Effects of Gait Retraining With Auditory Feedback

Ankle Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04302961
• Other study ID #: 19-0552
• Status: Completed
• Phase: Early Phase 1
• Start date: October 5, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2023
• Source: University of North Carolina, Charlotte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Inversion Sprain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UNC Charlotte	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Charlotte

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Changes from baseline in static balance	Static balance will be measured via a force plate	Immediate post-intervention, 1-week post-intervention
Secondary	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