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Custom ankle braces could help stroke patients walk better

NCT ID NCT06304519

Knowledge-focused Sponsor: University of Delaware Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested different levels of stiffness in custom ankle braces for 40 people who had a stroke. The goal was to find the best brace for each person and create simple guidelines that doctors and therapists can use to prescribe the right brace. Participants walked with five different brace settings, and researchers measured walking function, clinical tests, and patient feedback.

What this could mean

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

Active substance
customized carbon fiber ankle-foot orthosis (brace)
What this could lead to
If successful, this could lead to simple guidelines that help clinicians pick the right ankle brace for each stroke survivor, improving walking ability.
What could go wrong
This is a small, early-stage study with only 40 participants. The guidelines may not work for everyone and need more testing before they can be widely used.

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

40 people

The number who actually took part.

Started

Mar 2023

Finished

Mar 2026

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

21 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: * chronic stroke (\> 6 months post-stroke) * been prescribed an AFO by a clinician * have plantar flexor strength deficits (unable to complete at least 25 standing heel-raises * have at least 5 degrees of passive dorsiflexion range of motion (as measured during the clinical evaluation in Visit 1). Exclusion Criteria: * Those that will not be included in this study are individuals with 1) Evidence of cerebellar stroke on clinical MRI, 2) Other neurologic conditions in addition to stroke, 3) Sensorimotor neglect, 4) Inability to walk outside the home prior to the stroke, 5) Total joint replacement or orthopedic problems in the lower limbs or spine that limit walking, 6) Coronary artery bypass graft or myocardial infarction within past 3 months, 7) Unexplained dizziness in last 6 months, 8) Inability to communicate with investigators, 9) Lack of decisional capacity.

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Conditions

The condition(s) this trial relates to.

stroke disorder

As listed by the trial registrant

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

Stroke

Contacts and locations

Locations

  • University of Delaware STAR Campus

    Newark, Delaware, 19713, United States

More trials for these conditions

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