Effects of Gait Biofeedback and Impairment-based Rehabilitation in Individuals With Chronic Ankle Instability
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| ClinicalTrials.gov Identifier: NCT03507803 |
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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
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ankle Sprains Ankle Injuries | Other: Gait Biofeedback | Phase 3 |
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 (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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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No Intervention: Control
This arm will not receive any audiovisual feedback about the position of their foot during walking.
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Change from Baseline Range of motion [ Time Frame: Baseline, 4 weeks ]Ankle range of motion will be assessed using a plastic goniometer
- 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
- Change from Baseline Strength [ Time Frame: Baseline, 4 weeks ]Ankle and hip strength will be assessed using a handheld dynamometer in N
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years to 30 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| Contact: Rachel M Koldenhoven, MEd | 434-924-6184 | rmk7ye@virginia.edu |
| United States, Virginia | |
| University of Virginia | Recruiting |
| Charlottesville, Virginia, United States, 22904 | |
| Contact: Rachel M Koldenhoven, MEd 434-924-6184 rmk7ye@virginia.edu | |
| Principal Investigator: | Jay N Hertel, PhD | University of Virginia |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Gait training Walking |
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Ankle Injuries Leg Injuries Wounds and Injuries |