.08 percent (out of 100%) | Standard Deviation 29.79 |
Primary
Self-Report Habit Index (SRHI)
The Self-Report Habit Index (SRHI) will be used to assess habit formation. This index is a patient-reported outcome that examines habit strength. This self-report index comprises of 12 statements with constructs spanning behavior repetition, automaticity, and identity, with responses made on 11-point Likert scales (0 = strongly disagree; 10 = strongly agree). Higher scores indicate stronger habit formation (min = 0, max = 100).
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Self-Report Habit Index (SRHI) | 74.25 percent (out of 100%) | Standard Deviation 20.72 |
| Active-Control | Self-Report Habit Index (SRHI) | 57.85 percent (out of 100%) | Standard Deviation 24.68 |
Primary
Step Activity Based on Daily Step Counts
Daily step counts refer to the total number of steps taken on the leg with the monitor. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Time frame: Immediately after the intervention (up to 6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Step Activity Based on Daily Step Counts | 11346 steps | Standard Deviation 2665 |
| Active-Control | Step Activity Based on Daily Step Counts | 10926 steps | Standard Deviation 2756 |
Primary
Step Activity Based on Daily Step Counts
Daily step counts refer to the total number of steps taken on the leg with the monitor. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Step Activity Based on Daily Step Counts | 8812 steps | Standard Deviation 3453 |
| Active-Control | Step Activity Based on Daily Step Counts | 10311 steps | Standard Deviation 3497 |
Primary
Step Activity Based on Daily Step Counts
Daily step counts refer to the total number of steps taken on the leg with the monitor. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Time frame: During training up to 4 days from start of training
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Step Activity Based on Daily Step Counts | 12155 steps | Standard Deviation 3127 |
| Active-Control | Step Activity Based on Daily Step Counts | 10483 steps | Standard Deviation 3751 |
Primary
Step Activity Based on Daily Step Counts
Daily step counts refer to the total number of steps taken on the leg with the monitor. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Step Activity Based on Daily Step Counts | 8407 steps | Standard Deviation 2967 |
| Active-Control | Step Activity Based on Daily Step Counts | 8284 steps | Standard Deviation 3933 |
Secondary
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) on a ten-meter straight walkway. Two trials will be administered, and the average of two trials will be reported.
Time frame: Immediately after the intervention (up to 6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | 10-Meter Walk Test (10MWT) - Comfortable Walking Speed | 1.18 m/s | Standard Deviation 0.16 |
| Active-Control | 10-Meter Walk Test (10MWT) - Comfortable Walking Speed | 1.32 m/s | Standard Deviation 0.15 |
Secondary
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) on a ten-meter straight walkway. Two trials will be administered, and the average of two trials will be reported.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | 10-Meter Walk Test (10MWT) - Comfortable Walking Speed | 1.16 m/s | Standard Deviation 0.15 |
| Active-Control | 10-Meter Walk Test (10MWT) - Comfortable Walking Speed | 1.27 m/s | Standard Deviation 0.16 |
Secondary
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) on a ten-meter straight walkway. Two trials will be administered, and the average of two trials will be reported.
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | 10-Meter Walk Test (10MWT) - Comfortable Walking Speed | 1.18 m/s | Standard Deviation 0.14 |
| Active-Control | 10-Meter Walk Test (10MWT) - Comfortable Walking Speed | 1.36 m/s | Standard Deviation 0.16 |
Secondary
10-Meter Walk Test (10MWT) - Maximum Walking Speed
This is a test of short-distance walking function. The participant will be asked to walk at maximum walking speed (MWS) on a ten-meter straight walkway. Two trials will be administered, and the average of two trials will be reported.
