Development of BATRAC Training Device in Subacute Stroke Population

DESCRIPTION (provided by applicant): Approximately 800,000 people suffer a stroke every year and well over half are left with significant residual disability involving arm dysfunction. Effective strategies are needed to reduce the long-term disability and functional impairment from upper extremity paralysis. Newregen was formed in 2006 to commercialize a clinically proven arm training device for stroke, known as BATRAC. Previous studies have shown that BATRAC training improves arm motor function in mild and moderately affected patients with chronic hemiparesis. In its original design the device was used for training purposes only with no instrumentation that would permit collection of patient performance data and limited methods of providing feedback to users and physical therapists. BATRAC has not yet been tested in the subacute stage of stroke, during which most recovery takes place (immediate post acute hospitalization) and when the potential for functional recovery may be greater. In the proposed work Newregen aims to: 1) develop the BATRAC training device to include instrumentation that permits the collection of patient performance data during use of the device and that provides feedback to patients regarding performance and progress during training. The instrumentation will track the progress of multiple patients who use the same unit. 2) determine the advantage of BATRAC training over the current standard of care, and demonstrate the feasibility of use of the BATRAC training device and tolerance to the progressive training protocol in the inpatient and outpatient subacute care population post-stroke. A single group design will be used to test the feasibility of training with the BATRAC device and tolerance to the protocol in a cohort of 10 patients following ischemic or hemorrhagic stroke in the subacute setting. Results will be measured using two motor function tests, a stroke disability measurement, and a disability scale, and compared to a cohort of 5 patients who received standard treatment. Evidence of the effectiveness and feasibility of using the device on the subacute stroke population compared to standard care will demonstrate the marketability of the device to hospital-based rehabilitation centers that treat multiple patients at the subacute stage. If the effectiveness of BATRAC is demonstrated in the Phase 1 effort, Newregen will submit a Phase II application with the following objectives: 1) produce 12 electronic instrumentation device prototypes for distribution to stroke rehabilitation centers for Beta testing; 2) compare the use of BATRAC training to the current standard of care practice in a full randomized controlled trial; and 3) evaluate the inclusion of BATRAC in combination therapies in upper extremity rehabilitation. PUBLIC HEALTH RELEVANCE. 800,000 Americans have a stroke every year. Over 5 1/2 million Americans are living with the effects of stroke. This research will result in the creation of a cost-effective, easy to use device that will restore arm function in stroke survivors who experience paralysis. The device: 1) Will have been proven effective in clinical studies, both for chronic and subacute stroke 2) Will be used by patients in their own homes or in a rehabilitation center, as they choose 3) Does not require a prescription 4) Will be the most cost-effective solution on the market for this condition 5) Will restore a significant quality of life for thousands stroke patients