Effects of Gait Retraining With Auditory Feedback

Effects of Gait Retraining With Auditory Feedback on Biomechanics and Ankle Joint Health in Individuals With Chronic Ankle Instability

There is evidence to support individuals with chronic ankle instability (CAI) have altered gait biomechanics which may lead to re-injury and poor patient outcomes. Currently, there are no interventions specifically targeting these abnormal gait biomechanics. Evidence supports the use of an external focus of attention feedback to promote motor learning and retention. The overall purpose of randomized clinical trial is to determine the effects of a 2-week (8 session) gait retraining protocol using an auditory external feedback instrument can (1) alter biomechanics during functional tasks (walking, step-down, lunge, lateral hops, and balance) (2) improve ankle cartilage measures and (3) improve patient-reported outcome measures.

Study Overview

• Status: Completed
• Conditions: Ankle Injuries; Ankle Inversion Sprain
• Intervention / Treatment: Other: Auditory Feedback; Other: No Feedback

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28223
      • UNC Charlotte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• History of at least one ankle sprain
• Index ankle sprain > 12 months prior to study enrollment
• Most recent ankle sprain > 12 weeks prior to study enrollment
• Score >10 on the Identification of Functional Ankle Instability (IdFAI) survey.
• Score <95% on the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living and a <85% on the Sport subscales
• Be physically active by participating in some form of physical activity for at least 20 min per day, three times per week.

Exclusion Criteria:

• History of ankle surgery
• History of other musculoskeletal injuries within the past 6 weeks
• Any condition affecting plantar pressure distribution
• Neurological or vestibular disorders affecting balance
• Current/previous self-reported disability due to lower extremity pathology that may adversely affect neuromuscular function

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Auditory Feedback; Participants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving auditory feedback.	Other: Auditory Feedback; Participants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving no feedback. Participants will be instructed to walk on a treadmill at their desired pace in a manner that does not cause the auditory tool to elicit a noise.
Active Comparator: No Feedback; Participants will complete 8 sessions over a 2-week period of walking on a treadmill without receiving feedback.	Other: No Feedback; Participants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving no feedback. Participants will be instructed to walk on a treadmill at their desired pace in a manner that they perceive to be their normal walking speed and mechanics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in lower extremity kinetics during walking	Plantar pressure and center of pressure trajectory measured with an in-shoe plantar pressure system	Immediate post-intervention, 1-week post-intervention
Changes from baseline in talar cartilage deformation before and after walking	Talar cartilage thickness and cross-sectional area will be measured with an diagnostic ultrasound imaging system	Immediate post-intervention, 1-week post-intervention
Changes from baseline in self-reported ankle function	Changes from baseline in self-reported function as measured by the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living and Sport questionnaire. Scores range from 100% (no decrease in function) to 0% (complete loss of function).	Immediate post-intervention, 1-week post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in static balance	Static balance will be measured via a force plate	Immediate post-intervention, 1-week post-intervention
2. Changes from baseline in plantar pressure during forward lunges, lateral hops, and a step-down	Plantar pressure during forward lunges, lateral hops, and a step-down will be recorded with an in-shoe insole system.	Immediate post-intervention, 1-week post-intervention

Collaborators and Investigators

• Sponsor: University of North Carolina, Charlotte

Publications and helpful links

General Publications

• Torp DM, Thomas AC, Hubbard-Turner T, Donovan L. Plantar pressure profile during walking is associated with talar cartilage characteristics in individuals with chronic ankle instability. Clin Biomech (Bristol, Avon). 2022 May;95:105656. doi: 10.1016/j.clinbiomech.2022.105656. Epub 2022 Apr 27.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries
• Other Study ID Numbers: 19-0552

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No