Skip to main content
Clinical Trials/NCT04302961
NCT04302961
Completed
Early Phase 1

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

University of North Carolina, Charlotte1 site in 1 country28 target enrollmentOctober 5, 2020

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Ankle Injuries
Sponsor
University of North Carolina, Charlotte
Enrollment
28
Locations
1
Primary Endpoint
Changes from baseline in talar cartilage deformation before and after walking
Status
Completed
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 5, 2020
End Date
June 30, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of North Carolina, Charlotte
Responsible Party
Principal Investigator
Principal Investigator

Luke Donovan

Assistant Professor

University of North Carolina, Charlotte

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes from baseline in talar cartilage deformation before and after walking

Time Frame: Immediate post-intervention, 1-week post-intervention

Talar cartilage thickness and cross-sectional area will be measured with an diagnostic ultrasound imaging system

Changes from baseline in self-reported ankle function

Time Frame: Immediate post-intervention, 1-week post-intervention

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).

Changes from baseline in lower extremity kinetics during walking

Time Frame: Immediate post-intervention, 1-week post-intervention

Plantar pressure and center of pressure trajectory measured with an in-shoe plantar pressure system

Secondary Outcomes

  • Changes from baseline in static balance(Immediate post-intervention, 1-week post-intervention)
  • 2. Changes from baseline in plantar pressure during forward lunges, lateral hops, and a step-down(Immediate post-intervention, 1-week post-intervention)

Study Sites (1)

Loading locations...

Similar Trials