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

Primary Purpose

Ankle Sprains, Ankle Injuries

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Gait Biofeedback
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprains focused on measuring Gait training, Walking

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Gait Biofeedback

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from Baseline Ankle Frontal Plane Angle During Gait
Ankle frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.

Secondary Outcome Measures

Change from Baseline Ankle Sagittal Plane Angle During Gait
Ankle sagittal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Change from Baseline Ankle Transverse Plane Angle During Gait
Ankle transverse plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Change from Baseline Hip Frontal Plane Angle During Gait
Hip frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Change from Baseline Hip Sagittal Plane Angle During Gait
Hip sagittal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Change from Baseline Hip Transverse Plane Angle During Gait
Hip transverse plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Change from Baseline Knee Frontal Plane Angle During Gait
Knee frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Change from Baseline Knee Sagittal Plane Angle During Gait
Knee sagittal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Change from Baseline Knee Transverse Plane Angle During Gait
Knee transverse plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Change from Baseline Range of motion
Ankle range of motion will be assessed using a plastic goniometer
Change from Baseline Balance
Single limb balance with eyes open and eye closed conditions will be assessed using a Tekscan pressure mat
Change from Baseline Strength
Ankle and hip strength will be assessed using a handheld dynamometer in N
Change from Baseline Foot and Ankle Ability Measure (FAAM)
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.
Change from Baseline Foot and Ankle Ability Measure (FAAM) Sport
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.
Change from Baseline Identification of Functional Ankle Instability (IdFAI)
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.
Change from Baseline International Physical Activity Questionnaire
The International Physical Activity Questionnaire total score will be assessed. Higher scores represent increased physical activity.
Change from Baseline Tampa Scale if Kinesiophobia (TSK)
The Tampa Scale if Kinesiophobia (TSK) total score will be assessed. Lower scores indicate less kinesiophobia. Higher scores indicate higher amount of kinesiophobia.
Change from Baseline Visual Analog Scale (VAS)
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.
The Global Rating of Change (GROC) Score
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.
Change from Baseline Physical Activity
Fitbit Charge HR monitors will be worn by all participants for 4 weeks. Average daily steps will be analyzed.

