Knee Biofeedback Rehabilitation Through Game Therapy

Study Overview
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Brief Summary
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The goal of this study is to learn about the effect of video-game based rehabilitation exercise for patients with knee osteoarthritis. The main question the study aims to answer is: do patients who exercise with the game have better functional outcomes and engagement compared to patients who do conventional exercise? Participants will complete 10 weeks of physical therapy exercise sessions that focus on quadriceps strengthening. Two sessions per week will be conducted in the clinic, and one session will be conducted at home each week. The interventional group will conduct all exercises using the KneeBRIGHT EMG sensors and game software. The control group will conduct all exercises following a standard physical therapy regimen. Researchers will compare knee function and engagement between the group who uses the game, and the group who does conventional exercise.

Detailed Description
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The KneeBRIGHT game system will be evaluated in a 10-week single-blinded randomized controlled trial. The goals of this study are to: (1) assess improvements in functional outcomes following an exercise regimen conducted by KneeBRIGHT compared to conventional exercise; and (2) evaluate patient engagement during unsupervised, home-based exercises with and without the KneeBRIGHT software. Over the course of the study period, the knee OA participants will conduct physical therapy sessions with the physical therapist (PT) who enrolled them. The exercise regimen will implement each PT's standard of care, consisting of two weekly clinic sessions and one weekly home exercise session, for 10 weeks. Knee OA participants will be randomly assigned (via block randomization for each PT) to use either the KneeBRIGHT system for both clinic and home exercise, or to receive standard care with conventional exercise routines. Participants will conduct functional exercise assessments on study intake and again on study completion. Participants will also complete questionnaires focused on exercise engagement on study completion.

Official Title
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Knee-Biofeedback Rehabilitation Interface for Game-based Home Therapy

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: KneeBRIGHT System
* Other: Control Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis via x-ray, with a score of at least 2 (out of 4) on the Kellgren-Lawrence OA scoring system; independent ambulation without assistive device Exclusion Criteria: individuals who have psychiatric or cognitive impairment (e.g., dementia) that interferes with their ability to follow instructions or provide voluntary consent; symptomatic spine, hip, ankle, or foot disease other than OA that would interfere with assessment of the knee.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KneeBRIGHT Group<br>The interventional group will conduct all exercises during the 10-week therapy regimen using the KneeBRIGHT electromyogram sensors and game software. | Device: KneeBRIGHT System<br>* The KneeBRIGHT system includes electromyogram sensors and video game software that leads participants through physical therapy exercise.<br>|
| Active Comparator: Control Group<br>The control group will conduct all exercises following a standard physical therapy regimen. | Other: Control Exercise<br>* The control group will complete a 10-week regimen of conventional PT exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Osteoarthritis Outcome Score | A multi-dimensional assessment that classifies knee outcomes into five categories: pain, symptoms, activities of daily living (ADL), sport, and quality of life | After 10 weeks (study completion) | 
| Timed get-up-and-go score | In the timed up and go (TUG) test, subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again. | After 10 weeks (study completion) | 
| 6-minute walk test | The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. | After 10 weeks (study completion) | 
| Quadriceps strength | Quadriceps strength will be measured by recording isokinetic knee extension torque as measured by a dynamometer | After 10 weeks (study completion) | 
| Patient Activation Model Scores | The Patient Activation Model (PAM) is an established, highly reliable, questionnaire that reflects a developmental model of patient engagement with their healthcare regimens | After 10 weeks (study completion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient technology acceptance | Participants will complete a questionnaire, designed based on the established Technology Acceptance Model to assess their level of technology acceptance. | After 10 weeks (study completion) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee osteoarthritis, physical therapy, rehabilitation