Rehabilitation Medicine Center, Sichuan University West China Hospital, Chengdu, Sichuan, China.
Key Laboratory of Rehabilitation Medicine in Sichuan Province, Sichuan University West China Hospital, Chengdu, Sichuan, China.
BMJ Open. 2022 Aug 10;12(8):e064905. doi: 10.1136/bmjopen-2022-064905.
Poststroke pusher syndrome (PS) prevalence is high. Patients with PS require longer rehabilitation with prolonged length of stay. Effective treatment of PS remains a challenge for rehabilitation professionals. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that is effective and recommended in the clinical guidelines of stroke rehabilitation. However, the role of rTMS for PS has not been examined. The study is to assess the efficacy of a specific rTMS programme for patients with PS in reducing pushing behaviour, enhancing motor recovery and improving mobility, as well as testing the safety of rTMS for patients with PS.
A randomised, patient and assessor blinded sham-controlled trial with two parallel groups will be conducted. Thirty-four eligible patients with PS will be randomly allocated to receive either rTMS or sham rTMS for 3 weeks. The primary assessment outcome is the pushing behaviour measured by the Burke Lateropulsion Scale and Scale for Contraversive Pushing. The secondary outcomes are the motor functions and mobility measured by the Fugl-Meyer Assessment Scale (motor domain) and Modified Rivermead Mobility Index, and any adverse events. Assessment will be performed at baseline and 1 week, 2 weeks and 3 weeks after intervention. Repeated-measures analysis of variance will be used for data analysis with the level of significance level set at 0.05.
The protocol has been approved by the Biomedical Ethics Committee of West China Hospital, Sichuan University on 23 March 2022 (2022-133). The trial findings will be published in peer-reviewed journals.
Chinese Clinical Trial Registry (ChiCTR2200058015).
脑卒中后推挤综合征(PS)的患病率较高。PS 患者需要更长时间的康复治疗,住院时间也更长。对于康复专业人员来说,有效治疗 PS 仍然是一个挑战。重复经颅磁刺激(rTMS)是一种非侵入性的神经调节技术,在脑卒中康复的临床指南中被证明是有效且推荐使用的。然而,rTMS 治疗 PS 的作用尚未得到检验。本研究旨在评估针对 PS 患者的特定 rTMS 方案在减少推挤行为、促进运动功能恢复和提高活动能力方面的疗效,并检验 rTMS 治疗 PS 患者的安全性。
将进行一项随机、患者和评估者双盲假对照试验,有两个平行组。将 34 名符合条件的 PS 患者随机分配接受 rTMS 或假 rTMS 治疗 3 周。主要评估结果是通过 Burke 侧推量表和对侧推挤量表测量的推挤行为。次要结局是通过 Fugl-Meyer 评估量表(运动域)和改良 Rivermead 移动指数测量的运动功能和活动能力,以及任何不良事件。评估将在基线以及干预后 1 周、2 周和 3 周进行。将使用重复测量方差分析进行数据分析,显著性水平设为 0.05。
该方案已于 2022 年 3 月 23 日获得四川大学华西医院生物医学伦理委员会的批准(2022-133)。试验结果将发表在同行评议的期刊上。
中国临床试验注册中心(ChiCTR2200058015)。