Auditory Biofeedback Gait Training in Individuals With Chronic Ankle Instability: Protocol for a Randomized...

Chronic ankle instability (CAI) develops in a large majority of patients with lateral ankle sprain (LAS), who often experience recurring injuries, residual feelings of instability, and abnormal neuromuscular patterns. Specifically, gait alterations are common in those with CAI and considered a contributing factor to poor long-term ankle joint health. Yet, there are no evidence-based gait-training protocols targeted to improve biomechanics, which may improve long-term outcomes related to ankle joint health and patient satisfaction.

This study protocol introduces a progressive auditory biofeedback (ABF) gait-training program aimed to improve short- and long-term lower extremity biomechanics and talar cartilage outcomes and reduce the frequency of ankle-giving-way episodes and recurring injuries.

This study is a multisite randomized controlled trial (RCT) with a target enrollment of 100 patients with CAI into a control group (n=50, 50%) or an ABF gait-training program (n=50, 50%). Both groups will complete a progressive 6-week (12-session) protocol comprising walking, ruck marching, and running on a treadmill. Lower extremity kinematics and kinetics, talar cartilage characteristics (via ultrasonography), self-perceived dysfunction and instability, and number of recurring sprains will be assessed prior to intervention, immediately after intervention, and 6 and 12 months postintervention. Finally, the frequency of ankle-giving-way episodes in the 6 months prior to intervention will be compared to the frequency of episodes at the 6- and 12-month time points to determine a longitudinal difference in ankle-giving-way episodes.

The study was funded in September 2024 and prospectively registered through ClinicalTrials.gov on March 10, 2025. The first participant was enrolled in May 2025. As of August 2026, 118 individuals had been recruited and 19 participants enrolled. Recruitment will remain open until September 2027, and study completion is expected in September 2028. Data processing is projected to continue through September 2028, with the final report published in June 2029.

This study will be the first RCT of ABF gait training to assess the immediate and long-term effects on lower extremity biomechanics, ankle joint health, and patient-reported outcomes in patients with CAI. Results from this study will advance the knowledge of long-term joint health that may be associated with poor outcomes post-LAS.

ClinicalTrials.gov NCT06868316; https://clinicaltrials.gov/study/NCT06868316.

DERR1-10.2196/107775.