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New carbon fiber braces aim to ease foot pain and improve walking

NCT ID NCT06710119

Symptom relief Sponsor: University of Iowa Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests custom carbon fiber foot braces (orthoses) in 60 adults with lower leg injuries. Researchers measure how the braces reduce pressure on the forefoot during walking, and whether adding visual feedback or home use helps further. The goal is to improve comfort and recovery.

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

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Patient Inclusion criteria * Ages: 18-65 * Sustained a function limiting injury below the knee, requiring a carbon fiber custom dynamic orthosis * Shoe size between women's 8 and 13.5 or men's 6.5 and 13 * Any of the following: 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, candidate for ankle or hindfoot fusion, candidate for amputation secondary to ankle/foot impairment * Ability to walk 25 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 Patient Exclusion criteria * Pain \> 9/10 while walking * Ankle weakness as a result of spinal cord injury or central nervous system pathology * AFO or CDO prescription that includes a knee brace or goes up to thigh * 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 40 * Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing * Pregnancy

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lower extremity injuries

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cornerstone Prosthetics and Orthotics

    RECRUITING

    Everett, Washington, 98225, United States

  • University of Iowa

    ACTIVE_NOT_RECRUITING

    Iowa City, Iowa, 52241, United States

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