Foot Injuries and Disorders
Conditions
Keywords
Ankle Foot Orthoses, Carbon Fiber, Gait, Adult, Biomechanics, Materials Testing, Physical Performance
Brief summary
The proposed effort is designed to support evidence-based practice and optimal care by evaluating how the form, fit and function of two commercially available carbon fiber custom fit braces (Orthoses) influences outcomes following extremity injury. Early data suggests that custom fit carbon fiber braces can significantly improve function following severe lower leg injuries. The proposed study will provide evidence that can be used by clinicians to guide their practice, including care for service members, veterans and civilians who have experienced a high-energy traumatic injury to their lower leg.
Detailed description
In this research study, adult participants who have sustained a below-the-knee traumatic injury greater than two years ago and are still experiencing deficits including weakness and/or immobility will be assigned to one of two brace sequences (AB or BA). Participants will be randomized to a particular sequence, with an equal chance of getting either order. Participants will be evaluated under 4 conditions: no device, standard of care, and 2 carbon fiber custom dynamic orthoses (CDO), the Reaktiv device from FabTech Systems and the PhatBrace by Bio-Mechanical Composites Inc. Participants will be tested with no device and standard of care at baseline, after 3 months of accommodation to the Reaktiv, and 3 months of accommodation to the PhatBrace. A series of study measures will be performed. The physical performance measures will incorporate tests of agility, balance, speed and lower limb power. Questionnaires will be used to evaluate participant's perceived comfort and smoothness, pain, preference, and semi-structured interviews will be used to fully capture the perspective of the participant. A motion capture system will be used to evaluate walking mechanics, allowing comparisons between conditions. Lower limb forces and body motion will be assessed using computerized motion capture and force plates in the floor, as individuals walk over-ground. Small reflective markers placed on the participant's skin and force measuring plates in the floor will be used. The investigators will also complete mechanical testing of the devices and collect demographic and descriptive data.
Interventions
DEVICEReaktiv AFO
This device is a carbon fiber ankle foot orthosis (brace) that contacts the foot and lower leg. It consists of a foot plate that is designed to protect the foot, a carbon fiber strut on the back that stores and returns energy, and a cuff that goes below the knee. It has a custom geometry and alignment that is specific to the individual.
DEVICEPhatBrace AFO
Although lighter and thinner than the Reaktiv it has a similar overall design. The posterior strut is typically longer and the footplate is thinner, more compliant and less customized. Further, the device is formed into a single piece.
Sponsors
Jason Wilken
Minneapolis Veterans Affairs Medical Center
Walter Reed National Military Medical Center
Henry M. Jackson Foundation for the Advancement of Military Medicine
Center for Veterans Research and Education
University of Delaware
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be cast, fit, and tested with each device in question (Reaktiv and PhatBrace AFO). Participants will be randomized to one of two arms (AB or BA) to maximize the likelihood of similarity between groups with respect to a range of anthropometric, demographic and injury related factors. We will use block randomization in groups of 4 to achieve equal randomization between groups over time.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Ages: 18-65 * Sustained a function limiting, below the knee, traumatic lower leg injury that occurred greater than two years ago * Weakness of ankle plantarflexors (\<4/5 on MMT), limited pain free ankle motion (DF\<10deg or PF\<20deg), mechanical pain with loading onto hindfoot/midfoot/forefoot (\>4/10 on verbal numeric pain rating scale), ankle or hindfoot fusion or candidate for ankle or hindfoot fusion, AND/OR a candidate for amputation secondary to ankle/foot impairment * Ability to walk 50 feet without using a cane or crutch * Ability to walk at a slow to moderate pace * Able to read and write in English and provide written informed consent
Exclusion criteria
* Pain \> 8/10 while walking * Ankle weakness as a result of spinal cord injury or central nervous system pathology * Require a knee stabilizing device (i.e. Knee-Ankle Foot Orthosis or Knee Orthosis) to perform daily activities * Surgery on study limb anticipated in the next 6 months * Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder, lung condition, stroke, vestibular disorder) * Nerve, muscle, bone, or other condition limiting function of the contralateral extremity * BMI greater than 45 * Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing * Pregnancy- Per participant self-report. Due the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Patient Reported Outcomes for Physical Function | 3 months | The Patient Reported Outcome Information System (PROMIS) physical function Computer Adaptive Test (CAT) is a computerized assessment measuring physical function. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average. |
