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Knee-Biofeedback Rehabilitation Interface for Game-based Home Therapy (KneeBRIGHT)

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44AG062069-04A1
Agency Tracking Number: R44AG062069
Amount: $885,288.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIA
Solicitation Number: PA21-260
Timeline
Solicitation Year: 2021
Award Year: 2023
Award Start Date (Proposal Award Date): 2022-12-15
Award End Date (Contract End Date): 2024-11-30
Small Business Information
1410 Sachem Place
Charlottesville, VA 22901-2496
United States
DUNS: 120839477
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 EILEEN KREPKOVICH
 (434) 973-1215
 krepkovich1n@bainet.com
Business Contact
 B. PARKER
Phone: (434) 973-1215
Email: barron@bainet.com
Research Institution
N/A
Abstract

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.

* Information listed above is at the time of submission. *

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