Recruiting

Gait Training with AudFB

Sponsor:

Danielle Torp

Code:

NCT06868316

Conditions

Ankle Sprains

Ankle Injuries and Disorders

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Walking

Rucking

Running

Study Details

Brief 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

Study ID

NCT06868316

Start date

May 27, 2025

Status verified date

Jul, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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)
  • History of ankle sprain
  • 2 episodes of "giving way" in the past 6-months
  • must answer "yes" to =5 questions on the Ankle Instability Instrument (AII) and =11 on the Identification of Functional Ankle Instability (IdFAI)

Exclusion Criteria:

  • an ankle sprain in the previous four weeks or lower extremity neuromusculoskeletal injury other than to the ankle in the last 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 other pathology that would impair sensorimotor performance or gait
  • current participation in a formal ankle joint rehabilitation program
  • a concussion in the last 12 months
  • report a cardiovascular, metabolic, or renal disease, or signs and symptoms that suggest such condition or have been told by a medical provider not to engage in vigorous physical activity (such as running).

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

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.

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.

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.

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 ]
  • Change in lower extremity biomechanics - maximum force [ Time Frame: baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention ]
  • Change in lower extremity biomechanics - pressure-time integral [ Time Frame: baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention ]
  • Change in lower extremity biomechanics - force-time integral [ Time Frame: baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention ]
  • Change in Talar cartilage deformation [ Time Frame: baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention ]
  • Change in self perceived ankle instability [ Time Frame: Baseline, 6-Month Post-Intervention, and 12-Month Post-Intervention ]
  • Change in self perceived foot and ankle disability [ Time Frame: Baseline, 6-Month Post-Intervention, and 12-Month Post-Intervention ]

Central Contacts and Locations

Central contacts

Danielle M Torp, PhD, ATC

18593239835danielle.torp@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Principal Investigator:

Danielle Torp, PhD, ATC

More Information

Sponsor

Danielle Torp

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Danielle Torp on 2026-07-21.