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基于脑-肢体协同调控技术探讨rTMS协同改良太极拳对脑卒中后Pusher综合征患者丘脑-皮质功能连接网络的影响

注册号：

Registration number：

ITMCTR2025000072

最近更新日期：

Date of Last Refreshed on：

2025-01-10

注册时间：

Date of Registration：

2025-01-10

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

基于脑-肢体协同调控技术探讨rTMS协同改良太极拳对脑卒中后Pusher综合征患者丘脑-皮质功能连接网络的影响

Public title：

To investigate the effect of rTMS and modified Taijiquan on the functional connection network of thalamic-cortex in patients with Pusher syndrome after stroke based on brain-limb cooperative regulation technique

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于脑-肢体协同调控技术探讨rTMS协同改良太极拳对脑卒中后Pusher综合征患者丘脑-皮质功能连接网络的影响

Scientific title：

To investigate the effect of rTMS and modified Taijiquan on the functional connection network of thalamic-cortex in patients with Pusher syndrome after stroke based on brain-limb cooperative regulation technique

研究课题的正式科学名称简写：

Scientific title acronym：

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

孙婷婷

研究负责人：

孙婷婷

Applicant：

suntingting

Study leader：

suntingting

申请注册联系人电话：

Applicant telephone：

18846925417

研究负责人电话：

Study leader's telephone：

18846925417

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

stt1990action@163.com

研究负责人电子邮件：

Study leader's E-mail：

stt1990action@163.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website
(voluntary supply)：

申请注册联系人通讯地址：

上海市松江区光星路2209号

研究负责人通讯地址：

上海市松江区光星路2209号

Applicant address：

2209 Guangxing Road, Songjiang District, Shanghai

Study leader's address：

2209 Guangxing Road, Songjiang District, Shanghai

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

上海市养志康复医院（上海市阳光康复中心）

Applicant's institution：

Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

养志伦审2024-066

伦理委员会批件附件：

Approved file of Ethical Committee：

查看附件

批准本研究的伦理委员会名称：

上海市养志康复医院（上海市阳光康复中心）医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

伦理委员会批准日期：

Date of approved by ethic committee：

2024/8/13 0:00:00

伦理委员会联系人：

王笑凡

Contact Name of the ethic committee：

wangxiaofan

伦理委员会联系地址：

上海市松江区光星路2209号

Contact Address of the ethic committee：

2209 Guangxing Road, Songjiang District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

021-37730011

伦理委员会联系人邮箱：

Contact email of the ethic committee：

stt1990action@163.com

研究实施负责（组长）单位：

上海市养志康复医院（上海市阳光康复中心）

Primary sponsor：

Medical Ethics Committee of Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

研究实施负责（组长）单位地址：

上海市松江区光星路2209号

Primary sponsor's address：

2209 Guangxing Road, Songjiang District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海市

市(区县)：

Country：

China

Province：

Shanghai Municipality

City：

单位(医院)：

上海市中医药管理局

具体地址：

上海市浦东新区世博村路300号

Institution
hospital：

Shanghai Administration of Traditional Chinese Medicine

Address：

No. 300 Shibocun Road Pudong New Area Shanghai

经费或物资来源：

上海市中医药管理局及上海市养志康复医院（上海市阳光康复中心）

Source(s) of funding：

Shanghai Administration of Traditional Chinese Medicine and Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

研究疾病：

脑卒中倾斜综合征

研究疾病代码：

Target disease：

Post stroke Pusher Syndrome

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

运用现代医学理论及多学科交叉理念，选择一种先进的检测设备，从本质上验证rTMS协同改良太极拳运动对Pusher综合征临床价值。

Objectives of Study：

① Using modern medical theory and interdisciplinary concept selecting an advanced detection equipment essentially verifying the clinical value of rTMS coordinated improvement of Taijiquan in Pusher syndrome.

药物成份或治疗方案详述：

本研究为随机、单盲、对照试验，将招募的72名Pusher综合征患者，考虑脱落率因素，确保最终入组57人；按SPSS25.0生成的随机数表随机分3组，rTMS+常规康复训练组(n=19)和改良太极拳+常规康复训练组(n=19)以及rTMS协同改良太极拳+常规康复训练组(n=19)。 干预方法:三组均给予常规康复治疗方案，包括肢体的主被动关节活动范围训练、体位转移训练、常规平衡功能训练等，1次/d，40min/次，每周6d，连续治疗4周。 rTMS组:患者在常规康复训练的基础上增加低频rTMS，选择武汉依瑞德公司出产的 YRD CCY-IA型经颅磁刺激治疗仪。先测定患者的静息运动阈值（resting motor threshold， RMT）：患者取卧位，全身放松佩并配戴定位帽，采用“8”字型线圈，线圈与颅骨表面相 切，刺激健健大脑运动皮质区（M1区），先给予较大强度单次刺激，后逐渐减少刺激强度，以连续刺激10次至少5次出现运动诱发电位且其幅度超过50μV时的最小输出量，即为该患者的RMT值。应用频率1Hz，输出强度90%RMT，每个序列脉冲持续10s，间歇时间2s，持续20min，1次/d，6d/周，持续治疗4周。 改良太极拳组:从国家体育总局编制的24式简化太极拳中选取“起势、野马分鬃、云手、搂膝拗步、倒卷肱、收势”６式动作供受试者进行康复训练。这６式动作包含从中定步向前、后、左、右四个方向移动的单支撑动作、单肢负重训练、髋膝踝关节位置和动作训练、腰背肌及下肢肌群控制训练、站立和行走平衡训练等多个康复训练科目，除“收势”以外，姿势训练由易至难，循序渐进，适宜中风偏瘫患者进行康复。 rTMS协同改良太极拳组: 协同组患者在常规康复训练的基础上，进行低频rTMS的有效的刺激治疗后，立刻进行改良太极拳运动。rTMS参数与改良太极拳运动方法同前两组。

