NCT06868316

Auditory Biofeedback Gait Training Individuals With Chronic Ankle Instability

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Kentucky · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Background: Ankle injuries account for the highest musculoskeletal injuries among conventional and special warfare combatants. In the civilian population, 40% of lateral ankle sprain patients will develop chronic ankle instability (CAI). If the same frequency is true in military settings, then up to 36,800 service members develop CAI annually. CAI contributes to the total number of medically non-available service members, creates a substantial economic burden, impacts the quality of duty-relevant task performance, and generates a large population of service members who require long-term care after retirement. There are no evidence-based gait training interventions for patients with CAI despite abnormal biomechanical patterns leading to recurring injuries linked to ankle osteoarthritis (OA) development. Overall, the current rehabilitation strategies are insufficient for preventing complications following an ankle sprain. Hypothesis/Objectives: The overall objective of this study is to examine the effects of gait training with auditory feedback (AudFB) on gait biomechanics, ankle joint health, and patient-centered outcomes. Our central hypothesis is that a 6-week (12 sessions) gait training program with AudFB will lead to short and long-term improvements in walking, rucking, and running biomechanics, talar cartilage deformation patterns, giving way episodes and severity of symptoms. Specific Aims: Aim 1: Determine if a 6-week gait training with AudFB improves lower extremity biomechanics compared to a Control condition in participants with CAI. Aim 2: Determine if a 6-week gait training with AudFB reduces talar cartilage deformation compared to a Control condition in participants with CAI. Aim 3: Determine if a 6-week gait training with AudFB reduces ankle giving-way episodes and severity of CAI symptoms relative to a Control condition in participants with CAI. Study Design: Specific Aims 1-3 will be addressed using a single-blinded, multi-site randomized controlled trial design with data collected at the University of Kentucky (UK) and University of North Carolina at Charlotte (UNC Charlotte) (Figure 3). Patients with CAI will be randomized to the AudFB or Control group at a 1:1 allocation ratio (n=100; 50 UK and 50 UNC Charlotte). Participants will report to the UK Sports Medicine Research Institute or the UNC Charlotte Biodynamics Research Laboratory to complete outcomes for Specific Aims 1-3 at Baseline, Post-Intervention, and 6- and 12-Month Post-Intervention sessions, which will record: 1) lower extremity biomechanics during walking, rucking, and running, 2) talar articular cartilage deformation via ultrasonography, and 3) ankle giving way and patient-reported outcomes of CAI symptom severity. The AudFB group and Control group will complete 12 sessions of supervised gait training over 6 weeks and follow the same condition-based progression design. Each session will last roughly 25 minutes and begin with 10 minutes of walking followed by 15 minutes of the designated condition for that session (walking, rucking, or running). The AudFB group will receive real-time biofeedback derived from plantar forces of the lateral foot. The control group will be instructed to walk comfortably. Both groups will wear standard neutral athletic shoes and wireless in-shoe force insoles during every intervention session for standardization of testing procedures. Impact and Military Benefit: The Investigators expect participants with CAI in the AudFB group will exhibit improvements in patient-centered outcomes and subsequent clinician-centered outcomes regarding biomechanics and ankle joint health. These findings will signal that our novel AudFB gait training protocol is critical to short- and long-term quality of life in patients with CAI. This study will provide a short-term impact by providing clinicians with an easily accessible and feasible tool to implement gait training to optimize return to duty in service members with CAI history. The long-term impact of this study will be related to the expansion of the rehabilitation paradigm by providing an evidence-based gait training protocol that has the potential to mitigate the early onset of ankle OA.

Conditions

• Ankle Sprains
• Ankle Injuries and Disorders

Interventions

Type	Name	Description
OTHER	Walking	Weeks 1-2, Sessions 1-4: The first condition will be walking with the speed self-selected based on "a comfortable pace to walk for exercise" as determined during the Baseline testing session. This speed will be held constant for the 10-minute walking portion prior to each condition but will be progressed for the remaining walking condition sessions (Sessions 2-4). The minimum speed will be limited to 1 mph.
OTHER	Rucking	Weeks 3-4, Session 5-8: The second condition will require participants to wear a standard rucksack equal to 20% of their body weight (minimum ruck weight: 15 pounds, maximum ruck weight: 45 pounds). The initial speed used during this condition will be self-selected based on "a comfortable pace to walk for exercise carrying this weight" as determined during the Baseline testing session.
OTHER	Running	Weeks 5-6, Sessions 9-12: The final condition is running. The self-selected running pace will be chosen as a pace that the participant can "sustain for a leisure run for 20 minutes," as determined at the Baseline testing session. Participants will only run for the 15-minute condition period.

Timeline

• Start date: 2025-05-27
• Primary completion: 2028-06-01
• Completion: 2028-09-01
• First posted: 2025-03-10
• Last updated: 2025-10-07

Locations

2 sites across 1 country: United States