Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital, Beijing, 101300, China.
Beijing Hospital of Traditional Chinese Medicine, Beijing, 100010, China.
Trials. 2021 Mar 18;22(1):215. doi: 10.1186/s13063-021-05128-5.
Hemiplegia is a common sequela after stroke, and acupuncture is one of the most common physical therapies used to treat hemiplegia during the recovery stage after ischaemic stroke. 'Hand and foot acupuncture with twelve needles' is an acupuncture treatment performed after stroke. The principal objective of this study is to assess the efficacy and safety of 'hand and foot acupuncture with twelve needles' for hemiplegia in the convalescent stage of ischaemic stroke.
This is the protocol for a randomised, controlled clinical trial with two groups: a 'hand and foot acupuncture with twelve needles' group and a routine acupuncture group. A total of 208 participants will be randomly assigned to two different groups in a 1:1 ratio and will undergo conventional rehabilitation. Limb function will be evaluated by the simplified Fugl-Meyer assessment scale, Barthel Index, modified Ashworth scale and National Institute of Health stroke scale. The participants will be evaluated at baseline (on the day of enrolment) and followed up at 2 weeks, 1 month, 2 months and 3 months after enrolment.
The results of this study will provide evidence on the effectiveness of 'hand and foot acupuncture with twelve needles' in the treatment of limb dysfunction that can be used for future evaluations.
Chictr.org.cn ChiCTR1900021774 . Registered on 8 March 2019.
偏瘫是中风后的常见后遗症，针灸是治疗缺血性中风后恢复期偏瘫最常用的物理疗法之一。“手足十二针”是中风后进行的一种针灸治疗。本研究的主要目的是评估“手足十二针”治疗缺血性中风恢复期偏瘫的疗效和安全性。
这是一项随机对照临床试验的方案，分为两组：“手足十二针”组和常规针刺组。将 208 名参与者以 1:1 的比例随机分配到两个不同的组，并接受常规康复治疗。肢体功能将通过简化 Fugl-Meyer 评估量表、Barthel 指数、改良 Ashworth 量表和国立卫生研究院中风量表进行评估。参与者将在基线（入组当天）进行评估，并在入组后 2 周、1 个月、2 个月和 3 个月进行随访。
本研究的结果将为“手足十二针”治疗肢体功能障碍的有效性提供证据，可用于未来的评估。
Chictr.org.cn ChiCTR1900021774。于 2019 年 3 月 8 日注册。
