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

Award Number: R44AG062069
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2018
PERIOD OF PERFORMANCE END DATE: 11/30/2024

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $951,526 )
2024	2024	BARRON ASSOCIATES, INC.	1410 SACHEM PL	CHARLOTTESVILLE	VA	22901	ALBEMARLE	USA	Aging Research	000	5	11/9/2023	NON-COMPETING CONTINUATION	$951,526
2024	2024	BARRON ASSOCIATES, INC.	1410 SACHEM PL	CHARLOTTESVILLE	VA	22901	ALBEMARLE	USA	Aging Research	001	5	8/21/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $951,526

Issue Date FY: 2023 ( Subtotal = $885,288 )
2023	2023	BARRON ASSOCIATES INC	1410 SACHEM PL	CHARLOTTESVILLE	VA	22901	ALBEMARLE	USA	Aging Research	001	4	12/13/2022	COMPETING CONTINUATION	$885,288
2023	2019	BARRON ASSOCIATES, INC.	1410 SACHEM PL	CHARLOTTESVILLE	VA	22901	ALBEMARLE	USA	Aging Research	000	3	11/9/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $885,288

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	BARRON ASSOCIATES, INC.	1410 SACHEM PL STE 202	CHARLOTTESVILLE	VA	22901	ALBEMARLE	USA	Aging Research	000	3	6/4/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $832,695 )
2019	2019	BARRON ASSOCIATES, INC.	1410 SACHEM PL STE 202	CHARLOTTESVILLE	VA	22901	ALBEMARLE	USA	Aging Research	000	3	5/31/2019	NON-COMPETING CONTINUATION	$795,332
2019	2019	BARRON ASSOCIATES, INC.	1410 SACHEM PL STE 202	CHARLOTTESVILLE	VA	22901	ALBEMARLE	USA	Aging Research	001	3	7/2/2019	NON-COMPETING CONTINUATION	$37,363
														Subtotal = $832,695

Issue Date FY: 2018 ( Subtotal = $653,867 )
2018	2018	BARRON ASSOCIATES, INC.	1410 SACHEM PL STE 202	CHARLOTTESVILLE	VA	22901	ALBEMARLE	USA	Aging Research	000	2	9/26/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$653,867
														Subtotal = $653,867

Grand Total All Awards = $3,323,376

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

Award Number: R44AG062069

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/30/2018

PERIOD OF PERFORMANCE END DATE: 11/30/2024

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