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Principal Investigator: Eileen T. Krepkovich
Organization: BARRON ASSOCIATES, INC.
Fiscal Year: 2024
Award: $951,526
Funding agency: National Institute on Aging
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 and sustained impact on public health by increasing knee OA patient
adherence to home exercise and thereby reducing pain and restoring physical function.
Terms: <Access to Care><Address><Adherence><Analgesia Tests><Biofeedback><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><Certification><Clinic><Clinical Trials><Cloud Service><Combined Modality Therapy><Computer software><Control Groups><Degenerative Arthritis><Degenerative polyarthritis><Designing computer software><Development><Devices><Documentation><EMG biofeedback><Electrodes><Electromyography><Equilibrium><Evidence based practice><Exercise><Exercise based rehabilitation><Exercise routine><Feedback><HIPAA><Health Insurance Portability and Accountability Act><Health Services Accessibility><Home><Home environment><Insurance><Investigators><Joint Diseases><Kennedy Kassebaum Act><Knee><Knee Osteoarthritis><Label><Marketing><Medical Rehabilitation><Modeling><Monitor><Motivation><Multimodal Therapy><Multimodal Treatment><New Device Approvals><Nociception Tests><Notification><Osteoarthritis><Osteoarthrosis><Outcome><PL 104-191><PL104-191><Pain><Pain Assessment><Pain Measurement><Pain measure><Painful><Participant><Patient Compliance><Patients><Performance><Phase><Physiatric Procedure><Physical Function><Physical Medicine Procedure><Physical Therapeutics><Physical therapy><Physiotherapy><Production><Protocol><Protocols documentation><Provider><Psychology><Public Health><Public Law 104-191><Questionnaires><Randomized><Randomized Controlled Clinical Trials><Randomized, Controlled Trials><Recovery of Function><Regimen><Rehabilitation><Rehabilitation therapy><Research Personnel><Researchers><Resistance><Risk><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Safety><Secure><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Social Support System><Software><Software Design><Specific qualifier value><Specified><Study models><Support System><System><Technology><Teletherapy><Testing><Time><Training><Translational Research><Translational Science><Travel><United States><United States Health Insurance Portability and Accountability Act><Validation><Video Games><access to health services><access to services><access to treatment><accessibility to health services><arthropathic><arthropathies><arthropathy><availability of services><balance><balance function><care access><clinical practice><clinical relevance><clinically relevant><combination therapy><combined modality treatment><combined treatment><compare to control><comparison control><control trial><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><cost><dashboard><data analytics dashboard><data dashboard><degenerative joint disease><design><design validation><design verification><designing><developmental><disability><effective therapy><effective treatment><electromyographic biofeedback><evidence base><exercise program><exercise regimen><exercise rehabilitation><experience><fitness program><functional improvement><functional outcomes><functional recovery><functional status><health service access><health services availability><homes><hypertrophic arthritis><improve function><improved><improved functional outcomes><innovate><innovation><innovative><joint disorder><knee OA><knee joint OA><knee joint osteoarthritis><multi-modal therapy><multi-modal treatment><muscle strengthening><next generation><online app><osteoarthritic><pain assay><pain reduction><participant engagement><patient adherence><patient cooperation><patient engagement><programs><prototype><quadriceps><quadriceps muscle><randomisation><randomization><randomized control clinical trial><randomized control trial><randomly assigned><reduce pain><rehab therapy><rehabilitative><rehabilitative exercise><rehabilitative therapy><remote health monitoring><remote patient monitoring><resistant><sensor><service availability><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><strength training><success><telehealth><thermal biofeedback><tool><translation research><translational investigation><treatment access><trend><under served area><under served geographic area><under served location><under served region><underserved area><underserved geographic area><underserved location><underserved region><usability><validations><videogame><virtual world><visual dashboard><visualization dashboard><walking pace><walking speed><web app><web application><web based app><web based application><web based dashboard><web dashboard><wireless>