Three-dimensional, task-specific robot therapy of the arm after stroke: a multicentre, parallel-group randomised trial
Three-dimensional, task-specific robot therapy of the arm after stroke: a multicentre, parallel-group randomised trial
复制标题
DOI：
10.1016/s1474-4422(13)70305-3
复制
发表时间：
2014-02-01
期刊：
影响因子：
48
通讯作者：
Riener, Robert
中科院分区：
文献类型：
--
作者：
Klamroth-Marganska, Verena;Blanco, Javier;Riener, Robert
中风继发的背景是常见的和残疾。我们的目的是评估Armin对受影响的手臂的机器人训练是否与常规治疗相比，在三维中允许特定于任务的训练可以更有效地减少运动障碍。患有运动障碍超过6个月的患者以及脑血管事故发生后中度至重度的患者瑞士四个中心的资格标准。将合格的患者随机分配（1：1），以使用中层分层的随机化程序接受机器人或常规治疗。对于这两组，每周至少3次接受治疗，持续8周（总共24个课程）。主要结果是FUGL-MEYER评估（FMA-EU）的ARM（上肢）部分的分数变化。评估人员在治疗4周后，在治疗结束后以及治疗开始后的16周和34周对患者进行了测试。评估人员被掩盖到治疗分配中，但是患者，治疗师和数据分析师被揭露了。分析是通过修改意图来治疗的。这项研究已在Clinicaltrials.gov中注册，数字NCT00719433。在2009年5月4日至2012年9月3日之间进行调查，对143个人的资格进行了测试，其中77名符合条件并同意参加。分析中包括38例分配给机器人疗法的患者，并分配给常规疗法的35名患者。通过通过FMA-E的衡量，分配给机器人疗法的患者在研究过程中的运动功能的改善要比分配给常规治疗的患者更大（F = 4.1，P = 0 041；得分平均差异0.788；点，95％CI 0.03-1.53）。没有与研究相关的严重不良事件。解释神经治疗疗法，包括用外骨骼机器人进行任务训练，可以在中风后长期受损的paretic手臂中的运动功能改善比传统疗法更有效地改善运动功能。但是，在我们的研究中，机器人和常规疗法的影响之间的绝对差异很小且意义较弱，这使有关临床相关性。
Background Ann hemiparesis secondary to stroke is common and disabling. We aimed to assess whether robotic training of an affected arm with ARMin an exoskeleton robot that allows task-specific training in three dimensions reduces motor impairment more effectively than does conventional therapy.Methods In a prospective, multicentre, parallel-group randomised trial, we enrolled patients who had had motor impairment for more than 6 months and moderate-to-severe arm paresis after a cerebrovascular accident who met our eligibility criteria from four centres in Switzerland. Eligible patients were randomly assigned (1:1) to receive robotic or conventional therapy using a centre-stratified randomisation procedure. For both groups, therapy was given for at least 45 mm three times a week for 8 weeks (total 24 sessions). The primary outcome was change in score on the arm (upper extremity) section of the Fugl-Meyer assessment (FMA-UE). Assessors tested patients immediately before therapy, after 4 weeks of therapy, at the end of therapy, and 16 weeks and 34 weeks after start of therapy. Assessors were masked to treatment allocation, but patients, therapists, and data analysts were unmasked. Analyses were by modified intention to treat. This study is registered with ClinicalTrials.gov, number NCT00719433.Findings Between May 4, 2009, and Sept 3, 2012, 143 individuals were tested for eligibility, of whom 77 were eligible and agreed to participate. 38 patients assigned to robotic therapy and 35 assigned to conventional therapy were included in analyses. Patients assigned to robotic therapy had significantly greater improvements in motor function in the affected arm over the course of the study as measured by FMA-UE than did those assigned to conventional therapy (F=4.1, p=0 041; mean difference in score 0.78 points, 95% CI 0.03-1.53). No serious adverse events related to the study occurred.Interpretation Neurorehabilitation therapy including task-oriented training with an exoskeleton robot can enhance improvement of motor function in a chronically impaired paretic arm after stroke more effectively than conventional therapy. However, the absolute difference between effects of robotic and conventional therapy in our study was small and of weak significance, which leaves the clinical relevance in question.