RECRUITING

Auditory Biofeedback Gait Training Individuals With Chronic Ankle Instability

Conditions

Ankle Sprains Ankle Injuries and Disorders

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Optimizing Retention on Duty in Patients With Chronic Ankle Instability Using Auditory Biofeedback Gait Training: A Multisite Randomized Controlled Trial

Quick Facts

Study Start:2025-05-27

Study Completion:2028-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06868316

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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)	* 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).

Inclusion Criteria

Exclusion 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)

* 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).

Contacts and Locations

Study Contact

Danielle M Torp, PhD, ATC

CONTACT

18593239835

danielle.torp@uky.edu

Study Locations (Sites)

University of Kentucky

Lexington, Kentucky, 40506

United States

University of North Carolina at Charlotte

Charlotte, North Carolina, 28223

United States

Collaborators and Investigators

Sponsor: University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-27

Study Completion Date2028-09

Study Record Updates

Study Start Date2025-05-27

Study Completion Date2028-09

Terms related to this study

Additional Relevant MeSH Terms

Ankle Sprains
Ankle Injuries and Disorders