Can sensors make braces better? new study aims to find out
NCT ID NCT06127264
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
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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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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- 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 90 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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.
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.
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The places running it
1 site. The list below names each one and where it is.
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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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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
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University of Iowa
RECRUITINGIowa City, Iowa, 52241, United States
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