Contralateral needling at the foot of unaffected side combining with rehabilitation treatment for motor dysfunction of hand after ischemic stroke: study protocol for a randomized controlled pilot trial.

L I Menghan, Yan Yan, Deng Shizhe, Wang Yu, F U Yu, Shi Lei, Yang Jin, Zhang Chunhong
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Abstract

This pilot study is to assess the feasibility and the effect of a combination therapy of rehabilitation treatment and contralateral needling, which is manipulated at the foot of the unaffected side, for the recovery of the paretic hand post-stroke. This prospective pilot clinical trial will recruit 72 stroke patients with paretic hands and a disease course of 14 to 90 d. Patients will be randomized into two groups: the control group will receive conventional Xingnao Kaiqiao acupuncture and basic treatment for the stroke; based on the control group, the observation group will receive the contralateral needling at the foot of the unaffected side combined with the rehabilitation movement of the paretic hand. 12 sessions will be administrated for 2 weeks. The primary outcome, Fugl-Meyer Assessment, and the secondary outcomes, the handgrip strength, the range of motion, the modified Barthel index, and the Brunnstrom recovery stages, will be measured the recovery of the hand motor function during the 2 weeks' intervention. This study aims to investigate the instant effect of contralateral needling at the foot of the unaffected side combined with the rehabilitation treatment movement for patients with the paretic hand of Poststroke motor dysfunction and provide the previous evidence for the future large sample studies.

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未受影响侧足部对侧针刺结合康复治疗缺血性脑卒中后手部运动功能障碍:一项随机对照试点试验的研究方案。
这项初步研究旨在评估康复治疗和对侧针刺(在未受影响一侧的足部进行操作)相结合的疗法对中风后偏瘫手部康复的可行性和效果。这项前瞻性试点临床试验将招募72名手部偏瘫、病程14至90天的中风患者。患者将被随机分为两组:对照组接受常规醒脑开窍针灸和中风基础治疗;观察组在对照组的基础上,对侧针刺未患侧足,结合偏瘫手的康复运动。12个疗程,为期2周。主要结果(Fugl-Meyer评估)和次要结果(握力、运动范围、改良Barthel指数和Brunnstrom恢复阶段)将通过2周干预期间手部运动功能的恢复进行测量。本研究旨在探讨对侧针刺未受影响侧足结合康复治疗运动对脑卒中后偏瘫手运动功能障碍患者的即时效果,为未来的大样本研究提供前期证据。
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