Optimizing Clinical Outcomes for Patients with Chronic Ankle Instability Using Foot Intensive Rehabilitation (FIRE)

The purpose of this randomized controlled trial is to determine if a novel Foot Intensive Rehabilitation (FIRE) protocol has the potential to create more effective clinical outcomes compared to SOC rehabilitation for patients with CAI. This study will use a multisite, single-blinded, randomized controlled trial design with data collected at the University of Kentucky, University of Virginia, and Naval Hospital Camp Pendleton. A total of 150 CAI patients (50 per site) will be randomly assigned to one of two groups (FIRE or SOC). Patients in both groups will complete a 6-week intervention composed of supervised and home exercises. Patients assigned to SOC will complete exercises focused on ankle strengthening, balance training and range of motion. Patients assigned to FIRE will complete a modified SOC program along with exercises focused on intrinsic foot muscle activation, dynamic foot stability, and plantar cutaneous stimulation. All participants will complete testing at baseline, postintervention, 6-month follow-up, 12-month follow-up, and 24-month follow-up to assess variables related to recurrent injury, sensorimotor function, and self-reported function. This study will compare the effects of a novel FIRE program to a SOC program on near- and long-term functional outcomes in patients with CAI. We posit that the FIRE intervention will reduce the occurrence of future ankle sprains and ankle giving way episodes and create clinically relevant improvements in sensorimotor function and self-reported disability beyond the SOC intervention alone. This study will also provide longitudinal evidence of FIRE or SOC for up to two years by assessing the ability of rehabilitation to reduce subsequent injuries, diminish CAI-related impairments, and improve patient-oriented measures of health which is critical for the immediate and long-term health of civilians and service members with this condition.