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A Patient-Driven Rehabilitation System to Improve Upper Limb Amputee Outcomes

Award Number: R44HD072668
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2012
PERIOD OF PERFORMANCE END DATE: 12/31/2017

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A Patient-Driven Rehabilitation System to Improve Upper Limb Amputee Outcomes - DESCRIPTION (provided by applicant): A patient-driven rehabilitation system to improve upper limb amputee outcomes. The goal of our research program is to develop technological solutions that restore function for upper extremity amputees. For these individuals, one of the most promising developments in the past decade has been the introduction of fully dexterous terminal devices. However, an effective and intuitive control strategy has remained elusive. Myoelectric control works well for one or two degree-of-freedom devices, but is not effective when dealing with a large number of movement classes (such as when attempting to discriminate amongst "hand open", "index finger point", "fine pinch", and so on). With this background, several groups pioneered the use of pattern recognition algorithms. Near perfect results have been demonstrated in the laboratory setting, but to date such performance has not been translated into real-world clinical impact. We believe that a critical missing piece is effective patient training. During Phase I, we developed such a methodology. MyoTrain v1.0 is a desktop computer based virtual-hand training system, including hardware and software components. The hardware consists of a compressive silicone cuff embedded with eight electrode pairs, an EMG amplifier, and a data-acquisition card contained in a desktop PC. The software includes a virtual prosthesis model and multi-channel EMG pattern-recognition software. The system was evaluated in a study involving four trans-radial amputees. Control of nine different movement classes was achieved with a Movement Completion Percentage of 99.0% (versus 70.8% at baseline). Furthermore, excellent accuracy was maintained over 8 hours without requiring any classifier retraining. We now propose a Phase II effort involving translation of our clinical prototype into a medical device cleared by the United States Food and Drug Administration: MyoTrain v2.0. As part of this journey from lab to clinic to home, our Phase II plan involves the development of modules for telerehabilitation as well as for immersive virtual reality and task-based training. This work is based on direct feedback we have received from amputees and clinicians using MyoTrain v1.0, and we will continue to interact with these groups during development of MyoTrain 2.0 to yield the best possible clinical outcome. We will then conduct a study over a period of two months to evaluate clinical impact. Our primary outcome measure is the Southhampton Hand Assessment Procedure, but we will also employ the Box and Blocks test as well as other measures including three different validated survey instruments. We believe that our Phase II program will yield a device with FDA 510(k) Premarket Clearance which will, for the first time, enable upper-extremity amputees to unlock the full potential of today's dexterous prosthesis.


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: 2018 ( Subtotal = $0 )
2018	2015	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	1101 E 33RD ST STE E305	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	3	5/1/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2015	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	1101 E 33RD ST STE E305	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	3	7/12/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2015 ( Subtotal = $701,859 )
2015	2015	INFINITE BIOMEDICAL TECHNOLOGIES LLC	2352 Huntington Dr	Pasadena	CA	91108	LOS ANGELES	USA	Child Health and Human Development Extramural Research	000	3	6/16/2015	NON-COMPETING CONTINUATION	$701,859
														Subtotal = $701,859

Issue Date FY: 2014 ( Subtotal = $777,926 )
2014	2014	INFINITE BIOMEDICAL TECHNOLOGIES LLC	2352 Huntington Dr	Pasadena	CA	91108	LOS ANGELES	USA	Child Health and Human Development Extramural Research	000	2	7/21/2014	COMPETING CONTINUATION	$777,926
														Subtotal = $777,926

Grand Total All Awards = $1,479,785

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A Patient-Driven Rehabilitation System to Improve Upper Limb Amputee Outcomes

Award Number: R44HD072668

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/01/2012

PERIOD OF PERFORMANCE END DATE: 12/31/2017

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