Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy (KneeBRIGHT) in Patients with Knee Osteoarthritis: A Protocol for Evaluating the KneeBRIGHT System via Randomized, Controlled Clinical Trial

Background: Patients with knee osteoarthritis who seek physical therapy interventions often struggle with compliance to prescribed exercise regimens, resulting in reduced benefits of physical therapy programs. More engaging and technology-enabled interventions incorporating real-time biofeedback and gamification have shown promise in improving exercise adherence and outcomes. Objective: The subject research study aims to evaluate whether the KneeBRIGHT system, an electromyographic biofeedback-based video gaming system, improves exercise adherence and functional outcomes compared to standard physical therapy. We hypothesize that the incorporation of a real-time biofeedback and gamification system will be more engaging and fun, and in turn, will increase exercise adherence and lead to better clinical outcomes. Methods: This is a prospective, single-blinded, randomized control trial conducted at a single academic center in collaboration with 5 local physical therapy clinics. Sixty patients between 40 and 75 years old with radiographically diagnosed knee osteoarthritis will be randomized to an 8-week structured rehabilitation program that includes a combination of both clinic and home exercise sessions with or without the KneeBRIGHT system. OUTCOMES: The primary outcome measured will be pre-to-post changes in patient reported outcomes (KOOS), with secondary outcomes measured in functional performance tests, protocol adherence, and technology acceptance assessments. Trial Registration: ClinicalTrials.gov, NCT06090097. URL: https://clinicaltrials.gov/study/NCT06090097 .