| PROMIS Patient Reported Outcomes for Pain Interference | 3 months | The Patient Reported Outcome Information System (PROMIS) pain interference Computer Adaptive Test (CAT) is a computerized assessment measuring pain interference. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average. |
| Activities-Specific Balance Confidence (ABC) | 3 months | The Activities-Specific Balance Confidence (ABC) scale provides a standardized evaluation of balance confidence across a range of common daily tasks. Higher scores indicate more confidence, with 0 = no confidence and 100 = full confidence. |
| Satisfaction With Device (OPUS - CSD) | 3 months | Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score (11-55). Higher scores indicate a better outcome. |
| Modified Socket Comfort Score (Comfort) | 3 months | Comfort scores range from 0 = most uncomfortable to 10 = most comfortable. |
| Modified Socket Comfort Score (Comfort and Smoothness) | 3 months | Smoothness scores range from 0 = least smooth to 10 = most smooth. |
| Numerical Pain Rating Scale | 3 months | Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. |
| Participant Device Preference | After 3 months of accomodation with the final device (Crossover study) | The participant will rank order their preference for the Reaktiv and Phatbrace on a questionnaire. |
| Four-square Step Test (4SST- Timed) | 3 months | The 4SST is a standardized timed test of balance and agility. Measured in seconds with lower scores indicating better balance and agility. |
| Self-selected Walking Velocity (SSWV - Timed) | 3 months | SSWV will be assessed using the timed 10 meter walk test. Measured in seconds. |
| 10 Meter Shuttle Run (10M Shuttle - Timed) | 3 months | The 10 meter shuttle run is a well-established timed measure of speed. Measured in seconds. |
| Ankle Joint Power | 3 months | Peak ankle joint moment (W/kg) during gait. |
| Center of Pressure Velocity Timing | 3 months | Timing of peak center of pressure velocity (percent stance) during gait. |
| Center of Pressure Velocity Magnitude | 3 months | Magnitude of peak center of pressure velocity (m/s) during gait. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Patient Reported Outcomes for Satisfaction With Participation in Social Activities | 3 months | The Patient Reported Outcome Information System (PROMIS) satisfaction with participation in social activities Computer Adaptive Test (CAT) is a computerized assessment measuring satisfaction with participation in social activities. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average. |
| Paffenbarger Physical Activity Questionnaire | Baseline | Participants will report their physical activity using the Paffenbarger Physical Activity Questionnaire. Average hours of vigorous activity completed during the week and during the weekend will be recorded separately. Participants completed this questionnaire at the beginning of the study prior and reported baseline physical activity without wearing either CDO. |
| Ankle Joint Moment | 3 months | Peak ankle joint moment (Nm/kg) during gait. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJason M. Wilken, PT, PhD
University of Iowa
Participant flow
Pre-assignment details
Four (4) of the participants in this study failed the post-informed consent screening checklist, and were excluded form the study before being assigned to either group. The fifty (50) eligible participants were randomized to one of the two groups.
Participants by arm
| Arm | Count |
|---|---|
| Reaktiv, PhatBrace Participants in this arm will receive the Reaktiv AFO made by FabTech Systems LLC first, then the PhatBrace AFO by Bio-Mechanical Composites Inc. second.
Reaktiv AFO: This device is a carbon fiber ankle foot orthosis (brace) that contacts the foot and lower leg. It consists of a foot plate that is designed to protect the foot, a carbon fiber strut on the back that stores and returns energy, and a cuff that goes below the knee. It has a custom geometry and alignment that is specific to the individual.
PhatBrace AFO: Although lighter and thinner than the Reaktiv it has a similar overall design. The posterior strut is typically longer and the footplate is thinner, more compliant and less customized. Further, the device is formed into a single piece. | 12 |
| PhatBrace, Reaktiv Participants in this arm will receive the PhatBrace AFO by Bio-Mechanical Composites Inc. first, then the Reaktiv AFO made by FabTech Systems LLC second.
