Actively Recruiting
Optimizing Retention on Duty in Patients With Chronic Ankle Instability Using Auditory Biofeedback Gait Training: A Multisite Randomized Controlled Trial
Led by University of Kentucky · Updated on 2025-10-07
100
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of gait training with auditory biofeedback (AudFB) on walking biomechanics, ankle joint health, and patient-centered outcomes in adults with chronic ankle instability (CAI). This randomized clinical controlled trial aims to determine whether a 6-week AudFB gait training program improves lower extremity biomechanics, reduces cartilage deformation, and decreases episodes of ankle giving-way compared to a control group. The study is motivated by the high rate of chronic ankle instability after ankle sprains and the lack of effective gait training interventions to prevent long-term complications such as ankle osteoarthritis. Participants will be randomly assigned to either the AudFB group or a control group with a 1:1 ratio. Both groups will complete 12 supervised gait training sessions over 6 weeks, each lasting about 25 minutes, including walking, rucking with a weighted backpack, and running. The AudFB group will receive real-time auditory feedback from plantar force sensors in their shoes, while the control group will wear the same insoles without the auditory feedback. Both groups will wear neutral athletic shoes and wireless force insoles for consistency. Participants will attend testing sessions before and after the intervention, and then at 6 and 12 months post-intervention. These sessions will assess lower extremity biomechanics during walking, rucking, and running, measure talar cartilage deformation with ultrasound, and record ankle giving-way episodes along with self-reported symptom severity. The study aims to provide short- and long-term data on the impact of AudFB gait training on ankle health and function, with a total follow-up duration of one year after treatment.
CONDITIONS
Brief Title
Auditory Biofeedback Gait Training Individuals With Chronic Ankle Instability
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Physically active adults who can run for at least 20 consecutive minutes
- History of ankle sprain
- At least 2 episodes of ankle "giving way" in the past 6 months
- Must answer "yes" to 5 or more questions on the Ankle Instability Instrument (AII)
- Must answer "yes" to 11 or more questions on the Identification of Functional Ankle Instability (IdFAI)
You will not qualify if you...
- An ankle sprain in the previous 4 weeks or other lower extremity neuromusculoskeletal injury in the last 12 months (other than ankle)
- History of surgery in the lower extremity
- Fracture to the lower extremity in the past 12 months or fracture requiring open-reduction internal fixation
- History of neurological disease, vestibular or visual disturbance, or other conditions affecting sensorimotor performance or gait
- Current participation in a formal ankle joint rehabilitation program
- Concussion in the last 12 months
- Cardiovascular, metabolic, or renal disease, or symptoms suggesting such conditions, or medical advice against vigorous physical activity such as running
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants complete a 6-week gait training program consisting of 12 supervised sessions. The program includes walking, rucking, and running conditions designed to improve gait biomechanics and ankle health.
12 sessions over 6 weeks, each lasting approximately 25 minutes
Duration - 12 months
Participants return for assessments to evaluate the long-term effects of the gait training on walking, running biomechanics, ankle cartilage health, and symptoms.
3 visits at immediately post-intervention, 6 months, and 12 months post-intervention
Trial Site Locations
Total: 2 locations
1
University of Kentucky
Lexington, Kentucky, United States, 40506
Actively Recruiting
2
University of North Carolina at Charlotte
Charlotte, North Carolina, United States, 28223
Not Yet Recruiting
Research Team
D
Danielle M Torp, PhD, ATC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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