Trial Outcomes & Findings for Ankle Foot Orthosis Comparative Effect (NCT NCT03901053)

NCT ID: NCT03901053

Last Updated: 2026-01-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 54 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2026-01-29

Participant Flow

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.

Participant milestones

Measure	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.	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.
Overall Study STARTED	25	25
Overall Study COMPLETED	12	14
Overall Study NOT COMPLETED	13	11

Reasons for withdrawal

Measure	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.	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.
Overall Study Lost to Follow-up	6	2
Overall Study Withdrawal by Subject	4	3
Overall Study Unsatisfactory Device	1	2
Overall Study No longer meets study criteria	1	3
Overall Study Subject's Medical Status	0	1
Overall Study Screening Failure	1	0

Baseline Characteristics

Ankle Foot Orthosis Comparative Effect

Baseline characteristics by cohort

Measure	Reaktiv, PhatBrace n=12 Participants 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.	PhatBrace, Reaktiv n=14 Participants 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.	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=35 Participants	13 Participants n=4328 Participants	25 Participants n=8687 Participants
Age, Categorical >=65 years	0 Participants n=35 Participants	1 Participants n=4328 Participants	1 Participants n=8687 Participants
Age, Continuous	38.3 years STANDARD_DEVIATION 10.4 • n=35 Participants	44.5 years STANDARD_DEVIATION 10.8 • n=4328 Participants	41.7 years STANDARD_DEVIATION 10.9 • n=8687 Participants
Sex: Female, Male Female	4 Participants n=35 Participants	4 Participants n=4328 Participants	8 Participants n=8687 Participants
Sex: Female, Male Male	8 Participants n=35 Participants	10 Participants n=4328 Participants	18 Participants n=8687 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=35 Participants	1 Participants n=4328 Participants	3 Participants n=8687 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=35 Participants	13 Participants n=4328 Participants	23 Participants n=8687 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=35 Participants	0 Participants n=4328 Participants	1 Participants n=8687 Participants
Race (NIH/OMB) Asian	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Black or African American	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) White	10 Participants n=35 Participants	13 Participants n=4328 Participants	23 Participants n=8687 Participants
Race (NIH/OMB) More than one race	1 Participants n=35 Participants	1 Participants n=4328 Participants	2 Participants n=8687 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=26 Participants 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.
PROMIS Patient Reported Outcomes for Physical Function	44.78 score on a scale Standard Deviation 6.01	45.02 score on a scale Standard Deviation 8.35

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=26 Participants 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.
PROMIS Patient Reported Outcomes for Pain Interference	55.22 T-score Standard Deviation 6.30	53.49 T-score Standard Deviation 6.52

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=26 Participants 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.
Activities-Specific Balance Confidence (ABC)	76.37 units on a scale Standard Deviation 19.66	76.92 units on a scale Standard Deviation 18.92

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=26 Participants 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.
Satisfaction With Device (OPUS - CSD)	35.88 score on a scale Standard Deviation 6.13	36.04 score on a scale Standard Deviation 8.06

PRIMARY outcome

Timeframe: 3 months

Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=26 Participants 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.
Modified Socket Comfort Score (Comfort)	7.12 score on a scale Standard Deviation 2.10	7.12 score on a scale Standard Deviation 1.93

PRIMARY outcome

Timeframe: 3 months

Smoothness scores range from 0 = least smooth to 10 = most smooth.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=26 Participants 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.
Modified Socket Comfort Score (Comfort and Smoothness)	7.65 score on a scale Standard Deviation 1.92	7.46 score on a scale Standard Deviation 2.06

PRIMARY outcome

Timeframe: 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.

Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=25 Participants 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.
Numerical Pain Rating Scale	1.85 score on a scale Standard Deviation 2.03	1.68 score on a scale Standard Deviation 1.75

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=26 Participants 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.
Participant Device Preference	10 Participants	16 Participants

PRIMARY outcome

Timeframe: 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.