Reaktiv AFO: This device is a carbon fiber ankle foot orthosis (brace) that contacts the foot and lower leg. It consists of a foot plate that is designed to protect the foot, a carbon fiber strut on the back that stores and returns energy, and a cuff that goes below the knee. It has a custom geometry and alignment that is specific to the individual.
PhatBrace AFO: Although lighter and thinner than the Reaktiv it has a similar overall design. The posterior strut is typically longer and the footplate is thinner, more compliant and less customized. Further, the device is formed into a single piece. | 14 |
| Total | 26 |
Baseline characteristics
| Characteristic | Reaktiv, PhatBrace | PhatBrace, Reaktiv | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 13 Participants | 25 Participants |
| Age, Continuous | 38.3 years STANDARD_DEVIATION 10.4 | 44.5 years STANDARD_DEVIATION 10.8 | 41.7 years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 13 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 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 | 1 Participants | 1 Participants | 2 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 | 10 Participants | 13 Participants | 23 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 8 Participants | 10 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
10 Meter Shuttle Run (10M Shuttle - Timed)
The 10 meter shuttle run is a well-established timed measure of speed. Measured in seconds.
Time frame: 3 months
Population: One participant did not complete in-person physical performance measures in the PhatBrace condition, and their 10 meter shuttle run was unable to be collected as a result.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | 10 Meter Shuttle Run (10M Shuttle - Timed) | 19.05 Seconds | Standard Deviation 5.81 |
| PhatBrace | 10 Meter Shuttle Run (10M Shuttle - Timed) | 19.05 Seconds | Standard Deviation 6.41 |
Primary
Activities-Specific Balance Confidence (ABC)
The Activities-Specific Balance Confidence (ABC) scale provides a standardized evaluation of balance confidence across a range of common daily tasks. Higher scores indicate more confidence, with 0 = no confidence and 100 = full confidence.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | Activities-Specific Balance Confidence (ABC) | 76.37 units on a scale | Standard Deviation 19.66 |
| PhatBrace | Activities-Specific Balance Confidence (ABC) | 76.92 units on a scale | Standard Deviation 18.92 |
Primary
Ankle Joint Power
Peak ankle joint moment (W/kg) during gait.
Time frame: 3 months
Population: One participant did not complete the in-person biomechanics collection in the PhatBrace condition, and their ankle joint power was unable to be collected as a result.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | Ankle Joint Power | 1.43 W/kg | Standard Deviation 0.17 |
| PhatBrace | Ankle Joint Power | 1.29 W/kg | Standard Deviation 0.27 |
Primary
Center of Pressure Velocity Magnitude
Magnitude of peak center of pressure velocity (m/s) during gait.
Time frame: 3 months
Population: One participant did not complete the in-person biomechanics collection in the PhatBrace condition, and their center of pressure velocity was unable to be collected as a result.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | Center of Pressure Velocity Magnitude | 0.89 m/s | Standard Deviation 0.29 |
| PhatBrace | Center of Pressure Velocity Magnitude | 0.75 m/s | Standard Deviation 0.21 |
Primary
Center of Pressure Velocity Timing
Timing of peak center of pressure velocity (percent stance) during gait.
Time frame: 3 months
Population: One participant did not complete the in-person biomechanics collection in the PhatBrace condition, and their center of pressure velocity was unable to be collected as a result.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | Center of Pressure Velocity Timing | 25.81 percent of gait cycle | Standard Deviation 12.69 |
| PhatBrace | Center of Pressure Velocity Timing | 15.11 percent of gait cycle | Standard Deviation 8.83 |
Primary
Four-square Step Test (4SST- Timed)
The 4SST is a standardized timed test of balance and agility. Measured in seconds with lower scores indicating better balance and agility.
