PROJECT SUMMARY/ABSTRACT Significance: The Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy (“KneeBRIGHT”) system combines electromyography (EMG) biofeedback with video game therapy (VGT) to provide knee osteoarthritis (OA) patients with an engaging, effective tool for conducting rehabilitation exercises at home. KneeBRIGHT aims to motivate OA patients to conduct regular muscle strengthening exercise through an engaging, EMG-driven virtual worlds therapy. The system combines wireless EMG electrodes that are convenient for patients to use in a home setting with software that provides automated guidance through evidence-based, progressive exercise routines. Importantly, these exercises are presented to the patient in the form of fun and engaging activities to promote a positive experience and encourage continued adherence. Problem to be Addressed: OA is the leading cause of disability in the United States. Rehabilitation through quadriceps strengthening is a well-established, effective treatment for knee OA but patient adherence to exercise routines is low due to lack of guidance regarding optimal protocols and lack of engagement during the repetitive routines that patients find tedious and boring. Unsupervised, home-based exercise is particularly challenging. Innovative, engaging solutions are needed to enable and facilitate home participation, especially given the increased the use of telehealth due to the COVID19 pandemic. Phase II Results: The Phase II effort successfully developed a full-featured KneeBRIGHT system and deployed it in a 10-week randomized, controlled trial with knee OA patients. Participants using the KneeBRIGHT system for exercise increased their home exercise session participation by 20% compared to the control group. The study also demonstrated very positive usability ratings and positive trends in strength and balance outcomes. Phase IIB Program Summary: The proposed Phase IIB effort will yield a commercial KneeBRIGHT system supporting home-based physical therapy for knee OA. New developments will include: game enhancements to expand exercise options and device compatibility; upgraded sensor features; a secure provider dashboard web application for monitoring and guiding therapy; and HIPAA compliant cloud services integration. Pursuit of federal regulatory approval for the new device will include documentation of safety, creation of a user’s guide and other FDA labeling, and completion of actions supporting premarket notification. To establish acceptance by physical therapy practitioners, a network of multiple knee OA physical therapy providers will participate in a randomized, controlled clinical trial. An innovative provider-as-investigator study model will streamline translation of research to clinical practice. The clinical trial will evaluate the ability of the KneeBRIGHT system, as prescribed by a variety of PTs, to achieve clinically relevant outcomes. Impact: The system will have a substantial an...