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New foot rehab aims to stop ankle sprains from coming back

NCT ID NCT04493645

Disease control Sponsor: Matthew Hoch Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares a standard rehab program to a foot-intensive rehab (FIRE) program in 150 adults aged 18-44 with chronic ankle instability. Participants do 2 supervised and 3 home sessions per week for 6 weeks. The goal is to see if FIRE reduces re-injury rates, improves stability, and lessens symptoms better than standard care.

What this could mean

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

Active substance
foot-intensive rehabilitation (FIRE) program
What this could lead to
If successful, this could provide a more effective rehab approach to reduce ankle sprains and improve stability in people with chronic ankle instability.
What could go wrong
This is a mid-sized trial comparing two rehab programs, so results may not apply to everyone. The intervention requires significant commitment (2 supervised and 3 home sessions per week for 6 weeks).

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 150 people

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

Started

Oct 2021

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 44 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. Aged 18-44. 2. Previous history of at least 1 ankle sprain and at least 2 episodes of "giving way" in the past 3 months. 3. Participants must answer "yes" to at least 5 questions on the Ankle Instability Instrument. 4. Score of 11 or higher on the Identification of Functional Ankle Instability (IdFAI). 5. Confirmed clinical presentation of CAI by a PT, AT, or MD. Exclusion Criteria: 1. Sustained an ankle sprain in the previous four weeks or lower extremity neuromusculoskeletal injury other than to the ankle in the last 12 months. 2. History of surgery to the lower extremity. 3. Sustained a lower extremity fracture. 4. History of neurological disease, vestibular or visual disturbance or any other pathology that would impair their sensorimotor performance. 5. Current participation in a formal ankle joint rehabilitation program. 6. Sustained a concussion in the last 12 months. 7. Exhibit clinical examination characteristics of foot and ankle function which are consistent with conditions other than CAI (i.e. fracture, deformity).

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Conditions

The condition(s) this trial relates to.

ankle injury injury

As listed by the trial registrant

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

Ankle injuries Ankle sprains

Contacts and locations

Locations

  • University of Kentucky

    Lexington, Kentucky, 40536-0200, United States

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