Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy ("KneeBRIGHT") Phase II
Phase: NA
Conditions: Osteo Arthritis Knee
Sponsor: University of Virginia

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Protocol ID: IRB-HSR# 21926 
 
 
 
 
 
Date: 11/01/2019 
 
Knee Biofeedback Rehabilitation Interface for 
Game-based Home Therapy ("KneeBRIGHT") 
Phase II 
 
 

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Protocol 
 
Osteoarthritis (OA) is the leading cause of disability in the United States. As osteoarthritis is associated 
with the lower limb muscle weakness, rehabilitation focused on quadriceps and other lower extremity 
muscle strengthening is a well-established treatment for patients with knee OA. However, patient 
adherence to exercise routines is low due to the lack of guidance regarding optimal protocols, and poor 
engagement during the repetitive routines that patients find tedious and boring. 
 
Long-term goal of this study is to improve knee OA outcomes through effective and motivating 
rehabilitation exercises. The Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy 
("KneeBRIGHT") system combines electromyography (EMG) biofeedback with video game therapy (VGT) 
to provide knee OA patients with an engaging, effective tool for conducting rehabilitation exercises at 
home. KneeBRIGHT aims to motivate patients with knee OA to conduct regular muscle strengthening 
exercise through an engaging, EMG-driven video game therapy. 
 
Participants with age from 40-75, with independent ambulation and with the diagnosis of knee OA made 
by x-ray and a score of at least 2 (out of 4) on the Kellgren-Lawrence OA radiographic classification 
system will be included in the study. Participants with psychiatric or cognitive impairment (e.g., 
dementia), symptomatic spine, hip, ankle, or foot disease other than OA that would interfere with 
assessment of the knee will be excluded. Participants with balance or vestibular disorders, peripheral 
neuropathy, skin conditions that prevent EMG electrode placement, prisoner, pregnant women (by 
report), non-English-speaking, individuals who are visually and/or hearing impaired will also be 
excluded. 
 
Eligible participants will be randomized to two groups: (1) KneeBRIGHT group; (2) Standard 
rehabilitation group. Both groups will undergo baseline and follow up assessment to measure the 
patient-reported outcomes, thigh muscle strength, and balance. Participants in both groups will undergo 
a 12-week program including 3 exercise sessions per week that includes a combination of in-person and 
at home sessions (Table 1).  
 
 
 
 
 
 

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Table 1 Study schedule for participants visits over 12 weeks 
 
Both groups will undergo same rehabilitation protocol which will begin with sessions supervised in the 
clinic by the study team physical therapist and gradually home sessions will be added. Participants in 
KneeBRIGHT group will perform the quadriceps strengthening exercises with the video-games based 
activities. The EMG biofeedback units and video game w/laptop will be provided to the subjects for 
home use. Subjects will receive instruction on how to apply the EMG biofeedback unit and use of the 
video game. KneeBRIGHT Game Activities consists of an introduction of the player to the virtual world 
and the missions, the player customizes the personal avatar and completes a series of calibration 
contractions and practice exercises to gain familiarity with the game controls. Through the EMG system, 
a player’s muscle contractions translate into physical movements of the avatar and control of vehicles 
within the virtual environment. Each quest-type challenge is designed to permit play in a seated, supine, 
supported standing, or freestanding position, based on an individual’s physical status. User interactions 
with the game incorporate knee extension exercises and functional movements that provide optimal 
therapeutic benefits.  
 
 
Participants in both groups will undergo combination of home and in clinic sessions. Protocol will start 
with six clinic visits in order to maximize familiarity with the exercise routines and equipment. Home 
sessions will be added after 2 weeks in rehabilitation (Table 2). The sessions will consist of warm up, 
strengthening, balance, precision and gentle stretching exercises. Strengthening exercises will be 
focused on quadriceps, hamstring, calf and gluteal muscles. Stretching exercises will be focused on 
quadriceps, hamstring and calf muscles. Progression will be guided by the rehabilitation principles and 
participants response to the exercise. The amount of these exercises will depend on how they make the 
subject feel. The rehabilitation program will allow the subject to increase the amount of exercise they 
can perform. Exercises will be limited if the subject feels discomfort. Overall, protocol will consist of 36 
sessions in total, 20 in clinic sessions and 16 home-based sessions. 
 
 
 
 
 
 
 
Visit 1 
(Screening) 
Visit 2 
(Baseline) 
Visit 3-38 
Follow-up 
Study Week 
 
0 
0 
1-12 
13 
Informed Consent 
 
x 
 
 
 
Review study eligibility 
x 
x 
 
 
Medical History 
x 
 
 
 
Strength, Balance & Endurance testing 
 
x 
 
 
Questionnaires 
 
x 
 
x 
Rehabilitation Exercises 
 
 
x 
x 

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Table 2 Weekly schedule for patients for in clinic and home-based therapy sessions 
 
One Hour Exercise Sessions 
 
In clinic session 
Home-based session 
Week 1 
3 
0 
Week 2 
3 
0 
Week 3 
2 
1 
Week 4 
2 
1 
Week 5 
2 
1 
Week 6 
2 
1 
Week 7 
1 
2 
Week 8 
1 
2 
Week 9 
1 
2 
Week 10 
1 
2 
Week 11 
1 
2 
Week 12 
1 
2 
TOTAL 
20 
16 
 
Pre and post intervention outcome measures will be compared to explore the effectiveness. Technology 
acceptance will also be studied in patients randomized to KneeBRIGHT group. 
 
Overall, KneeBRIGHT has the potential to significantly enhance OA rehabilitation by improving functional 
recovery through physical practice of specific, adaptive exercise and promoting adherence through fun 
games and performance feedback. Use of the KneeBRIGHT system in teletherapy may increase access to 
remote/underserved areas and extend the range of existing rehabilitation facilities. 
 
Statistical analysis 
Knee function assessed by composite KOOS score prior to the study will be compared to the KOOS score 
recorded post-intervention to test the primary hypothesis that patients conducting the KneeBRIGHT 
exercise will significantly improve knee function compared to the control group. Pre-intervention KOOS 
scores measures will be subtracted from the post-intervention scores to produce a set of delta values. 
These delta values will be analyzed via Analysis of Covariance (ANCOVA). A p≤0.05 decision rule will be 
utilized as the rejection criterion.  
 
Questionnaire results will be used to test the hypothesis that patients using the KneeBRIGHT system 
demonstrate increased levels of engagement compared to those conducting a conventional exercise 
routine. The questionnaire scores will be tallied to produce composite scores. These composite scores 
will be analyzed via a linear mixed model. A p 0.05 decision rule will be used as the null hypothesis 
rejection criterion. 
 
Timing data from the home visits will be analyzed by comparing the minutes of exercise with the 
KneeBRIGHT system to minutes of exercise with the standard exercise regimen in the control group to 

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test the hypothesis that exercise duration is greater with the KneeBRIGHT system. Mean usage time on 
each system will be analyzed via Student’s paired t-test, with p 0.05 as the null hypothesis rejection 
criterion.