A Phase 3 interventional study of Gait Biofeedback in Ankle Sprains and Ankle Injuries, sponsored by University of Virginia. Status unknown at 1 site in United States. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2018-05-16.
Sponsored by University of Virginia · Phase 3, Interventional, and Treatment
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.
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.
362 studies on the registry are indexed under Ankle Injuries; 72 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 281 interventional studies indexed under Ankle Injuries.
Browse Ankle Injuries studies →University of Virginia is the lead sponsor of 673 studies on the registry; 139 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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Exclusion Criteria:
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
This arm will not receive any audiovisual feedback about the position of their foot during walking.
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.
Change from Baseline Ankle Frontal Plane Angle During Gait
Ankle frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Time frame: Baseline, 4 weeks
Change from Baseline Ankle Sagittal Plane Angle During Gait
Ankle sagittal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Time frame: Baseline, 4 weeks
Change from Baseline Ankle Transverse Plane Angle During Gait
Ankle transverse plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Time frame: Baseline, 4 weeks
Change from Baseline Hip Frontal Plane Angle During Gait
Hip frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Time frame: Baseline, 4 weeks
Change from Baseline Hip Sagittal Plane Angle During Gait
Hip sagittal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Time frame: Baseline, 4 weeks
Change from Baseline Hip Transverse Plane Angle During Gait
Hip transverse plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Time frame: Baseline, 4 weeks
Change from Baseline Knee Frontal Plane Angle During Gait
Knee frontal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Time frame: Baseline, 4 weeks
Change from Baseline Knee Sagittal Plane Angle During Gait
Knee sagittal plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Time frame: Baseline, 4 weeks
Change from Baseline Knee Transverse Plane Angle During Gait
Knee transverse plane angle will be assessed throughout the gait cycle using ensemble curves analysis.
Time frame: Baseline, 4 weeks
Change from Baseline Range of motion
Ankle range of motion will be assessed using a plastic goniometer
Time frame: Baseline, 4 weeks
Change from Baseline Balance
Single limb balance with eyes open and eye closed conditions will be assessed using a Tekscan pressure mat
Time frame: Baseline, 4 weeks
Change from Baseline Strength
Ankle and hip strength will be assessed using a handheld dynamometer in N
Time frame: Baseline, 4 weeks
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.
Time frame: Baseline, 4 weeks
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.
Time frame: Baseline, 4 weeks
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.
Time frame: Baseline, 4 weeks
Change from Baseline International Physical Activity Questionnaire
The International Physical Activity Questionnaire total score will be assessed. Higher scores represent increased physical activity.
Time frame: Baseline, 4 weeks
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.
Time frame: Baseline, 4 weeks
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.
Time frame: Baseline, 4 weeks
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.
Time frame: 4 weeks
Change from Baseline Physical Activity
Fitbit Charge HR monitors will be worn by all participants for 4 weeks. Average daily steps will be analyzed.
Time frame: Baseline, 4 weeks
Plan to share: No
Started Feb 2018 (actual). Primary completion is estimated for Mar 2019, 13 months after the start.
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