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | 10-Meter Walk Test (10MWT) - Maximum Walking Speed | 1.80 m/s | Standard Deviation 0.36 |
| Active-Control | 10-Meter Walk Test (10MWT) - Maximum Walking Speed | 1.80 m/s | Standard Deviation 0.26 |
Secondary
10-Meter Walk Test (10MWT) - Maximum Walking Speed
This is a test of short-distance walking function. The participant will be asked to walk at maximum walking speed (MWS) on a ten-meter straight walkway. Two trials will be administered, and the average of two trials will be reported.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | 10-Meter Walk Test (10MWT) - Maximum Walking Speed | 1.74 m/s | Standard Deviation 0.36 |
| Active-Control | 10-Meter Walk Test (10MWT) - Maximum Walking Speed | 1.82 m/s | Standard Deviation 0.26 |
Secondary
10-Meter Walk Test (10MWT) - Maximum Walking Speed
This is a test of short-distance walking function. The participant will be asked to walk at maximum walking speed (MWS) on a ten-meter straight walkway. Two trials will be administered, and the average of two trials will be reported.
Time frame: Immediately after the intervention (up to 6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | 10-Meter Walk Test (10MWT) - Maximum Walking Speed | 1.77 m/s | Standard Deviation 0.37 |
| Active-Control | 10-Meter Walk Test (10MWT) - Maximum Walking Speed | 1.83 m/s | Standard Deviation 0.32 |
Secondary
6-Minute Walk Test (6MWT)
This is test of long-distance walking function. The participant will be asked to cover as much distance as they safely can for 6 minutes, and total distance is the main metric from this test.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | 6-Minute Walk Test (6MWT) | 520.32 m | Standard Deviation 86.99 |
| Active-Control | 6-Minute Walk Test (6MWT) | 548.56 m | Standard Deviation 79.93 |
Secondary
6-Minute Walk Test (6MWT)
This is test of long-distance walking function. The participant will be asked to cover as much distance as they safely can for 6 minutes, and total distance is the main metric from this test.
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | 6-Minute Walk Test (6MWT) | 533.31 m | Standard Deviation 92.65 |
| Active-Control | 6-Minute Walk Test (6MWT) | 570.98 m | Standard Deviation 83.06 |
Secondary
6-Minute Walk Test (6MWT)
This is test of long-distance walking function. The participant will be asked to cover as much distance as they safely can for 6 minutes, and total distance is the main metric from this test.
Time frame: Immediately after the intervention (up to 6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | 6-Minute Walk Test (6MWT) | 524.56 m | Standard Deviation 83.56 |
| Active-Control | 6-Minute Walk Test (6MWT) | 562.31 m | Standard Deviation 84.79 |
Secondary
Gait Velocity During In-clinic Walking
Quantified metrics of walking velocity (m/s) will be collected using wearable sensors.
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Gait Velocity During In-clinic Walking | 1.55 m/s | Standard Deviation 0.26 |
| Active-Control | Gait Velocity During In-clinic Walking | 1.63 m/s | Standard Deviation 0.25 |
Secondary
Gait Velocity During In-clinic Walking
Quantified metrics of walking velocity (m/s) will be collected using wearable sensors.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Gait Velocity During In-clinic Walking | 1.50 m/s | Standard Deviation 0.26 |
| Active-Control | Gait Velocity During In-clinic Walking | 1.58 m/s | Standard Deviation 0.22 |
Secondary
Gait Velocity During In-clinic Walking
Quantified metrics of walking velocity (m/s) will be collected using wearable sensors.
Time frame: Immediately after the intervention (up to 6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Gait Velocity During In-clinic Walking | 1.53 m/s | Standard Deviation 0.25 |
| Active-Control | Gait Velocity During In-clinic Walking | 1.63 m/s | Standard Deviation 0.25 |
Secondary
Geriatric Depression Scale (GDS)
The GDS is a brief, self-report involving yes/no questions instrument on psychological aspects and social consequences of depression in the elderly. The short form of GDS of 15-items will be used in this study. Higher scores indicate greater depression (min = 0, max = 15).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Geriatric Depression Scale (GDS) | 2 points | Standard Deviation 2.19 |
| Active-Control | Geriatric Depression Scale (GDS) | 2.42 points | Standard Deviation 2.34 |
Secondary
Geriatric Depression Scale (GDS)
The GDS is a brief, self-report involving yes/no questions instrument on psychological aspects and social consequences of depression in the elderly. The short form of GDS of 15-items will be used in this study. Higher scores indicate greater depression (min = 0, max = 15).
