Auditory Biofeedback Gait Training Individuals With Chronic Ankle Instability

Conditions

• Ankle Injuries and Disorders
• Ankle Sprains

Eligibility Criteria

Sex

ALL

Age

18 Years - 45 Years

Healthy Volunteers

Accepted

Interventions

• Walking — OTHER
  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.
• Rucking — OTHER
  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.
• Running — OTHER
  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.

Study Details

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.

Key Dates

Start date

May 27, 2025

Status verified

Sep 2025

Primary completion

Jun 30, 2028

Completion

Sep 30, 2028

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Control
  Control group will wear the Loadsol Pros in-shoe insoles, with the auditory biofeedback function disabled
• Experimental: auditory biofeedback (AudFB) gait training
  AudFB group will wear the Loadsol Pros in-shoe insoles with the audible noise emitted from the iOS device

Primary Outcome Measure

Change in lower extremity biomechanics - peak pressure [ Time Frame: baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention ]

Central Contacts

• Danielle M Torp, PhD, ATC
  18593239835
  [email protected]

Locations (2)

Find similar trials in Lexington, KY

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