Time frame: 3 months
Population: One participant did not complete in-person physical performance measures in the PhatBrace condition, and their four-square step test time was unable to be collected as a result.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | Four-square Step Test (4SST- Timed) | 7.39 Seconds | Standard Deviation 1.72 |
| PhatBrace | Four-square Step Test (4SST- Timed) | 7.06 Seconds | Standard Deviation 1.78 |
Primary
Modified Socket Comfort Score (Comfort)
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | Modified Socket Comfort Score (Comfort) | 7.12 score on a scale | Standard Deviation 2.1 |
| PhatBrace | Modified Socket Comfort Score (Comfort) | 7.12 score on a scale | Standard Deviation 1.93 |
Primary
Modified Socket Comfort Score (Comfort and Smoothness)
Smoothness scores range from 0 = least smooth to 10 = most smooth.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | Modified Socket Comfort Score (Comfort and Smoothness) | 7.65 score on a scale | Standard Deviation 1.92 |
| PhatBrace | Modified Socket Comfort Score (Comfort and Smoothness) | 7.46 score on a scale | Standard Deviation 2.06 |
Primary
Numerical Pain Rating Scale
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
Time frame: 3 months
Population: One participant failed to complete in-person physical performance measures in the PhatBrace condition, and their reported numerical pain rating was unable to be collected as a result.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | Numerical Pain Rating Scale | 1.85 score on a scale | Standard Deviation 2.03 |
| PhatBrace | Numerical Pain Rating Scale | 1.68 score on a scale | Standard Deviation 1.75 |
Primary
Participant Device Preference
The participant will rank order their preference for the Reaktiv and Phatbrace on a questionnaire.
Time frame: After 3 months of accomodation with the final device (Crossover study)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reaktiv | Participant Device Preference | 10 Participants |
| PhatBrace | Participant Device Preference | 16 Participants |
Primary
PROMIS Patient Reported Outcomes for Pain Interference
The Patient Reported Outcome Information System (PROMIS) pain interference Computer Adaptive Test (CAT) is a computerized assessment measuring pain interference. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | PROMIS Patient Reported Outcomes for Pain Interference | 55.22 T-score | Standard Deviation 6.3 |
| PhatBrace | PROMIS Patient Reported Outcomes for Pain Interference | 53.49 T-score | Standard Deviation 6.52 |
Primary
PROMIS Patient Reported Outcomes for Physical Function
The Patient Reported Outcome Information System (PROMIS) physical function Computer Adaptive Test (CAT) is a computerized assessment measuring physical function. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | PROMIS Patient Reported Outcomes for Physical Function | 44.78 score on a scale | Standard Deviation 6.01 |
| PhatBrace | PROMIS Patient Reported Outcomes for Physical Function | 45.02 score on a scale | Standard Deviation 8.35 |
Primary
Satisfaction With Device (OPUS - CSD)
Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score (11-55). Higher scores indicate a better outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | Satisfaction With Device (OPUS - CSD) | 35.88 score on a scale | Standard Deviation 6.13 |
| PhatBrace | Satisfaction With Device (OPUS - CSD) | 36.04 score on a scale | Standard Deviation 8.06 |
Primary
Self-selected Walking Velocity (SSWV - Timed)
SSWV will be assessed using the timed 10 meter walk test. Measured in seconds.
Time frame: 3 months
Population: One participant did not complete in-person physical performance measures in the PhatBrace condition, and their self-selected walking velocity was unable to be collected as a result.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | Self-selected Walking Velocity (SSWV - Timed) | 4.46 Seconds | Standard Deviation 0.58 |
| PhatBrace | Self-selected Walking Velocity (SSWV - Timed) | 4.49 Seconds | Standard Deviation 0.6 |
Secondary
Ankle Joint Moment
Peak ankle joint moment (Nm/kg) during gait.
