Effects of Gait Biofeedback and Impairment-based Rehabilitation in Individuals With Chronic Ankle Instability

May 10, 2018 updated by: Jay Hertel, PhD, ATC, University of Virginia
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study will require 10 visits for all participants. Both groups will participate in baseline and follow-up gait assessments involving walking on a treadmill at 1.34 m/s. Follow-up visits will be conducted within 72 hours of the participant's final rehabilitation session. Using a rigid cluster marker setup, reflective markers will be placed on the upper back, sacrum, and bilaterally on the thigh, shank, rearfoot, and forefoot. A 5-minute familiarization period will be completed to ensure participants are comfortable and walking as normally as possible. Following the familiarization period, 1-minute of continuous gait data will be collected. The data collected during baseline and follow-up gait assessments will be used to analyze the primary and secondary outcome measures for kinematics. Participants will also complete the patient reported outcomes (FAAM ADL & Sport Subscale) at the baseline and follow-up visits.

Impairment-based Rehabilitation:

Four weeks of supervised rehabilitation (8 sessions) will be provided to both groups. This rehabilitation paradigm has been previously reported by Donovan and Hertel. Impairment-based rehabilitation involves identifying and treating deficits in 4 broad domains including range of motion (ROM), strength, balance, and functional exercises by using an "asses, treat, re-assess" approach. Previously reported intervention methods will be used in this study. The clinician administering the rehabilitation will be blinded to the subjects' intervention group status.

Intervention:

Gait training using visual feedback for frontal plane ankle position at initial contact (IC) will be projected onto a screen in front of the treadmill.

Gait Training Protocol:

The goal of this protocol is to improve the position of the ankle at IC using visual feedback gait training over the course of 4 weeks. The intervention group will participate in 2 sessions of gait training per week for 4 weeks using intermittent feedback described by Noehren et al. The Motion Monitor is a software system uses body movements to provide visual feedback to the participant by using information from retroreflective markers on the body that are captured by the cameras. The software will use the position of the rearfoot marker cluster in relation to the shank marker cluster to determine the rearfoot inversion angle at IC and provide visual biofeedback information for the next step. Visual feedback in the shape of a line will be displayed as an image projected onto a screen in front of the treadmill representing frontal plane inversion angle. The line will adjust (similar to a teeter-totter) according to the position of the foot and will change color accordingly. When the ankle position is too inverted, the line will turn red and an audio tone will be heard by the participant. When the ankle position is in a good position, the line will turn green and the tone will not be heard.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22904
        • Recruiting
        • University of Virginia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.
No Intervention: Control
This arm will not receive any audiovisual feedback about the position of their foot during walking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Ankle Frontal Plane Angle During Gait
Time Frame: Baseline, 4 weeks
Ankle frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Baseline, 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Ankle Sagittal Plane Angle During Gait
Time Frame: Baseline, 4 weeks
Ankle sagittal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Baseline, 4 weeks
Change from Baseline Ankle Transverse Plane Angle During Gait
Time Frame: Baseline, 4 weeks
Ankle transverse plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Baseline, 4 weeks
Change from Baseline Hip Frontal Plane Angle During Gait
Time Frame: Baseline, 4 weeks
Hip frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Baseline, 4 weeks
Change from Baseline Hip Sagittal Plane Angle During Gait
Time Frame: Baseline, 4 weeks
Hip sagittal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Baseline, 4 weeks
Change from Baseline Hip Transverse Plane Angle During Gait
Time Frame: Baseline, 4 weeks
Hip transverse plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Baseline, 4 weeks
Change from Baseline Knee Frontal Plane Angle During Gait
Time Frame: Baseline, 4 weeks
Knee frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Baseline, 4 weeks
Change from Baseline Knee Sagittal Plane Angle During Gait
Time Frame: Baseline, 4 weeks
Knee sagittal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Baseline, 4 weeks
Change from Baseline Knee Transverse Plane Angle During Gait
Time Frame: Baseline, 4 weeks
Knee transverse plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Baseline, 4 weeks
Change from Baseline Range of motion
Time Frame: Baseline, 4 weeks
Ankle range of motion will be assessed using a plastic goniometer
Baseline, 4 weeks
Change from Baseline Balance
Time Frame: Baseline, 4 weeks
Single limb balance with eyes open and eye closed conditions will be assessed using a Tekscan pressure mat
Baseline, 4 weeks
Change from Baseline Strength
Time Frame: Baseline, 4 weeks
Ankle and hip strength will be assessed using a handheld dynamometer in N
Baseline, 4 weeks
Change from Baseline Foot and Ankle Ability Measure (FAAM)
Time Frame: Baseline, 4 weeks
The Foot and Ankle Ability Measure (FAAM) for Activities of Daily Living total score will be assessed. The score will be assessed as a percentage. Scores closer to 100% indicate full ankle function. Lower percentage scores indicate ankle dysfunction.
Baseline, 4 weeks
Change from Baseline Foot and Ankle Ability Measure (FAAM) Sport
Time Frame: Baseline, 4 weeks
The Foot and Ankle Ability Measure (FAAM) Sport total score will be assessed. The score will be assessed as a percentage. Scores closer to 100% indicate full ankle function. Lower percentage scores indicate ankle dysfunction.
Baseline, 4 weeks
Change from Baseline Identification of Functional Ankle Instability (IdFAI)
Time Frame: Baseline, 4 weeks
The Identification of Functional Ankle Instability (IdFAI) total score will be assessed. Raw scores will be assessed. Higher scores indicate more ankle dysfunction. Lower scores indicate better ankle function.
Baseline, 4 weeks
Change from Baseline International Physical Activity Questionnaire
Time Frame: Baseline, 4 weeks
The International Physical Activity Questionnaire total score will be assessed. Higher scores represent increased physical activity.
Baseline, 4 weeks
Change from Baseline Tampa Scale if Kinesiophobia (TSK)
Time Frame: Baseline, 4 weeks
The Tampa Scale if Kinesiophobia (TSK) total score will be assessed. Lower scores indicate less kinesiophobia. Higher scores indicate higher amount of kinesiophobia.
Baseline, 4 weeks
Change from Baseline Visual Analog Scale (VAS)
Time Frame: Baseline, 4 weeks
The Visual Analog Scale (VAS) total score will be assessed. The range will be from 0 to 100. Higher score indicates worse ankle pain. Lower score indicates better ankle pain.
Baseline, 4 weeks
The Global Rating of Change (GROC) Score
Time Frame: 4 weeks
The Global Rating of Change (GROC) score will be assessed at the follow-up visit. A positive and higher score indicates the patient feels better than they did when they began the study. A score of 0 indicates no change from baseline. A negative and lower score indicates the patient feels worse than they did when they began the study.
4 weeks
Change from Baseline Physical Activity
Time Frame: Baseline, 4 weeks
Fitbit Charge HR monitors will be worn by all participants for 4 weeks. Average daily steps will be analyzed.
Baseline, 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Jay N Hertel, PhD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2018

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

February 15, 2018

First Submitted That Met QC Criteria

April 19, 2018

First Posted (Actual)

April 25, 2018

Study Record Updates

Last Update Posted (Actual)

May 16, 2018

Last Update Submitted That Met QC Criteria

May 10, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20446

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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