SBIR-STTR Award

Knee-Biofeedback Rehabilitation Interface for Game-Based Home Therapy (KneeBRIGHT)
Award last edited on: 1/31/2024

Sponsored Program
STTR
Awarding Agency
NIH : NIA
Total Award Amount
$3,548,301
Award Phase
2
Solicitation Topic Code
866
Principal Investigator
Eileen Krepkovich

Company Information

Barron Associates Inc (AKA: BAI)

1410 Sachem Place Suite 202
Charlottesville, VA 22901
   (434) 973-1215
   sales@barron-associates.com
   www.barron-associates.com

Research Institution

University of Virginia

Phase I

Contract Number: 1R41AR067562-01A1
Start Date: 9/1/2015    Completed: 8/31/2016
Phase I year
2015
Phase I Amount
$224,925
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 patients with knee OA to conduct regular muscle strengthening exercise through an engaging, EMG-driven video game 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 targeted and progressive exercise routines. Importantly, these exercises are presented to the patient in the form of fun and engaging games to promote a positive experience and encourage continued adherence. Problem to be Addressed: OA is the leading cause of disability in the U.S. Rehabilitation through quadriceps strengthening is a well-established treatment for patients with OA of the knee, but necessities of cost containment and lack of access to rehabilitation centers result in many patients being advised to perform these exercises at home. When left unsupervised, patients are faced with two challenges: (1) lack of guidance of trained clinicians who, in the clinic, optimally adjust protocols and resistance levels for functional improvement, and (2) lack of engagement during repetitive exercises that most individuals find boring. Long-Term Goal: Improve knee OA rehabilitation outcomes through effective and efficient delivery of care. Phase I Hypotheses: The STTR Phase I program will test the hypotheses that patients performing exercise routines using KneeBRIGHT will: (1) achieve equivalent muscle activations compared to a conventional EMG biofeedback system; and (2) exhibit increased engagement compared to the conventional system. Phase I Summary: Barron Associates, Inc. (award-winning innovators in video game therapy) has partnered with the University of Virginia for this STTR Phase I program to demonstrate feasibility and usability of the KneeBRIGHT system. The specific objectives of the Phase I program are to: (1) develop the Phase I prototype KneeBRIGHT EMG modules; (2) develop the Phase I KneeBRIGHT game software; (3) perform pilot testing of muscle activation and engagement levels (when compared to a conventional system) with knee OA patients in a laboratory environment; and (4) analyze the results of the pilot study. Successful prototype development along with the pilot study in Phase I will lay the foundation for the Phase II effort, which will include development of a commercial product including an interactive patient-clinician interface and formal evaluation of the KneeBRIGHT system's efficacy for improving adherence and clinical outcomes. Impact: The system will have a significant overall impact on public health by increasing patient adherence to home exercise routines and thereby reducing pain symptoms, restoring physical function, and ultimately improving quality of life for patients with knee OA.

Public Health Relevance Statement:


Public Health Relevance:
The proposed Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy ("KneeBRIGHT") system aims to motivate patients with knee osteoarthritis to conduct regular muscle strengthening exercise through an engaging, EMG-driven video game therapy. KneeBRIGHT promises to enhance rehabilitation by: (1) increasing functional recovery through physical practice of evidence-based exercise routines; (2) promoting adherence through fun games and performance feedback; (3) providing a low-cost option for at-home therapy; (4) creating reliable tracking mechanisms for patient activity and functional status; and (5) increasing access to care in remote, underserved areas.

NIH Spending Category:
Arthritis; Assistive Technology; Behavioral and Social Science; Bioengineering; Clinical Research; Osteoarthritis; Pain Conditions - Chronic; Pain Research; Physical Rehabilitation; Rehabilitation

Project Terms:
Address; Adherence (attribute); Area; arthropathies; Award; base; Biofeedback; care delivery; Clinic; Clinical; clinical efficacy; Compliance behavior; Computer software; cost; Cost Control; Degenerative polyarthritis; Development; disability; Disease; Electrodes; Electromyography; Environment; Evaluation; Evidence based practice; Exercise; Exhibits; experience; Feedback; Foundations; functional improvement; functional status; Generations; Goals; Health Care Costs; Health Services Accessibility; Home environment; improved; Individual; innovation; Knee; Knee Osteoarthritis; Laboratories; Left; Medical; Motivation; Muscle; Outcome; Pain; Patients; Performance; Phase; Physical Function; Pilot Projects; Play; Population; pressure; programs; Protocols documentation; prototype; public health medicine (field); public health relevance; Quadriceps Muscle of the Thigh; Quality of life; Questionnaires; Recovery of Function; Rehabilitation Centers; Rehabilitation Outcome; Rehabilitation therapy; Research; Resistance; sensor; Small Business Technology Transfer Research; success; Symptoms; System; Technology; Testing; Time; tool; Training; Universities; usability; Video Games; Virginia; Wireless Technology

