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Multicenter Randomized Trial of Robot-Assisted Rehabilitation for Chronic Stroke: Methods and Entry Characteristics for VA ROBOTICSProvidence VA Medical Center, Brown University, VA RR&D Center of Excellence-Center for Restorative and Regenerative Medicine, Providence, Rhode Island, Albert.Lo{at}va.gov
VA Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System, West Haven, Connecticut
Massachusetts Institute of Technology, Cambridge, Massachusetts
Burke Institute of Medical Research, Weill Medical College, Cornell University, White Plains, New York
VA Maryland Healthcare System, and the Department of Neurology, University of Maryland School of Medicine, Baltimore, Maryland
Duke Center for Clinical Health Policy Research, Duke University, Durham, North Carolina
VA Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center, Albuquerque, New Mexico
Health Economics Resource Center, VA Palo Alto Healthcare System, Menlo Park, California
North Florida/South Georgia Veterans Health System, and the University of Florida, Gainesville, Florida
Richard L. Roudebush VAMC, Indianapolis, Indiana
VA Puget Sound Healthcare System, and the University of Washington, Seattle, Washington
Veterans Affairs Medical Center Baltimore Geriatrics Research, Education and Clinical Center, and the Department of Neurology, University of Maryland School of Medicine, Baltimore, Maryland
VA Connecticut Healthcare System, West Haven, and Yale University, New Haven, Connecticut
VA Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System, West Haven, Connecticut
Providence VA Medical Center, Brown University, VA RR&D Center of Excellence-Center for Restorative and Regenerative Medicine, Providence, Rhode Island
Providence VA Medical Center, Brown University, VA RR&D Center of Excellence-Center for Restorative and Regenerative Medicine, Providence, Rhode Island
Background. Chronic upper extremity impairment due to stroke has significant medical, psychosocial, and financial consequences, but few studies have examined the effectiveness of rehabilitation therapy during the chronic stroke period. Objective. To test the safety and efficacy of the MIT-Manus robotic device for chronic upper extremity impairment following stroke. Methods. The VA Cooperative Studies Program initiated a multicenter, randomized, controlled trial in November 2006 (VA ROBOTICS). Participants with upper extremity impairment
Key Words: Stroke • Rehabilitation • Robotics • Randomized clinical trial • Health economics
This version was published on October
1, 2009 Neurorehabilitation and Neural Repair, Vol. 23, No. 8,
775-783 (2009) |
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6 months poststroke were randomized to robot-assisted therapy (RT), intensive comparison therapy (ICT), or usual care (UC). RT and ICT consisted of three 1-hour treatment sessions per week for 12 weeks. The primary outcome was change in the Fugl-Meyer Assessment upper extremity motor function score at 12 weeks relative to baseline. Secondary outcomes included the Wolf Motor Function Test and the Stroke Impact Scale. Results. A total of 127 participants were randomized: 49 to RT, 50 to ICT, and 28 to UC. The majority of participants were male (96%), with a mean age of 65 years. The primary stroke type was ischemic (85%), and 58% of strokes occurred in the anterior circulation. Twenty percent of the participants reported a stroke in addition to their index stroke. The average time from the index stroke to enrollment was 56 months (range, 6 months to 24 years). The mean Fugl-Meyer score at entry was 18.9. Conclusions. VA ROBOTICS demonstrates the feasibility of conducting multicenter clinical trials to rigorously test new rehabilitative devices before their introduction to clinical practice. The results are expected in early 2010.