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Synergistic effect of acupuncture and mirror therapy on post-stroke upper limb dysfunction: a study protocol for a randomized controlled trial

机译：针刺和镜像疗法对中风后上肢功能障碍的协同作用：一项随机对照试验的研究方案

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Upper limb dysfunction is common after stroke, posing an important challenge for post-stroke rehabilitation. The clinical efficacy of acupuncture for the recovery of post-stroke upper limb function has been previously demonstrated. Mirror therapy (MT) has also been found to be effective. However, the effects of acupuncture and MT have not been systematically compared. This trial aims to elucidate the synergistic effects of acupuncture and MT on upper limb dysfunction after stroke. A 2 × 2 factorial randomized controlled trial will be conducted at the rehabilitation hospitals affiliated with Fujian University of Traditional Chinese Medicine. A total of 136 eligible subjects will be randomly divided into acupuncture treatment (AT), MT, combined treatment, and control groups in a 1:1:1:1 ratio. All subjects will receive conventional treatment. The interventions will be performed 5 days per week for 4 weeks. AT, MT, and combined treatment will be performed for 30 min per day (combined treatment: AT 15 min + MT 15 min). The primary outcomes in this study will be the mean change in scores on both the FMA and WMFT from baseline to 4 weeks intervention and at 12 weeks follow-up between the two groups and within groups. The secondary outcomes are the mean change in the scores on the Visual Analogue Scale, Stroke Impact Scale, and modified Barthel index. Medical abstraction of adverse events will be assessed at each visit. The results of this trial will demonstrate the synergistic effect of acupuncture and MT on upper limb motor dysfunction after stroke. In addition, whether AT and MT, either combined or alone, are more effective than the conventional treatment in the management of post-stroke upper limb dysfunction will also be determined. Chinese Clinical Trial Registry: ChiCTR-IOR-17011118 . Registered on April 11, 2017. Version number: 01.2016.09.1.
机译：中风后上肢功能障碍很常见，对中风后康复提出了重要挑战。先前已证明针灸可恢复中风后上肢功能的临床疗效。镜疗法（MT）也被发现是有效的。但是，针灸和MT的效果尚未系统地进行比较。该试验旨在阐明针刺和MT对中风后上肢功能障碍的协同作用。将在福建中医药大学附属康复医院进行2×2析因随机对照试验。总共136名符合条件的受试者将以1：1：1：1的比例随机分为针灸治疗（AT），MT，联合治疗和对照组。所有受试者将接受常规治疗。干预将每周执行5天，持续4周。每天进行30分钟的AT，MT和联合治疗（联合治疗：AT 15分钟+ MT 15分钟）。这项研究的主要结果将是FMA和WMFT的评分从基线干预到4周以及两组之间以及组内12周随访时的平均变化。次要结果是视觉模拟量表，中风影响量表和修正的Barthel指数得分的平均变化。每次访视时都会评估不良事件的医学摘要。该试验的结果将证明针刺和MT对中风后上肢运动功能障碍的协同作用。此外，还应确定AT和MT联合使用还是单独使用，比常规治疗在卒中后上肢功能障碍的治疗中更有效。中国临床试验注册中心：ChiCTR-IOR-17011118。 2017年4月11日注册。版本号：01.2016.09.1。

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