Biofeedback Gait Training for Ankle Injury

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Kentucky

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with chronic ankle instability (CAI) due to syndesmotic injury or a sprained ankle. Participants should be able to complete gait training sessions and follow-up tests. Specific eligibility criteria are not provided, but typically include age range, health status, and the severity of CAI.

Inclusion Criteria

Physically active adults (defined as participants reporting a score of =4 on the National Aeronautics and Space Administration (NASA) Activity Instrument and indicating they can run for at least 20 consecutive minutes)

Must answer 'yes' to =5 questions on the Ankle Instability Instrument (AII) and =11 on the Identification of Functional Ankle Instability (IdFAI)

My knee has given way twice in the last 6 months.

+1 more

Exclusion Criteria

Current participation in a formal ankle joint rehabilitation program

A concussion in the last 12 months

I sprained my ankle in the last 4 weeks or had another leg injury in the past year.

+4 more

Participant Groups

The study examines if auditory biofeedback (AudFB) during gait training over six weeks can improve walking biomechanics, reduce ankle cartilage damage, and decrease episodes of the ankle giving way in people with CAI compared to a control group without AudFB.

2Treatment groups

Experimental Treatment

Active Control

Group I: auditory biofeedback (AudFB) gait trainingExperimental Treatment3 Interventions

AudFB group will wear the Loadsol Pros in-shoe insoles with the audible noise emitted from the iOS device

Group II: ControlActive Control3 Interventions

Control group will wear the Loadsol Pros in-shoe insoles, with the auditory biofeedback function disabled