Zhou Jie, Fan Lijuan, Hu Hantong, Shen Ke, Wu Liya, Lin Xiaoqi, Gao Hong
Department of Acupuncture and Moxibustion, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, People's Republic of China.
The Third Clinical College of Zhejiang Chinese Medical University, Hangzhou, People's Republic of China.
Int J Gen Med. 2022 Sep 6;15:7101-7111. doi: 10.2147/IJGM.S381434. eCollection 2022.
Post-stroke anxiety (PSA) remains a challenging medical problem. Integrated rehabilitation involves a combination of traditional Chinese medicine (TCM) and Western conventional rehabilitation techniques. Theoretically, integrated rehabilitation is likely to have significant advantages in treating PSA. Nevertheless, the therapeutic effect of integrated rehabilitation needs to be verified based on large-scale trials with sound methodology. Thus, the aim of this trial is to assess the efficacy and safety of integrated rehabilitation on PSA.
The study is a prospective, multicenter, randomized, controlled trial involving 188 PSA patients from four clinical centers in China. Eligible participants will be randomly divided into the integrated rehabilitation group or the standard care group. Participants in the integrated rehabilitation group will receive a combination of TCM and Western conventional rehabilitation methods, including acupuncture, repeated transcranial magnetic stimulation, traditional Chinese herbal medicine, and standard care. The primary outcome will be the Hamilton Anxiety Rating Scale (HAM-A). The secondary outcomes will include the Self-Rating Anxiety Scale (SAS), the Activities of Daily Living (ADL) scale, the Montreal Cognitive Assessment (MoCA) scale, the simplified Fugl-Meyer Assessment of motor function (FMA) scale, and the Pittsburgh Sleep Quality Index (PSQI). Outcome measurements will be performed at baseline, at the end of the 4-week treatment and the 8-week follow-up.
Results of this trial will ascertain the efficacy and safety of integrated rehabilitation on PSA, thereby providing evidence regarding integrated rehabilitation strategies for treating PSA. It will also promote up-to-date evidence for patients, clinicians, and policy-makers.
ClinicalTrials.gov NCT05147077.
中风后焦虑（PSA）仍然是一个具有挑战性的医学问题。综合康复包括将中医（TCM）与西方传统康复技术相结合。从理论上讲，综合康复在治疗PSA方面可能具有显著优势。然而，综合康复的治疗效果需要基于方法合理的大规模试验来验证。因此，本试验的目的是评估综合康复治疗PSA的疗效和安全性。
本研究是一项前瞻性、多中心、随机对照试验，纳入了来自中国四个临床中心的188例PSA患者。符合条件的参与者将被随机分为综合康复组或标准护理组。综合康复组的参与者将接受中医和西方传统康复方法的联合治疗，包括针灸、重复经颅磁刺激、中药和标准护理。主要结局指标将是汉密尔顿焦虑量表（HAM-A）。次要结局指标将包括自评焦虑量表（SAS）、日常生活活动（ADL）量表、蒙特利尔认知评估（MoCA）量表、简化Fugl-Meyer运动功能评估（FMA）量表和匹兹堡睡眠质量指数（PSQI）。结局测量将在基线、4周治疗结束时和8周随访时进行。
本试验的结果将确定综合康复治疗PSA的疗效和安全性，从而为治疗PSA的综合康复策略提供证据。它还将为患者、临床医生和政策制定者提供最新的证据。
ClinicalTrials.gov NCT05147077。
