Can sensors make braces better? new study aims to find out

NCT ID NCT06127264

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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 Results may not be published yet.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
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Status unknown
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First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study checks if special sensors can reliably measure forces inside carbon fiber ankle-foot braces (orthoses). Researchers will test healthy volunteers and people with or without neuropathy who already use such braces. Participants will walk, sit, and stand while sensors record forces in the brace cuff and footplate.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could improve how orthoses are fitted and adjusted for people who need them.
What could go wrong
This is a small, early-stage reliability study, not testing a treatment. Results may not change clinical practice directly.

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

Mar 2024

Expected to finish

Dec 2026

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 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Group 1 - Able Bodied Participants Inclusion Criteria * Between the ages of 18 and 65 * Healthy without current complaint of lower extremity pain, spine pain, open wounds or active infections, or medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months * Able to hop without pain * Able to perform a full squat without pain * Ability to read and write in English and provide written informed consent * Ability to fit in a generic sized CDO Exclusion Criteria * Diagnosed with a moderate or severe brain injury * Lower extremity injury resulting in surgery or limiting function for greater than 6 weeks * Injuries that would limit performance in this study * Diagnosed with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition) * Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing * Require use of an assistive device * Unhealed wounds (cuts/abrasions) that would prevent AFO use * BMI \> 40 * Pregnancy Group 2 - AFO Users without Peripheral Neuropathy Inclusion Criteria: * Between the ages of 18 and 90 * Use an AFO(s) for daily activities * The AFO(s) proximal cuff is compatible with loadpad sensors * Have used their AFO(s) for a minimum of 2 weeks * Ability to walk 50 feet without use of an assistive device (e.g. cane, crutch, etc.) * Ability to read and write in English and provide written informed consent Exclusion Criteria * Diagnosis or indication of peripheral neuropathy determined using Semmes Weinstein Filaments * Medical or psychological condition that would preclude functional testing (ex. Moderate or severe brain injury, stroke, heart disease) * Requirement of a knee stabilizing device (e.g. KAFO, KO) to preform daily activities * Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing * BMI \> 40 * Pregnancy Group 3 - AFO Users with Peripheral Neuropathy Inclusion Criteria: * Between the ages of 18 and 90 * Use an AFO(s) for daily activities * The AFO(s) proximal cuff is compatible with loadpad sensors * Have used their AFO(s) for a minimum of 2 weeks * Ability to walk 50 feet without use of an assistive device (e.g. cane, crutch, etc.) * Diagnosis or indication of peripheral neuropathy determined using Semmes Weinstein Filaments * Ability to read and write in English and provide written informed consent Exclusion Criteria * Medical or psychological condition that would preclude functional testing (ex. Moderate or severe brain injury, stroke, heart disease) * Requirement of a knee stabilizing device (e.g. KAFO, KO) to preform daily activities * Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing * BMI \> 40 * Pregnancy

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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.

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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52241, United States

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