Time frame: Immediately after the intervention (up to 6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Geriatric Depression Scale (GDS) | 2.24 points | Standard Deviation 2.7 |
| Active-Control | Geriatric Depression Scale (GDS) | 2.16 points | Standard Deviation 2.09 |
Secondary
Geriatric Depression Scale (GDS)
The GDS is a brief, self-report involving yes/no questions instrument on psychological aspects and social consequences of depression in the elderly. The short form of GDS of 15-items will be used in this study. Higher scores indicate greater depression (min = 0, max = 15).
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Geriatric Depression Scale (GDS) | 2.76 points | Standard Deviation 1.7 |
| Active-Control | Geriatric Depression Scale (GDS) | 2.53 points | Standard Deviation 1.54 |
Secondary
Mini Balance Evaluation Systems Test (Mini BESTest)
This test comprises of 14 items that span anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is scored from 0-2 (0 = lowest level of function, 2 = highest level of function). The total score is reported, calculated as the sum of all items, with possible scores of 0 (lowest level of balance function) and a maximum score of 28 (highest level of balance function).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Mini Balance Evaluation Systems Test (Mini BESTest) | 24.24 points | Standard Deviation 2.43 |
| Active-Control | Mini Balance Evaluation Systems Test (Mini BESTest) | 24.89 points | Standard Deviation 2.66 |
Secondary
Mini Balance Evaluation Systems Test (Mini BESTest)
This test comprises of 14 items that span anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is scored from 0-2 (0 = lowest level of function, 2 = highest level of function). The total score is reported, calculated as the sum of all items, with possible scores of 0 (lowest level of balance function) and a maximum score of 28 (highest level of balance function).
Time frame: Immediately after the intervention (up to 6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Mini Balance Evaluation Systems Test (Mini BESTest) | 24.43 points | Standard Deviation 2.09 |
| Active-Control | Mini Balance Evaluation Systems Test (Mini BESTest) | 25.84 points | Standard Deviation 1.53 |
Secondary
Mini Balance Evaluation Systems Test (Mini BESTest)
This test comprises of 14 items that span anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is scored from 0-2 (0 = lowest level of function, 2 = highest level of function). The total score is reported, calculated as the sum of all items, with possible scores of 0 (lowest level of balance function) and a maximum score of 28 (highest level of balance function).
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Mini Balance Evaluation Systems Test (Mini BESTest) | 24.86 points | Standard Deviation 2.03 |
| Active-Control | Mini Balance Evaluation Systems Test (Mini BESTest) | 26.00 points | Standard Deviation 1.53 |
Secondary
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III)
The MDS UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination (33 scores summed from 18 questions) conducted by the rater. The total score is reported, which can range from 0 (no impairment) to 141 (maximum impairment).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III) | 20.71 points | Standard Deviation 7.68 |
| Active-Control | Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III) | 22.75 points | Standard Deviation 10.6 |
Secondary
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III)
The MDS UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination (33 scores summed from 18 questions) conducted by the rater. The total score is reported, which can range from 0 (no impairment) to 141 (maximum impairment).
Time frame: Immediately after the intervention (up to 6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III) | 23.48 points | Standard Deviation 9.41 |
| Active-Control | Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III) | 21.11 points | Standard Deviation 18.74 |
Secondary
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III)
The MDS UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination (33 scores summed from 18 questions) conducted by the rater. The total score is reported, which can range from 0 (no impairment) to 141 (maximum impairment).
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III) | 22.86 points | Standard Deviation 10.15 |
| Active-Control | Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III) | 18.74 points | Standard Deviation 7.65 |
Secondary
Parkinson's Disease Questionnaire - 39 (PDQ-39)
The PDQ- 39 is a self-report questionnaire that assesses quality of life over the past month across 8 different dimensions. Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life. Lower scores reflect better quality of life (min = 0, max = 100).
