JMIR Publications

ABSTRACT

Background:

Chronic ankle instability (CAI) develops in a large majority of lateral ankle sprain cases and 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.

Objective:

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

Methods:

This study is a multisite randomized controlled trial with a target enrollment of 100 individuals with CAI into a control condition (n=50) or the auditory biofeedback (n=50) gait training program. Both groups will complete a progressive 6-week (12 session) protocol consisting of 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, immediate post-intervention, and 6- and 12-month post-intervention. Finally, the frequency of ankle giving way episodes in the 6-months prior to the intervention will be compared to the frequency of episodes at the 6- and 12-month time points to see a longitudinal difference in giving way episodes.

Results:

The study was funded in September 2024, and data collection began in March 2025. As of manuscript submission, 18 participants were enrolled, data analysis is ongoing, and study completion is expected in September 2029.

Conclusions:

This study will be the first randomized controlled trial of auditory biofeedback 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 around long-term joint health that may be associated with poor outcomes following a lateral ankle sprain. Clinical Trial: Registered through the United States Library of Medicine through ClinicalTrials.gov: NCT06868316 on March 10th, 2025