Time frame: 3 months
Population: One participant did not complete the in-person biomechanics collection in the PhatBrace condition, and their ankle joint moment was unable to be collected as a result.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | Ankle Joint Moment | 1.43 Nm/kg | Standard Deviation 0.17 |
| PhatBrace | Ankle Joint Moment | 1.29 Nm/kg | Standard Deviation 0.27 |
Secondary
Paffenbarger Physical Activity Questionnaire
Participants will report their physical activity using the Paffenbarger Physical Activity Questionnaire. Average hours of vigorous activity completed during the week and during the weekend will be recorded separately. Participants completed this questionnaire at the beginning of the study prior and reported baseline physical activity without wearing either CDO.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reaktiv | Paffenbarger Physical Activity Questionnaire | Average on weekday | 2.17 Hours | Standard Deviation 2.25 |
| Reaktiv | Paffenbarger Physical Activity Questionnaire | Average on weekend | 1.75 Hours | Standard Deviation 2.09 |
| PhatBrace | Paffenbarger Physical Activity Questionnaire | Average on weekday | 1.66 Hours | Standard Deviation 1.81 |
| PhatBrace | Paffenbarger Physical Activity Questionnaire | Average on weekend | 2.39 Hours | Standard Deviation 2.37 |
Secondary
PROMIS Patient Reported Outcomes for Satisfaction With Participation in Social Activities
The Patient Reported Outcome Information System (PROMIS) satisfaction with participation in social activities Computer Adaptive Test (CAT) is a computerized assessment measuring satisfaction with participation in social activities. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | PROMIS Patient Reported Outcomes for Satisfaction With Participation in Social Activities | 49.39 T-score | Standard Deviation 7.58 |
| PhatBrace | PROMIS Patient Reported Outcomes for Satisfaction With Participation in Social Activities | 48.42 T-score | Standard Deviation 7.22 |
Other Pre-specified
PROMIS Patient Reported Outcomes for Depression
The Patient Reported Outcome Information System (PROMIS) depression Computer Adaptive Test (CAT) is a computerized assessment measuring depression. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | PROMIS Patient Reported Outcomes for Depression | 48.24 T-score | Standard Deviation 9.72 |
| PhatBrace | PROMIS Patient Reported Outcomes for Depression | 48.35 T-score | Standard Deviation 8.86 |
Other Pre-specified
PROMIS Patient Reported Outcomes for Pain Behavior
The Patient Reported Outcome Information System (PROMIS) pain behavior Computer Adaptive Test (CAT) is a computerized assessment measuring pain behavior. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | PROMIS Patient Reported Outcomes for Pain Behavior | 55.22 T-score | Standard Deviation 5.6 |
| PhatBrace | PROMIS Patient Reported Outcomes for Pain Behavior | 54.45 T-score | Standard Deviation 7.79 |
Other Pre-specified
PROMIS Patient Reported Outcomes for Satisfaction With Participation in Social Roles
The Patient Reported Outcome Information System (PROMIS) satisfaction with participation in social roles Computer Adaptive Test (CAT) is a computerized assessment measuring satisfaction with participation in social roles. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | PROMIS Patient Reported Outcomes for Satisfaction With Participation in Social Roles | 49.37 T-score | Standard Deviation 8.56 |
| PhatBrace | PROMIS Patient Reported Outcomes for Satisfaction With Participation in Social Roles | 48.70 T-score | Standard Deviation 7.48 |
Other Pre-specified
Satisfaction With Services (OPUS - CSS)
Satisfaction with services will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Services Score (10-50). Higher scores indicate a better outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | Satisfaction With Services (OPUS - CSS) | 40.04 score on a scale | Standard Deviation 8.47 |
| PhatBrace | Satisfaction With Services (OPUS - CSS) | 38.65 score on a scale | Standard Deviation 8.75 |
Other Pre-specified
Sit to Stand 5 Times (STS5 - Timed)
STS5 is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to stand up and sit down 5 times as fast as possible.
Time frame: 3 months
Population: One participant did not complete in-person physical performance measures in the PhatBrace condition, and their sit-to-stand time was unable to be collected as a result.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | Sit to Stand 5 Times (STS5 - Timed) | 8.94 Seconds | Standard Deviation 2.2 |
| PhatBrace | Sit to Stand 5 Times (STS5 - Timed) | 8.82 Seconds | Standard Deviation 2.55 |
Other Pre-specified
Timed Stair Ascent (TSA - Timed)
The timed stair ascent test is a measure of mobility, agility, and lower limb muscle strength. Participants are instructed to ascend a flight of 12 steps as quickly and safely as possible while contacting every step.
Time frame: 3 months
Population: One participant did not complete in-person physical performance measures in the PhatBrace condition, and timed stair ascent was unable to be collected as a result.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reaktiv | Timed Stair Ascent (TSA - Timed) | 5.82 Seconds | Standard Deviation 2.97 |
| PhatBrace | Timed Stair Ascent (TSA - Timed) | 5.43 Seconds | Standard Deviation 2.6 |