Foot Injuries and DisordersAFOCENCT03901053
Ankle Foot Orthosis Comparative Effect
A study testing Reaktiv AFO and PhatBrace AFO in people with Foot Injuries and Disorders, run by Jason Wilken at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Foot Injuries and Disorders
- What is being tested?
- Reaktiv AFO and PhatBrace AFO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Feb 2020to 18 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
University of Iowa
Iowa City, Iowa, 52242
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417
About this study
Official title: Comparative Effect of Commercially Available Custom Dynamic Orthoses (CDOs)
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.
Read the 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.
- Conditions
- Foot Injuries and Disorders
- Being tested
- Reaktiv AFO, PhatBrace AFO
- Keywords
- Ankle Foot Orthoses, Carbon Fiber, Gait, Adult, Biomechanics, Materials Testing, Physical Performance
- Medical subject headings
- Foot Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reaktiv AFODevice
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 AFODevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Reaktiv AFO; Device: PhatBrace AFO |
| 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. Receives: Device: Reaktiv AFO; Device: PhatBrace AFO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Modified Socket Comfort Score (Comfort)
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.
Measured: 3 months
Modified Socket Comfort Score (Comfort and Smoothness)
Smoothness scores range from 0 = least smooth to 10 = most smooth.
Measured: 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.
Measured: 3 months
Participant Device Preference
The participant will rank order their preference for the Reaktiv and Phatbrace on a questionnaire.
Measured: 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.
Measured: 3 months
Self-selected Walking Velocity (SSWV - Timed)
SSWV will be assessed using the timed 10 meter walk test. Measured in seconds.
Measured: 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.
Measured: 3 months
Ankle Joint Power
Peak ankle joint moment (W/kg) during gait.
Measured: 3 months
Center of Pressure Velocity Timing
Timing of peak center of pressure velocity (percent stance) during gait.
Measured: 3 months
Center of Pressure Velocity Magnitude
Magnitude of peak center of pressure velocity (m/s) during gait.
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: Baseline
Ankle Joint Moment
Peak ankle joint moment (Nm/kg) during gait.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start27 Feb 2020
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Foot Injuries and DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jason Wilken
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor-investigator, Jason Wilken, University of Iowa
- Investigators
- Jason M. Wilken, PT, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901053
- Sponsor's protocol ID
- 201901829
- Other IDs
- CDMRP-OP170060
- Acronym
- AFOCE
- Status last verified
- Oct 2025
- First submitted
- 25 Mar 2019
- Last updated
- 29 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Commercially Available Custom Dynamic Orthoses (CDOs)
- ClinicalTrials.gov ID
- NCT03901053
- Acronym / sponsor ID
- AFOCE / 201901829
- Conditions
- Foot Injuries and Disorders
- Keywords
- Ankle Foot Orthoses, Carbon Fiber, Gait, Adult, Biomechanics, Materials Testing, Physical Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Jason WilkenUniversity, hospital or other
- Collaborators
- 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 start
- 27 Feb 2020 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Posted 31 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| AB | Experimental | Device: Reaktiv AFO, Device: PhatBrace AFOParticipants 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 | Device: Reaktiv AFO, Device: PhatBrace AFOParticipants in this arm will receive the PhatBrace AFO by Bio-Mechanical Composites Inc. first, then the Reaktiv AFO made by FabTech Systems LLC second. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reaktiv AFOThis 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. | Device | AB, BA |
| PhatBrace AFOAlthough 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. | Device | AB, BA |
Primary outcome
PROMIS Patient Reported Outcomes for Physical Function
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 3 months
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.
Modified Socket Comfort Score (Comfort and Smoothness)
Time frame: 3 months
Smoothness scores range from 0 = least smooth to 10 = most smooth.
Numerical Pain Rating Scale
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 3 months
SSWV will be assessed using the timed 10 meter walk test. Measured in seconds.
10 Meter Shuttle Run (10M Shuttle - Timed)
Time frame: 3 months
The 10 meter shuttle run is a well-established timed measure of speed. Measured in seconds.
Ankle Joint Power
Time frame: 3 months
Peak ankle joint moment (W/kg) during gait.
Center of Pressure Velocity Timing
Time frame: 3 months
Timing of peak center of pressure velocity (percent stance) during gait.
Center of Pressure Velocity Magnitude
Time frame: 3 months
Magnitude of peak center of pressure velocity (m/s) during gait.
3 secondary outcomes
PROMIS Patient Reported Outcomes for Satisfaction With Participation in Social Activities
Time frame: 3 months
Paffenbarger Physical Activity Questionnaire
Time frame: Baseline
Ankle Joint Moment
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason M. Wilken, PT, PhD principal investigator
University of Iowa
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reaktiv AFO and PhatBrace AFO in people with Foot Injuries and Disorders, run by Jason Wilken at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Patient Reported Outcomes for Physical Function (time frame: 3 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.