Phase II

Contract Number: 9R44AG062069-02A1
Start Date: 9/30/2018    Completed: 5/31/2020
Phase II year
2018
(last award dollars: 2024)
Phase II Amount
$3,323,376

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 patients with knee OA to conduct regular muscle strengthening exercise through an engaging, EMG-driven video game 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 games 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 treatment for patients with OA of the knee, 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. Long-Term Goal: Improve knee OA outcomes through effective and motivating rehabilitation exercises. Phase I Results: During the Phase I effort, a prototype KneeBRIGHT system was developed and verified in a laboratory setting. The feasibility testing with 19 knee OA patients demonstrated statistically significant increases in muscle activation, engagement levels, and duration of voluntary exercise during the KneeBRIGHT exercises when compared with exercises conducted with a conventional EMG biofeedback system. Phase II Hypotheses: The Phase II program will test the hypotheses that patients performing exercise routines using KneeBRIGHT will: (1) achieve superior muscle strength gain compared to a conventional EMG biofeedback protocol; and (2) exhibit increased adherence compared to the conventional system. Phase II Summary: Barron Associates (award-winning innovators in video game therapy) has partnered with the University of Virginia for this SBIR Phase II program to demonstrate efficacy and user acceptance of the KneeBRIGHT system. The specific objectives of the Phase II program are to: (1) develop the Phase II commercial KneeBRIGHT EMG modules; (2) develop the Phase II commercial KneeBRIGHT game software with adaptive exercise protocols and expanded game activities; (3) develop a provider dashboard to enable clinicians to monitor patient performance remotely; and (4) perform efficacy testing of muscle strength, functional improvement (via Knee Osteoarthritis Outcome Score), and adherence (when compared to a conventional system) with knee OA patients in a 12-week clinical trial. Impact: The system will have a significant overall impact on public health by increasing patient adherence to home exercise and thereby reducing pain symptoms and restoring physical function to knee OA patients.

Public Health Relevance Statement:
PROJECT NARRATIVE The proposed Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy (“KneeBRIGHT”) system aims to motivate patients with knee osteoarthritis to engage in regular muscle strengthening exercise through an engaging, EMG-driven video game therapy. KneeBRIGHT promises to enhance rehabilitation by: (1) increasing functional recovery through physical practice of evidence-based exercise routines; (2) promoting adherence through fun games and real-time performance feedback; (3) providing a low-cost option for at- home therapy; (4) creating reliable tracking mechanisms for patient adherence and functional status; and (5) increasing access to care in remote, underserved areas.

NIH Spending Category:
Aging; Arthritis; Assistive Technology; Behavioral and Social Science; Bioengineering; Chronic Pain; Clinical Research; Clinical Trials and Supportive Activities; Osteoarthritis; Pain Research; Patient Safety; Physical Activity; Physical Rehabilitation; Rehabilitation

Project Terms:
Activities of Daily Living; Address; Adherence; Architecture; Area; arthropathies; Award; base; Biofeedback; Certification; Clinic; Clinical Trials; Compliance behavior; Computer software; cost; dashboard; Degenerative polyarthritis; design; Development; disability; Disease; efficacy testing; Electrodes; Electromyography; evidence base; Evidence based practice; Exercise; exercise regimen; exercise rehabilitation; Exercise Therapy; Exhibits; experience; Feasibility Studies; Feedback; functional improvement; functional outcomes; functional status; Goals; Health Services Accessibility; Home environment; improved; innovation; Insurance; Interview; Knee; Knee Osteoarthritis; Laboratories; Measures; Modeling; Motivation; Muscle; muscle strength; Outcome; Pain; pain reduction; pain symptom; patient engagement; Patient Monitoring; Patients; Performance; Phase; Physical Function; Production; programs; Protocols documentation; prototype; Provider; Public Health; quadriceps muscle; Recovery of Function; Rehabilitation therapy; Resistance; Risk; Safety; sensor; Small Business Innovation Research Grant; strength training; success; Symptoms; System; Technology; Teletherapy; Testing; Time; tool; Torque; Training; Travel; United States; Universities; usability; Validation; Video Games; Virginia; Wireless Technology