Auditory Biofeedback Gait Training Individuals With Chronic Ankle Instability

NCT06868316 | Recruiting

• 2 other identifiers: 98018CDMRP-OR230135
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (7)

• Change in lower extremity biomechanics - peak pressure

  The assessment will consist of a 45-minute treadmill loading protocol with 15 minutes of each: walking, running, and ruck marching.

  baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention

• Change in lower extremity biomechanics - maximum force

  The assessment will consist of a 45-minute treadmill loading protocol with 15 minutes of each: walking, running, and ruck marching.

  baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention

• Change in lower extremity biomechanics - pressure-time integral

  The assessment will consist of a 45-minute treadmill loading protocol with 15 minutes of each: walking, running, and ruck marching.

  baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention

• Change in lower extremity biomechanics - force-time integral

  The assessment will consist of a 45-minute treadmill loading protocol with 15 minutes of each: walking, running, and ruck marching.

  baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention

• Change in Talar cartilage deformation

  Participants will be placed in a long-sitting position on a table for 30 minutes to limit the influence of the preceding activity on resting thickness volume. After the offloading period, participants will be positioned with their back flat against a wall, the test limb with the knee flexed at 90°, and their foot flat on a table. A 12-MHz linear ultrasound probe will be positioned transversely between the medial and lateral malleoli and adjusted until the talar cartilage appears to be maximum reflected. Images will be taken and averaged to assess structural and functional components of ankle joint health.

  baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention

• Change in self perceived ankle instability

  Ankle instability will be measured by the Cumberland Ankle Instability Tool (CAIT). This tool is designed to capture the severity of CAI through the 9-item scale focusing on the degree of difficulty in performing various physical activities due to the ankle. Scores range from 0 to 30, with a higher score indicative of higher stability

  Baseline, 6-Month Post-Intervention, and 12-Month Post-Intervention

• Change in self perceived foot and ankle disability

  The Foot and Ankle Disability Index (FADI) is a region-specific patient-reported outcome designed to assess functional limitations during activities of daily living and sports-related activities in participants with foot and ankle pathologies

  Baseline, 6-Month Post-Intervention, and 12-Month Post-Intervention

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Other: Walking; Other: Rucking; Other: Running

auditory biofeedback (AudFB) gait training

EXPERIMENTAL

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

Other: Walking; Other: Rucking; Other: Running

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.

Control; auditory biofeedback (AudFB) gait training

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.

Control; auditory biofeedback (AudFB) gait training

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.

Control; auditory biofeedback (AudFB) gait training

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Kentucky: lead

Study Sites (2)

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

University of North Carolina at Charlotte

Charlotte, North Carolina, 28223, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Ankle Injuries; Disease

Interventions

Walking; Running

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Central Study Contacts

Danielle M Torp, PhD, ATC

CONTACT

18593239835; danielle.torp@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 10, 2025
• Study Start: May 27, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)