Which brace helps leg injury patients walk better? study compares two custom designs.
NCT ID NCT03901053
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested two custom carbon fiber braces (Reaktiv and PhatBrace) in 54 adults who had a serious lower leg injury at least two years earlier. Participants tried both braces and reported on pain, balance, walking speed, and comfort. The goal was to see which brace works better for daily function and to help doctors make informed choices.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Custom carbon fiber ankle-foot orthosis (brace)
- What this could lead to
- If one brace proves better, it could help doctors choose the best option to improve walking and reduce pain after serious leg injuries.
- What could go wrong
- This is a small, completed study comparing two specific braces. Results may not apply to all injuries or other brace types. Individual fit and comfort vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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54 people
The number who actually took part.
- Started
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Feb 2020
- Finished
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Dec 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417, United States
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University of Iowa
Iowa City, Iowa, 52242, United States
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Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
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