Wei-Hao Fang1, Gui-Ling Wang2, Qiang Liu3, Xiao Ding1, Zhen-Yao Wang1, Xin-Wei Wang1, Xiao-Wei Yang1, Yang Yang1, Da-Wei Zhang1, Qing Wei1, Hu Zhang4. 1. Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital, Beijing, 101300, China. 2. Beijing Hospital of Traditional Chinese Medicine, Beijing, 100010, China. 3. World Federation of Chinese Medicine Societies, Beijing, 100101, China. 4. Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital, Beijing, 101300, China. zhanghu0709@sohu.com.
Abstract
BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: Chictr.org.cn ChiCTR1900021774 . Registered on 8 March 2019.
RCT Entities:
BACKGROUND: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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: Chictr.org.cn ChiCTR1900021774 . Registered on 8 March 2019.
Entities:
Keywords:
Acupuncture; Hemiplegia; Ischaemic stroke; Randomised controlled trial; Study protocol
Authors: J Du; L Tian; W Liu; J Hu; G Xu; M Ma; X Fan; R Ye; Y Jiang; Q Yin; W Zhu; Y Xiong; F Yang; X Liu Journal: Eur J Neurol Date: 2016-07-18 Impact factor: 6.089