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健侧下肢针刺联合康复治疗对缺血性脑卒中后手运动功能障碍的随机对照 Pilot 研究方案。

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.

机构信息

Department of Acupuncture, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300193, China.

Department of Acupuncture, Zhejiang Chinese Medical University Affiliated Third Hospital, Hangzhou 310012, China.

出版信息

J Tradit Chin Med. 2023 Oct;43(5):1034-1039. doi: 10.19852/j.cnki.jtcm.2023.05.007.

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.

摘要

本研究旨在评估康复治疗联合健侧足部针刺(在非瘫痪侧足部进行针刺操作)对脑卒中后瘫痪手恢复的即时疗效。该前瞻性临床研究将纳入 72 例病程 14-90d 的脑卒中后偏瘫手患者。将患者随机分为两组:对照组接受醒脑开窍针刺和常规脑卒中基础治疗;观察组在对照组基础上增加健侧足部针刺联合患侧手康复运动。两组患者均连续治疗 2 周,共 12 次。主要结局指标为 Fugl-Meyer 上肢运动功能评定,次要结局指标包括手握力、关节活动度、改良 Barthel 指数和 Brunnstrom 恢复阶段。通过比较两组患者在 2 周治疗期间手部运动功能的恢复情况,探讨健侧足部针刺联合康复运动对脑卒中后运动功能障碍偏瘫手的即时疗效,为后续大样本研究提供前期依据。

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