Author: Qiurong Xie1,2, Jinsong Wu1,2, Qi Zhang1,2, Yanxin Zhang3, Bo Sheng4, Xiaoling Wang1,2, Jia Huang5,6
Affiliation: <sup>1</sup> Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China.
<sup>2</sup> Key Laboratory of Orthopedics & Traumatology of Traditional Chinese Medicine and Rehabilitation (Fujian University of TCM), Ministry of Education, Fuzhou, 350122, China.
<sup>3</sup> The University of Auckland, Auckland, New Zealand, 1142.
<sup>4</sup> Shanghai University, Shanghai, 200444, China.
<sup>5</sup> Fujian University of Traditional Chinese Medicine, Fuzhou, 350122, China. jasmine1874@163.com.
<sup>6</sup> Key Laboratory of Orthopedics & Traumatology of Traditional Chinese Medicine and Rehabilitation (Fujian University of TCM), Ministry of Education, Fuzhou, 350122, China. jasmine1874@163.com.
Conference/Journal: Trials
Date published: 2023 Dec 4
Other:
Volume ID: 24 , Issue ID: 1 , Pages: 788 , Special Notes: doi: 10.1186/s13063-023-07743-w. , Word Count: 319
Background:
Upper limb dysfunction seriously affects the ability of stroke patients to perform activities of daily living. As a popular exercise therapy, Tai Chi may become an alternative intervention. However, the neurophysiological mechanism by which Tai Chi improves upper limb dysfunction in stroke patients is still unclear, which limits its further promotion and application. Therefore, conducting a strict randomized clinical trial is necessary to observe how Tai Chi affects upper limb dysfunction in stroke patients and to explore its neurophysiological mechanism.
Methods/design:
This report describes a randomized, parallel-controlled trial with distributive concealment and evaluator blinding. A total of 84 eligible participants will be randomly assigned to the Tai Chi group or the control group in a 1:1 ratio. The participants in the Tai Chi group will receive 4 weeks of Tai Chi training: five 60-min sessions a week for a total of 20 sessions. The participants in the control group will not receive Tai Chi training. Both groups will receive medical treatment and routine rehabilitation training. The primary outcome measure is the mean change in the Fugl-Meyer Assessment Upper Extremity (FMA-UE) scale score between baseline and 4 weeks; the secondary outcomes are the mean changes in kinematic characteristics and the Wolf Motor Function Test (WMFT) and Stroke Impact Scale (SIS) scores. In addition, the corticomuscular coupling level and near-infrared brain functional imaging will be monitored to explore the mechanism by which Tai Chi improves upper limb function of stroke patients.
Discussion:
This randomized controlled trial will examine the effectiveness of Tai Chi in stroke patients with upper limb dysfunction and explore the neurophysiological mechanism. Positive results will verify that Tai Chi can improve upper limb function of stroke patients.
Trial registration:
Chinese Clinical Trial Registration Center, ChiCTR2200061376 (retrospectively registered). Registered June 22, 2022. http://www.chictr.org.cn/listbycreater.aspx . Manuscript Version: 3.0 Manuscript Date: October 10, 2023.
Keywords: Brain imaging; Corticomuscular coupling; Randomized controlled trial; Stroke; Tai Chi; Upper limb function.
PMID: 38049898 DOI: 10.1186/s13063-023-07743-w