Recruiting
Phase 3

Gait Biofeedback & Rehabilitation

Sponsor:

University of Virginia

Code:

NCT03507803

Conditions

Ankle Sprains

Ankle Injuries

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

Interventions

Gait Biofeedback

Study Details

Brief summary:

Individuals with chronic ankle instability (CAI) have demonstrated altered gait patterns. Gait training may be necessary to address these alterations as protocols focusing solely on strength or balance have not been shown to impact walking gait. Biofeedback about the foot position during walking may help improve gait biomechanics. The purpose is to determine whether a 4-week rehabilitation program that includes biofeedback has beneficial effects on self-reported function and ankle gait kinematics compared to rehabilitation alone in people with CAI. The design is a single-blinded randomized controlled trial. Participants will complete baseline self-reported function questionnaires and walking gait trials and then be randomized to complete 4- weeks of supervised rehabilitation with or without audiovisual biofeedback. Follow up emails will ask for participant information about ankle health and to complete questionnaires about their ankle for 6 months and 12 months after completing rehabilitation.

Conditions

Ankle Sprains

Ankle Injuries

Study ID

NCT03507803

Start date

Feb 15, 2018

Status verified date

May, 2018

Completion date

Mar, 2020

Anticipated

Primary completion date

Mar, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • >1 Ankle Sprain (>12 months prior)
  • Physically active (>1.5 hr/week)
  • > 10 on Identification of Functional Ankle Instability (IdFAI)
  • < 90 Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL)
  • < 85 FAAM Sport

Exclusion Criteria:

  • Hx of LE fracture
  • Hx of LE surgery
  • Hx of ankle sprain within last 6 weeks
  • Participating in physical therapy for ankle
  • Multiple Sclerosis
  • Marfan's Syndrome
  • Lumbosacral Radiculopathy
  • Ehlers-Danlos Syndrome
  • Diabetes Mellitus
  • Pregnant (self-reported)
  • Unable to provide informed consent

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Gait Biofeedback

This group will receive audiovisual feedback about the position of their foot during walking. Feedback will be provided over 8 total sessions.

no intervention: Control

This arm will not receive any audiovisual feedback about the position of their foot during walking.

Interventions

Gait Biofeedback

Feedback will appear on screen in front of participants during walking. If their foot is too inverted (determined by researcher) the object on the screen will turn red and an audio tone will be heard. If the participant corrects the foot position, the object will turn green and the audio tone will not be heard.

Primary outcome measure

  • Change from Baseline Ankle Frontal Plane Angle During Gait [ Time Frame: Baseline, 4 weeks ]

Central Contacts and Locations

Central contacts

Rachel M Koldenhoven, MEd

434-924-6184rmk7ye@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22904

Contacts

Rachel M Koldenhoven, MEd

434-924-6184rmk7ye@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

May 16, 2018

Last verified

May, 2018

Keywords

  • Gait training
  • Walking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2018-05-16.