Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
Healthy Volunteers
NCT06868316

Auditory Biofeedback Gait Training Individuals With Chronic Ankle Instability

Led by University of Kentucky · Updated on 2025-10-07

100

Participants Needed

2

Research Sites

170 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Auditory Biofeedback Gait Training Individuals With Chronic Ankle Instability

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Physically active adults able to run for at least 20 consecutive minutes
  • History of ankle sprain
  • At least two episodes of ankle "giving way" in the past 6 months
  • Answer "yes" to 5 or more questions on the Ankle Instability Instrument (AII)
  • Answer "yes" to 11 or more questions on the Identification of Functional Ankle Instability (IdFAI)
Not Eligible

You will not qualify if you...

  • An ankle sprain in the previous four weeks or other lower leg neuromusculoskeletal injury in the past 12 months
  • History of surgery in the lower extremity
  • Fracture to the lower extremity in the past 12 months or a fracture that required open-reduction internal fixation
  • History of neurological disease, vestibular or visual disturbance, or any pathology impairing 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

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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

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Research Team

D

Danielle M Torp, PhD, ATC

CONTACT

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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