NCT06868316 Auditory Biofeedback Gait Training Individuals With Chronic Ankle Instability
| NCT ID | NCT06868316 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Danielle Torp |
| Condition | Ankle Sprains |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-05-27 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-05-27 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this randomized clinical controlled trial is examine the effects of gait training with auditory biofeedback (AudFB) on gait biomechanics, clinical measures of ankle joint health, and patient-centered outcomes. The following specific aims will achieve this objective: * Specific Aim 1: Determine if a 6-week gait training with AudFB intervention improves lower extremity biomechanics compared to a Control condition in participants with CAI. * Specific Aim 2: Determine if a 6-week gait training with AudFB reduces talar cartilage deformation compared to a Control condition in participants with CAI. * Specific Aim 3: Determine if a 6-week gait training with AudFB reduces episodes of ankle giving-way and reduces self-perceived severity of symptoms relative to a Control condition in participants with CAI. Participants will: * Complete 12 intervention sessions over a 6-week period of walking, ruck marching, and runninig. * Complete testing sessions before and after the intervention, then after 6 and 12-months following the intervention.
Eligibility 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06868316 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Ankle Sprains. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06868316 currently recruiting?
Yes, NCT06868316 is actively recruiting participants. Contact the research team at danielle.torp@uky.edu for enrollment information.
Where is the NCT06868316 trial being conducted?
This trial is being conducted at Lexington, United States, Charlotte, United States.
Who is sponsoring the NCT06868316 clinical trial?
NCT06868316 is sponsored by Danielle Torp. The trial plans to enroll 100 participants.