Full Information

First Posted
February 15, 2018
Last Updated
May 10, 2018
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT03507803
Brief Title
Effects of Gait Biofeedback and Impairment-based Rehabilitation in Individuals With Chronic Ankle Instability
Official Title
Effects of Gait Biofeedback and Impairment-based Rehabilitation in Individuals With Chronic Ankle Instability
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprains, Ankle Injuries
Keywords
Gait training, Walking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized at the baseline visit to either the intervention or control group. The intervention group will receive gait biofeedback. Participants will remain within their designated allocation for the entire study.
Masking
Care Provider
Masking Description
Clinician involved in rehabilitation will not know if participant has been enrolled in the gait biofeedback arm or the control (no biofeedback) arm.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gait Biofeedback
Arm Type
Experimental
Arm Description
This group will receive audiovisual feedback about the position of their foot during walking. Feedback will be provided over 8 total sessions.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This arm will not receive any audiovisual feedback about the position of their foot during walking.
Intervention Type
Other
Intervention Name(s)
Gait Biofeedback
Intervention Description
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 Information:
Title
Change from Baseline Ankle Frontal Plane Angle During Gait
Description
Ankle frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Time Frame
Baseline, 4 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline Ankle Sagittal Plane Angle During Gait
Description
Ankle sagittal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Time Frame
Baseline, 4 weeks
Title
Change from Baseline Ankle Transverse Plane Angle During Gait
Description
Ankle transverse plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Time Frame
Baseline, 4 weeks
Title
Change from Baseline Hip Frontal Plane Angle During Gait
Description
Hip frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Time Frame
Baseline, 4 weeks
Title
Change from Baseline Hip Sagittal Plane Angle During Gait
Description
Hip sagittal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Time Frame
Baseline, 4 weeks
Title
Change from Baseline Hip Transverse Plane Angle During Gait
Description
Hip transverse plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Time Frame
Baseline, 4 weeks
Title
Change from Baseline Knee Frontal Plane Angle During Gait
Description
Knee frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Time Frame
Baseline, 4 weeks
Title
Change from Baseline Knee Sagittal Plane Angle During Gait
Description
Knee sagittal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Time Frame
Baseline, 4 weeks
Title
Change from Baseline Knee Transverse Plane Angle During Gait
Description
Knee transverse plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Time Frame
Baseline, 4 weeks
Title
Change from Baseline Range of motion
Description
Ankle range of motion will be assessed using a plastic goniometer
Time Frame
Baseline, 4 weeks
Title
Change from Baseline Balance
Description
Single limb balance with eyes open and eye closed conditions will be assessed using a Tekscan pressure mat
Time Frame
Baseline, 4 weeks
Title
Change from Baseline Strength
Description
Ankle and hip strength will be assessed using a handheld dynamometer in N
Time Frame
Baseline, 4 weeks
Title
Change from Baseline Foot and Ankle Ability Measure (FAAM)
Description
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.
Time Frame
Baseline, 4 weeks
Title
Change from Baseline Foot and Ankle Ability Measure (FAAM) Sport
Description
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.
Time Frame
Baseline, 4 weeks
Title
Change from Baseline Identification of Functional Ankle Instability (IdFAI)
Description
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.
Time Frame
Baseline, 4 weeks
Title
Change from Baseline International Physical Activity Questionnaire
Description
The International Physical Activity Questionnaire total score will be assessed. Higher scores represent increased physical activity.
Time Frame
Baseline, 4 weeks
Title
Change from Baseline Tampa Scale if Kinesiophobia (TSK)
Description
The Tampa Scale if Kinesiophobia (TSK) total score will be assessed. Lower scores indicate less kinesiophobia. Higher scores indicate higher amount of kinesiophobia.
Time Frame
Baseline, 4 weeks
Title
Change from Baseline Visual Analog Scale (VAS)
Description
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.
Time Frame
Baseline, 4 weeks
Title
The Global Rating of Change (GROC) Score
Description
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.
Time Frame
4 weeks
Title
Change from Baseline Physical Activity
Description
Fitbit Charge HR monitors will be worn by all participants for 4 weeks. Average daily steps will be analyzed.
Time Frame
Baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel M Koldenhoven, MEd
Phone
434-924-6184
Email
rmk7ye@virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay N Hertel, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel M Koldenhoven, MEd
Phone
434-924-6184
Email
rmk7ye@virginia.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20926721
Citation
Waterman BR, Owens BD, Davey S, Zacchilli MA, Belmont PJ Jr. The epidemiology of ankle sprains in the United States. J Bone Joint Surg Am. 2010 Oct 6;92(13):2279-84. doi: 10.2106/JBJS.I.01537.
Results Reference
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20351590
Citation
Delahunt E, Coughlan GF, Caulfield B, Nightingale EJ, Lin CW, Hiller CE. Inclusion criteria when investigating insufficiencies in chronic ankle instability. Med Sci Sports Exerc. 2010 Nov;42(11):2106-21. doi: 10.1249/MSS.0b013e3181de7a8a.
Results Reference
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PubMed Identifier
21460069
Citation
Mok KM, Fong DT, Krosshaug T, Engebretsen L, Hung AS, Yung PS, Chan KM. Kinematics analysis of ankle inversion ligamentous sprain injuries in sports: 2 cases during the 2008 Beijing Olympics. Am J Sports Med. 2011 Jul;39(7):1548-52. doi: 10.1177/0363546511399384. Epub 2011 Apr 1. No abstract available.
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Effects of Gait Biofeedback and Impairment-based Rehabilitation in Individuals With Chronic Ankle Instability

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