Multicenter Randomized Trial of Robot-Assisted Rehabilitation for Chronic Stroke: Methods and Entry Characteristics for VA ROBOTICS
Multicenter Randomized Trial of Robot-Assisted Rehabilitation for Chronic Stroke: Methods and Entry Characteristics for VA ROBOTICS
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DOI：
10.1177/1545968309338195
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发表时间：
2009-10-01
影响因子：
4.2
通讯作者：
Peduzzi, Peter
中科院分区：
文献类型：
--
作者：
Lo, Albert C.;Guarino, Peter;Peduzzi, Peter
背景资料。中风所致的慢性上肢损害具有显著的医疗、心理和经济后果，但很少有研究考察康复治疗在慢性中风期间的有效性。目标。测试MIT-Manus机器人装置治疗中风后慢性上肢功能障碍的安全性和有效性。方法：研究方法。退伍军人管理局合作研究项目于2006年11月启动了一项多中心、随机、对照试验(退伍军人管理局机器人技术)。中风后6个月有上肢损伤的参与者被随机分为机器人辅助治疗(RT)、强化对比治疗(ICT)或常规护理(UC)。RT和ICT包括为期12周的每周三次1小时的治疗。主要结果是12周时Fugl-Meyer上肢运动功能评分相对于基线的变化。次要结果包括Wolf运动功能测试和中风影响量表。结果。共有127名参与者被随机分配：49名接受RT，50名接受ICT，28名接受UC。大多数参与者是男性(96%)，平均年龄为65岁。原发性卒中类型为缺血性(85%)，58%的卒中发生在前循环。20%的参与者报告说，他们除了食指中风外，还有一次中风。从指数卒中到登记的平均时间为56个月(范围为6个月至24年)。Fugl-Meyer的平均得分为18.9分。结论。弗吉尼亚机器人公司证明了进行多中心临床试验的可行性，以便在将新的康复设备引入临床实践之前对其进行严格的测试。预计结果将于2010年初公布。
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 >= 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.