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Parkinson's Disease Questionnaire - 39 (PDQ-39) | 12.34 points | Standard Deviation 8.23 |
| Active-Control | Parkinson's Disease Questionnaire - 39 (PDQ-39) | 14.61 points | Standard Deviation 9.23 |
Secondary
Parkinson's Disease Questionnaire - 39 (PDQ-39)
The PDQ- 39 is a self-report questionnaire that assesses quality of life over the past month across 8 different dimensions. Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life. Lower scores reflect better quality of life (min = 0, max = 100).
Time frame: Immediately after the intervention (up to 6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Parkinson's Disease Questionnaire - 39 (PDQ-39) | 13.57 points | Standard Deviation 8.92 |
| Active-Control | Parkinson's Disease Questionnaire - 39 (PDQ-39) | 15.44 points | Standard Deviation 8.1 |
Secondary
Parkinson's Disease Questionnaire - 39 (PDQ-39)
The PDQ- 39 is a self-report questionnaire that assesses quality of life over the past month across 8 different dimensions. Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life. Lower scores reflect better quality of life (min = 0, max = 100).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Parkinson's Disease Questionnaire - 39 (PDQ-39) | 11.95 points | Standard Deviation 8.24 |
| Active-Control | Parkinson's Disease Questionnaire - 39 (PDQ-39) | 14.36 points | Standard Deviation 8.46 |
Secondary
Self-Efficacy of Walking - Duration (SEW-D)
The SEW-D is a 10-item self-report that will be administered to determine participants' beliefs of their physical capabilities to successfully complete incremental 5-minute intervals (5 to 40 minutes) of walking at a moderately fast pace, with responses made on 11-point Likert scale (0% = not at all confident; 100% = highly confident).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Self-Efficacy of Walking - Duration (SEW-D) | 73.76 percent | Standard Deviation 18.85 |
| Active-Control | Self-Efficacy of Walking - Duration (SEW-D) | 69.89 percent | Standard Deviation 18.83 |
Secondary
Self-Efficacy of Walking - Duration (SEW-D)
The SEW-D is a 10-item self-report that will be administered to determine participants' beliefs of their physical capabilities to successfully complete incremental 5-minute intervals (5 to 40 minutes) of walking at a moderately fast pace, with responses made on 11-point Likert scale (0% = not at all confident; 100% = highly confident).
Time frame: Immediately after the intervention (up to 6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Self-Efficacy of Walking - Duration (SEW-D) | 78.14 percent | Standard Deviation 19.49 |
| Active-Control | Self-Efficacy of Walking - Duration (SEW-D) | 76.95 percent | Standard Deviation 15.39 |
Secondary
Self-Efficacy of Walking - Duration (SEW-D)
The SEW-D is a 10-item self-report that will be administered to determine participants' beliefs of their physical capabilities to successfully complete incremental 5-minute intervals (5 to 40 minutes) of walking at a moderately fast pace, with responses made on 11-point Likert scale (0% = not at all confident; 100% = highly confident).
Time frame: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Self-Efficacy of Walking - Duration (SEW-D) | 78.57 percent | Standard Deviation 19.51 |
| Active-Control | Self-Efficacy of Walking - Duration (SEW-D) | 76.89 percent | Standard Deviation 19.48 |
Secondary
Stride Length During In-clinic Walking
Quantified metrics of stride length (m) will be collected using wearable sensors.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Stride Length During In-clinic Walking | 1.49 m | Standard Deviation 0.18 |
| Active-Control | Stride Length During In-clinic Walking | 1.54 m | Standard Deviation 0.24 |
Secondary
Stride Length During In-clinic Walking
Quantified metrics of stride length (m) will be collected using wearable sensors.
Time frame: Immediately after the intervention (up to 6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Stride Length During In-clinic Walking | 1.52 m | Standard Deviation 0.2 |
| Active-Control | Stride Length During In-clinic Walking | 1.56 m | Standard Deviation 0.28 |
Secondary
Stride Length During In-clinic Walking
Quantified metrics of stride length (m) will be collected using wearable sensors.
Time frame: Follow-up (up to 2 weeks post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amped-PD | Stride Length During In-clinic Walking | 1.53 m | Standard Deviation 0.2 |
| Active-Control | Stride Length During In-clinic Walking | 1.56 m | Standard Deviation 0.25 |