The 4SST is a standardized timed test of balance and agility. Measured in seconds with lower scores indicating better balance and agility.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=25 Participants 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.
Four-square Step Test (4SST- Timed)	7.39 Seconds Standard Deviation 1.72	7.06 Seconds Standard Deviation 1.78

PRIMARY outcome

Timeframe: 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.

SSWV will be assessed using the timed 10 meter walk test. Measured in seconds.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=25 Participants 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.
Self-selected Walking Velocity (SSWV - Timed)	4.46 Seconds Standard Deviation 0.58	4.49 Seconds Standard Deviation 0.60

PRIMARY outcome

Timeframe: 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.

The 10 meter shuttle run is a well-established timed measure of speed. Measured in seconds.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=25 Participants 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.
10 Meter Shuttle Run (10M Shuttle - Timed)	19.05 Seconds Standard Deviation 5.81	19.05 Seconds Standard Deviation 6.41

PRIMARY outcome

Timeframe: 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.

Peak ankle joint moment (W/kg) during gait.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=25 Participants 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.
Ankle Joint Power	1.43 W/kg Standard Deviation 0.17	1.29 W/kg Standard Deviation 0.27

PRIMARY outcome

Timeframe: 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.

Timing of peak center of pressure velocity (percent stance) during gait.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=25 Participants 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.
Center of Pressure Velocity Timing	25.81 percent of gait cycle Standard Deviation 12.69	15.11 percent of gait cycle Standard Deviation 8.83

PRIMARY outcome

Timeframe: 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.

Magnitude of peak center of pressure velocity (m/s) during gait.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=25 Participants 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.
Center of Pressure Velocity Magnitude	0.89 m/s Standard Deviation 0.29	0.75 m/s Standard Deviation 0.21

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=26 Participants 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.
PROMIS Patient Reported Outcomes for Satisfaction With Participation in Social Activities	49.39 T-score Standard Deviation 7.58	48.42 T-score Standard Deviation 7.22

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Reaktiv n=12 Participants 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 n=14 Participants 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.
Paffenbarger Physical Activity Questionnaire Average on weekday	2.17 Hours Standard Deviation 2.25	1.66 Hours Standard Deviation 1.81
Paffenbarger Physical Activity Questionnaire Average on weekend	1.75 Hours Standard Deviation 2.09	2.39 Hours Standard Deviation 2.37

SECONDARY outcome

Timeframe: 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.

Peak ankle joint moment (Nm/kg) during gait.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=25 Participants 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.
Ankle Joint Moment	1.43 Nm/kg Standard Deviation 0.17	1.29 Nm/kg Standard Deviation 0.27

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

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.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=26 Participants 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.
PROMIS Patient Reported Outcomes for Pain Behavior	55.22 T-score Standard Deviation 5.60	54.45 T-score Standard Deviation 7.79

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

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.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=26 Participants 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.
PROMIS Patient Reported Outcomes for Depression	48.24 T-score Standard Deviation 9.72	48.35 T-score Standard Deviation 8.86

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

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.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=26 Participants 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.
PROMIS Patient Reported Outcomes for Satisfaction With Participation in Social Roles	49.37 T-score Standard Deviation 8.56	48.70 T-score Standard Deviation 7.48

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Satisfaction with services will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Services Score (10-50). Higher scores indicate a better outcome.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=26 Participants 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.
Satisfaction With Services (OPUS - CSS)	40.04 score on a scale Standard Deviation 8.47	38.65 score on a scale Standard Deviation 8.75

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=25 Participants 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.
Sit to Stand 5 Times (STS5 - Timed)	8.94 Seconds Standard Deviation 2.20	8.82 Seconds Standard Deviation 2.55

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Reaktiv n=26 Participants 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 n=25 Participants 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.
Timed Stair Ascent (TSA - Timed)	5.82 Seconds Standard Deviation 2.97	5.43 Seconds Standard Deviation 2.60

Adverse Events

Reaktiv

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PhatBrace

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jason M. Wilken, PT, PhD

The University of Iowa

Phone: 319-335-6857

Email: jason-wilken@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place