795,000 Americans experience a CVA yearly. More intensive rehabilitation early sub-acute post-CVA was found to produce better recovery. The first objective is the development of a relatively low- cost medical device with small clinical footprint. The BrightArm C (BAC) is a compact robotic table with bimanual hand controllers that track full 3D arm movement, measure finger grasp and extension, arm pronation/supination, and monitor health through biosensors. UE movements will be induced during interaction with virtual games. The second objective is to determine the efficacy of BAC for the in-patient and outpatient therapy continuum compared to standard of care. We expect that the new integrative therapy, when added to conventional rehabilitation will result in higher functioning individuals for the same time period.
SPECIFIC AIMS 1) Develop the BrightArm C robotic table with novel UE controllers and custom integrative games. Conduct a usability and a feasibility study with Roosevelt Care Center on inpatients sub-acute post- CVA. 2) Longitudinal randomized clinical study of 24 subjects sub-acute post-CVA, inpatients and then outpatients at Kessler Institute for Rehabilitation. Enroll 24 caregivers and obtain their periodic feedback. METHODS 1) Complete mechanical and electronic design of the robotic table, construct a prototype, preform operational testing and validate UE tracking over the entire table. 2) Design and fabricate forearm controllers measuring grasp strength and finger extension, forearm pronation/supination and integrated biosensors. Develop arm position modeling and conduct reliability testing. 3) Interface UE movements captured by hand controllers with an enhanced game library. Integrative games will train motor function and cognitive domains of executive function, memory, focusing and language comprehension. 4) Conduct a usability evaluation on elderly volunteers. 5) Conduct a feasibility study with 6 inpatients early sub-acute post-CVA, showing good technology acceptance and clinical benefit. 6) Build and deploy two BrightArm C systems at Kessler Institute for Rehabilitation, one for subjects in the sub-acute phase post-CVA training 2-3 weeks inpatient and one for outpatients training 2-3 months (2-3x/week). 7) Compare outcomes of experimental (n=16) and control groups (n=8), both undergoing standardized evaluations in the motor, cognitive and quality of life domains. Evaluate pre-/post-inpatient and pre-/post/follow-up -outpatient therapy. Success means better outcomes for experimental group, with an average of 5 points larger increase in Fugl-Mayer assessment, average 6 point more in CAHAI-9, larger increase in executive function, memory, and a 5 point larger reduction in depression. Periodically collect caregiver feedback to determine generalization to independence in real-life activities. NIH

Public Health Relevance

Nationwide annual costs of CVAs are expected to grow to $240 billion by 2030. This project will reduce these costs by improving ADL function, cognition and quality of life through early, intensive intervention post-CVA. Individuals post TBI, cerebral palsy, or post shoulder surgery may also benefit.

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44AG044639-04
Application #
9253164
Study Section
Special Emphasis Panel (ZRG1-MOSS-V (15)B)
Program Officer
St Hillaire-Clarke, Coryse
Project Start
2010-06-30
Project End
2018-05-31
Budget Start
2016-09-30
Budget End
2017-05-31
Support Year
4
Fiscal Year
2016
Total Cost
$567,984
Indirect Cost
Name
Bright Cloud International Corporation
Department
Type
DUNS #
831430389
City
Highland Park
State
NJ
Country
United States
Zip Code
08904
House, G; Burdea, G; Polistico, K et al. (2016) Integrative rehabilitation of residents chronic post-stroke in skilled nursing facilities: the design and evaluation of the BrightArm Duo. Disabil Rehabil Assist Technol 11:683-94
House, Gregory; Burdea, Grigore; Polistico, Kevin et al. (2016) A Rehabilitation First-Tournament Between Teams of Nursing Home Residents with Chronic Stroke. Games Health J 5:75-83
Burdea, Grigore C; Polistico, Kevin; House, Gregory P et al. (2015) Novel integrative virtual rehabilitation reduces symptomatology of primary progressive aphasia - a case report. Int J Neurosci 125:949-58
Burdea, Grigore; Polistico, Kevin; Krishnamoorthy, Amalan et al. (2015) Feasibility study of the BrightBrainer™ integrative cognitive rehabilitation system for elderly with dementia. Disabil Rehabil Assist Technol 10:421-32