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OpenTrials
Completed

NCT Number: NCT04302961

Effects of Gait Retraining With Auditory Feedback

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.

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Key information

Conditions

Ankle Injuries Ankle Inversion Sprain Leg Injuries Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UNC Charlotte

Charlotte, North Carolina, 28223, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auditory Feedback

Other

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

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. 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).

Secondary outcomes

  1. Changes from baseline in static balance

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

    Static balance will be measured via a force plate

  2. 2. Changes from baseline in plantar pressure during forward lunges, lateral hops, and a step-down

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

    Plantar pressure during forward lunges, lateral hops, and a step-down will be recorded with an in-shoe insole system.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Charlotte

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2020
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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