Auditory Biofeedback Gait Training Individuals With Chronic Ankle Instability

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.

Conditions

• Ankle Sprains
• Ankle Injuries and Disorders

Interventions

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.

Sponsors & Collaborators

• University of Kentucky

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-05-27

Primary Completion

2028-06-30

Completion

2028-09-30

Countries

• United States

Study Locations