Could a carbon fiber ankle brace help people with Parkinson's walk better?

NCT ID NCT03192046

Completed Symptom relief Sponsor: University of Texas Southwestern Medical Center Source: ClinicalTrials.gov ↗

The trial has finished. Results may not be published yet.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial tests whether wearing a custom carbon fiber ankle-foot orthosis (AFO) during a walking program can improve gait and quality of life in people with Parkinson's disease. Participants will be randomly assigned to either use the brace while walking or follow a standard walking program without a brace. The study measures changes in walking endurance, step length, and other gait parameters over six months.

What this could mean

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

Active substance: Carbon fiber ankle-foot orthosis (AFO) brace used during a walking program
What this could lead to: If effective, carbon fiber AFOs could offer a new way to improve walking speed, step length, and daily quality of life for people with Parkinson's disease.
What could go wrong: This is a very small early trial (10 people), so results may not apply broadly. The brace may not improve gait for everyone, and some may find it uncomfortable or impractical.

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

10 people

The number who actually took part.

Started

Sep 2016

Finished

Dec 2020

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

30 to 85 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.

Inclusion Criteria: 1. Confirmed diagnosis of Parkinson's Disease according to the UK brain bank criteria.5 2. Age between 30 and 85. 3. Measurable decrement in gait velocity (between 35 and 15 percent below age-predicted norms for self-selected walking velocity) as measured by the 6 MWT 4. Hoehn and Yahr stage 2-3. 5. Less than 10 full heel raises in single limb stance bilaterally. Exclusion Criteria: 1. Body mass index greater than 40. 2. Passive dorsiflexion range of motion less than approximately neutral (90 degrees) 3. Any other uncontrolled health condition for which gait training is contraindicated 4. Self-report of \> 1 fall/month 5. A score of 11 or less on the Short Orientation-Memory-Concentration Test of Cognitive Impairment

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for GAIT DISORDERS, NEUROLOGIC are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Gait Disorders, Neurologic Parkinson disease

As listed by the trial registrant

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

GAIT DISORDERS, NEUROLOGIC PARKINSON DISEASE

Contacts and locations

Locations

UT Southwestern

Dallas, Texas, 75235, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.