Clinical trial Recruiting at 1 site Interventional Ages 18 to 45

Auditory biofeedback gait training for chronic ankle instability

Official title: Optimizing Retention on Duty in Patients With Chronic Ankle Instability Using Auditory Biofeedback Gait Training: A Multisite Randomized Controlled Trial

Run by University of Kentucky · NCT06868316 · Data updated 2026-11-12

This test will try using sound feedback during walking, rucking, and running to improve gait mechanics and reduce giving-way episodes in physically active adults with chronic ankle instability.

Quick facts

Study typeInterventional
Ages18 Years to 45 Years
SexAll
Enrollment100 (estimated)
SponsorUniversity of Kentucky
Academic / other
Locations2 sites (Lexington, Kentucky and 1 other locations)
StatusRecruiting
StartedMay 27, 2025
Main results expectedJune 2028
Study endsSeptember 2028
Registry record updatedJuly 21, 2026
Trial IDNCT06868316 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Physically active adults who can run at least 20 consecutive minutes, have a history of ankle sprain, at least two giving-way episodes in the past six months, and meet AII and IdFAI thresholds are ideal candidates.

Probably not a fit

People with an ankle sprain within the past four weeks, recent lower-extremity injury other than the ankle, prior lower-extremity surgery or recent serious fracture, neurological/vestibular/visual disorders, or current formal ankle rehabilitation are unlikely to be eligible or benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial will assign physically active adults with chronic ankle instability to a six-week gait training program using auditory biofeedback or to a control condition. Participants will complete 12 supervised sessions over six weeks involving walking, ruck marching, and running, with biomechanical and clinical testing before and after the intervention. Primary outcomes include lower-extremity biomechanics, talar cartilage deformation, frequency of giving-way episodes, and patient-reported symptom severity. The protocol is designed to detect short- and longer-term changes in movement patterns and ankle joint health.

Why it matters

Potential benefit: If successful, the program could improve gait mechanics, reduce giving-way episodes and symptom severity, and potentially protect talar cartilage to lower future ankle degeneration risk.

How similar studies have gone: Gait biofeedback has produced biomechanical improvements in other lower-extremity conditions, but auditory biofeedback specifically applied to chronic ankle instability is relatively novel and not yet well-established.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Physically active adults (defined as participants reporting a score of =4 on the National Aeronautics and Space Administration (NASA) Activity Instrument and indicating they can run for at least 20 consecutive minutes)
* History of ankle sprain
* 2 episodes of "giving way" in the past 6-months
* must answer "yes" to =5 questions on the Ankle Instability Instrument (AII) and =11 on the Identification of Functional Ankle Instability (IdFAI)

Exclusion Criteria:

* an ankle sprain in the previous four weeks or lower extremity neuromusculoskeletal injury other than to the ankle in the last 12 months
* history of surgery in the lower extremity
* fracture to the lower extremity in the past 12 months or a fracture that required open-reduction internal fixation
* history of neurological disease, vestibular or visual disturbance or any other pathology that would impair sensorimotor performance or gait
* current participation in a formal ankle joint rehabilitation program
* a concussion in the last 12 months
* report a cardiovascular, metabolic, or renal disease, or signs and symptoms that suggest such condition or have been told by a medical provider not to engage in vigorous physical activity (such as running).

Where it's running

  • University of Kentucky
    Lexington, Kentucky, United States
    Recruiting
  • University of North Carolina at Charlotte
    Charlotte, North Carolina, United States
    Not yet recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.