Rémy-Néris Olivier, Le Jeannic Anaïs, Dion Angelina, Médée Béatrice, Nowak Emmanuel, Poiroux Élodie, Durand-Zaleski Isabelle
Physical and Rehabilitation Medicine Department (O.R.-N., B.M., É.P.), Brest University Hospital, France.
University of Brest, France (O.R.-N.).
Stroke. 2021 Jun;52(6):1938-1947. doi: 10.1161/STROKEAHA.120.032545. Epub 2021 Apr 29.
Additional therapy may improve poststroke outcomes. Self-rehabilitation is a useful means to increase rehabilitation time. Mechanized systems are usual means to extend time for motor training. The primary aim was to compare the effects of self-rehabilitation using a mechanized device with control self-exercises on upper extremity impairment in patients with stroke.
Phase III, parallel, concealed allocation, randomized controlled, multicenter trial, with 12-month follow-up. Patients aged 18 to 80 years, 3 weeks to 3 months poststroke with a Fugl-Meyer Assessment score of 10 to 40 points, were randomized to the Exo or control groups. All undertook two 30-minute self-rehabilitation sessions/day, 5 days/wk for 4 weeks in addition to usual rehabilitation. The Exo group performed games-based exercises using a gravity-supported mechanical exoskeleton (Armeo Spring). The control group performed stretching plus basic active exercises. Primary outcome was change in upper extremity Fugl-Meyer Assessment score at 4 weeks.
Two hundred fifteen participants were randomly allocated to the Exo group (107) or the control group (108). Mean age (SD), 58.3 (13.6) years; mean time poststroke, 54.8 (22.1) days; and mean baseline Fugl-Meyer Assessment score, 26.1 (9.5). There was no between-group difference in mean change in Fugl-Meyer Assessment score following the intervention: 13.3 (9.0) in the Exo group and 11.8 (8.8) in the control group (P=0.22). There were no significant between-group differences in changes for any of the other outcomes at any time point (except for perception of the self-rehabilitation). There was no between-group difference in cost utility at 12 months.
In patients with moderate-to-severe impairment in the subacute phase of stroke, the purchase and use of complex devices to provide additional upper limb training may not be necessary: simply educating patients to regularly move and stretch their limbs appears sufficient.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT01383512.
额外的治疗可能会改善中风后的预后。自我康复是增加康复时间的一种有效方式。机械系统是延长运动训练时间的常用手段。主要目的是比较使用机械装置进行自我康复与对照自我训练对中风患者上肢功能障碍的影响。
III期、平行、隐蔽分配、随机对照、多中心试验，随访12个月。年龄在18至80岁之间、中风后3周至3个月且Fugl-Meyer评估评分在10至40分之间的患者被随机分为外骨骼组或对照组。除常规康复治疗外，所有患者均每天进行两次30分钟的自我康复训练，每周5天，共4周。外骨骼组使用重力支持的机械外骨骼（Armeo Spring）进行基于游戏的训练。对照组进行拉伸加基本主动训练。主要结局是4周时上肢Fugl-Meyer评估评分的变化。
215名参与者被随机分配到外骨骼组（107名）或对照组（108名）。平均年龄（标准差）为58.3（13.6）岁；中风后平均时间为54.8（22.1）天；平均基线Fugl-Meyer评估评分为26.1（9.5）。干预后Fugl-Meyer评估评分的平均变化在两组之间无差异：外骨骼组为13.3（9.0），对照组为11.8（8.8）（P = 0.22）。在任何时间点，任何其他结局的变化在两组之间均无显著差异（自我康复的感知除外）。12个月时成本效用在两组之间无差异。
对于中风亚急性期有中度至重度功能障碍的患者，购买和使用复杂设备来提供额外的上肢训练可能没有必要：简单地教育患者定期活动和伸展四肢似乎就足够了。
