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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-OP170060 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| Minneapolis Veterans Affairs Medical Center | FED |
| Walter Reed National Military Medical Center | FED |
| Henry M. Jackson Foundation for the Advancement of Military Medicine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AB | Experimental | 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. |
|
| BA | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reaktiv AFO | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| 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. | 3 months |
| 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. | 3 months |
| 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. | 3 months |
| Modified Socket Comfort Score (Comfort) | Comfort scores range from 0 = most uncomfortable to 10 = most comfortable. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason M. Wilken, PT, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States | ||
| Walter Reed National Military Medical Center |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants completed study activities in each of the experimental conditions in a randomized order (Reaktiv, PhatBrace; PhatBrace Reaktiv)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
Study participants were asked to indicate any adverse events throughout the duration of each study visit. After completion of the study participants were also asked to call or email the research team if any adverse events related to the study occurred after the study visit (up to ~12 months after the visit).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reaktiv | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason M. Wilken, PT, PhD | The University of Iowa | 319-335-6857 | jason-wilken@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2024 | Jan 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018409 | Foot Injuries |
| D004194 | Disease |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Center for Veterans Research and Education |
| OTHER |
| University of Delaware | OTHER |
| Johns Hopkins Bloomberg School of Public Health | OTHER |
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.
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|
| PhatBrace AFO | Device | 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. |
|
| Modified Socket Comfort Score (Comfort and Smoothness) |
Smoothness scores range from 0 = least smooth to 10 = most smooth. |
| 3 months |
| 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. | 3 months |
| Participant Device Preference | The participant will rank order their preference for the Reaktiv and Phatbrace on a questionnaire. | After 3 months of accomodation with the final device (Crossover study) |
| 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. | 3 months |
| Self-selected Walking Velocity (SSWV - Timed) | SSWV will be assessed using the timed 10 meter walk test. Measured in seconds. | 3 months |
| 10 Meter Shuttle Run (10M Shuttle - Timed) | The 10 meter shuttle run is a well-established timed measure of speed. Measured in seconds. | 3 months |
| Ankle Joint Power | Peak ankle joint moment (W/kg) during gait. | 3 months |
| Center of Pressure Velocity Timing | Timing of peak center of pressure velocity (percent stance) during gait. | 3 months |
| Center of Pressure Velocity Magnitude | Magnitude of peak center of pressure velocity (m/s) during gait. | 3 months |
| 3 months |
| 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. | Baseline |
| Ankle Joint Moment | Peak ankle joint moment (Nm/kg) during gait. | 3 months |
| 3 months |
| 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. | 3 months |
| 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. | 3 months |
| 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. | 3 months |
| 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. | 3 months |
| 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. | 3 months |
| Bethesda |
| Maryland |
| 20889 |
| United States |
| Minneapolis VA Health Care System | Minneapolis | Minnesota | 55417 | United States |
| Unsatisfactory Device |
|
| No longer meets study criteria |
|
| Subject's Medical Status |
|
| Screening Failure |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | PhatBrace | 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | T-score | 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Primary | Modified Socket Comfort Score (Comfort) | Comfort scores range from 0 = most uncomfortable to 10 = most comfortable. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Primary | Modified Socket Comfort Score (Comfort and Smoothness) | Smoothness scores range from 0 = least smooth to 10 = most smooth. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Primary | Participant Device Preference | The participant will rank order their preference for the Reaktiv and Phatbrace on a questionnaire. | Posted | Count of Participants | Participants | After 3 months of accomodation with the final device (Crossover study) |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Seconds | 3 months |
|
|
|
| Primary | Self-selected Walking Velocity (SSWV - Timed) | SSWV will be assessed using the timed 10 meter walk test. Measured in seconds. | 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. | Posted | Mean | Standard Deviation | Seconds | 3 months |
|
|
|
| Primary | 10 Meter Shuttle Run (10M Shuttle - Timed) | The 10 meter shuttle run is a well-established timed measure of speed. Measured in seconds. | 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. | Posted | Mean | Standard Deviation | Seconds | 3 months |
|
|
|
| Primary | Ankle Joint Power | Peak ankle joint moment (W/kg) during gait. | 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. | Posted | Mean | Standard Deviation | W/kg | 3 months |
|
|
|
| Primary | Center of Pressure Velocity Timing | Timing of peak center of pressure velocity (percent stance) during gait. | 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. | Posted | Mean | Standard Deviation | percent of gait cycle | 3 months |
|
|
|
| Primary | Center of Pressure Velocity Magnitude | Magnitude of peak center of pressure velocity (m/s) during gait. | 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. | Posted | Mean | Standard Deviation | m/s | 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | T-score | 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Hours | Baseline |
|
|
|
| Secondary | Ankle Joint Moment | Peak ankle joint moment (Nm/kg) during gait. | 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. | Posted | Mean | Standard Deviation | Nm/kg | 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | T-score | 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | T-score | 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | T-score | 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Seconds | 3 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Seconds | 3 months |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | PhatBrace | 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. | 0 | 50 | 0 | 50 | 0 | 50 |
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