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

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ClinicalTrials.gov Identifier: NCT03507803
Recruitment Status : Unknown
Verified May 2018 by Jay Hertel, PhD, ATC, University of Virginia.
Recruitment status was:  Recruiting
First Posted : April 25, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Jay Hertel, PhD, ATC, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Ankle Sprains Ankle Injuries Other: Gait Biofeedback Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (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.
Primary Purpose: Treatment
Official Title: Effects of Gait Biofeedback and Impairment-based Rehabilitation in Individuals With Chronic Ankle Instability
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Change from Baseline Range of motion [ Time Frame: Baseline, 4 weeks ]
    Ankle range of motion will be assessed using a plastic goniometer

  10. 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

  11. Change from Baseline Strength [ Time Frame: Baseline, 4 weeks ]
    Ankle and hip strength will be assessed using a handheld dynamometer in N

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507803


Contacts
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Contact: Rachel M Koldenhoven, MEd 434-924-6184 rmk7ye@virginia.edu

Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22904
Contact: Rachel M Koldenhoven, MEd    434-924-6184    rmk7ye@virginia.edu   
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Jay N Hertel, PhD University of Virginia
Publications:

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Responsible Party: Jay Hertel, PhD, ATC, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT03507803    
Other Study ID Numbers: 20446
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jay Hertel, PhD, ATC, University of Virginia:
Gait training
Walking
Additional relevant MeSH terms:
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Ankle Injuries
Leg Injuries
Wounds and Injuries