Description for medicine or protocol of treatment in detail：

This study was a randomized single-blind controlled trial. 72 patients with Pusher syndrome were recruited and 57 patients were eventually enrolled considering the shedding rate.According to the random number table generated by SPSS25.0 they were randomly divided into 3 groups: rTMS+ conventional rehabilitation training group (n=19) improved Tai Chi + conventional rehabilitation training group (n=19) and rTMS co-improved Tai Chi + conventional rehabilitation training group (n=19). Intervention methods: All three groups were given conventional rehabilitation treatment including active and passive joint range of motion training position transfer training conventional balance function training etc. once a day 40 minutes/time 6 days a week for 4 weeks. rTMS group: Patients were added low-frequency rTMS on the basis of routine rehabilitation training and selected YRD CCY-IA transcranial magnetic stimulation therapy instrument produced by Wuhan Ireed Company.The patient's resting motor threshold (RMT) was first measured:The patient was placed in a decine position relaxed and wearing a positioning cap. An "8" shaped coil which was tangent to the skull surface was used to stimulate the motor cortex of the healthy brain (M1 region). A single stimulation of large intensity was given first and then the stimulation intensity was gradually reduced to stimulate the minimum output when the motor evoked potential appeared at least 5 times for 10 consecutive times and its amplitude exceeded 50μV.Is the RMT value of the patient.The application frequency was 1Hz the output intensity was 90%RMT each sequence pulse lasted 10s the interval time was 2s the duration was 20min once a day 6d/ week and the treatment lasted for 4 weeks. Improved Tai Chi group: From the 24 types of simplified Tai Chi prepared by the General Administration of Sport of China six types of movements were selected for the subjects to carry out rehabilitation training: "rising mustang hair splitting cloud hand knee bending step reverse curling and winding".These 6 types of movements include the single support movement in the four directions of forward backward left and right pacing single leg weight training hip knee and ankle position and movement training back and lower limb muscle control training standing and walking balance training and other rehabilitation training subjects in addition to "wind down" postural training from easy to difficult step by step suitable for stroke hemiplegia patients rehabilitation. rTMS coordinated modified Taijiquan group: Patients in the coordinated group received effective stimulation therapy of low-frequency rTMS on the basis of routine rehabilitation training and immediately carried out improved Taijiquan exercise.rTMS parameters and improved tai chi movement methods are the same as the first two groups.

纳入标准：

参照2016年版中华医学会《中国脑血管病诊治指南与共识》中脑卒中相关标准,诊断为脑梗死或脑出血。 ①经CT或MRI证实存在卒中发生的病人； ②确诊为倾斜综合征且Burke倾斜量表(Burkelateropulsionscale,BLS)评分≥2分; ③视力正常,无偏盲; ④简易精神状态检查(mini-mentalstateexamination,MMSE)量表评分≥20分,无明显认知障碍,可理解并配合治疗; ⑤可在辅助下保持站立位或端坐位； ⑥年龄18-75岁。 ⑦在卒中事件后，且病程在3个月-2年之间。

Inclusion criteria

According to the stroke-related criteria in the 2016 edition of Chinese Medical Association's Guidelines and Consensus for the Diagnosis and Treatment of Cerebrovascular Diseases, the diagnosis was cerebral infarction or cerebral hemorrhage. ① Patients with stroke confirmed by CT or MRI; (2) diagnosed with inclined syndrome and Burke tilt scale (Burkelateropulsionscale, BLS) grade 2 or more points; ③ Normal vision, no hemianopsia; (4) simple mental state examination (mini - mentalstateexamination, MMSE) scale score 20 points or more, no significant cognitive impairment, can understand and cooperate with treatment; ⑤ can be maintained in a standing or sitting position with assistance; ⑥ Age 18-75 years old. ⑦ After the stroke event, and the course of disease is between 3 months and 2 years.

排除标准：

①病程中出现新病灶或病情恶化者; ②不能耐受康复训练或依从性差导致训练完成不充分者以及不能配合功能检查； ③严重骨关节功能障碍或其他原因导致不能进行康复训练者； ④重要脏器(心、肝、肾)功能衰竭、自身免疫性疾病、恶性肿瘤等或病情不稳定； ⑤近3个月内有中医运动疗法训练(太极拳、八段锦、五禽戏、六字诀等)； ⑥年龄＜18岁或 ＞75岁，病程＜3个月或＞2年者； ⑦已妊娠患者； ⑧有严重抑郁症状的患者[17项汉密尔顿抑郁量表(HORS)评分24(24)]; ⑨有磁共振检查禁忌证、幽闭恐惧症者。

Exclusion criteria：

① New lesions or deterioration of the disease in the course of the disease; (2) Those who can not tolerate rehabilitation training or poor compliance lead to inadequate training and can not cooperate with functional examination; ③ Serious bone and joint dysfunction or other reasons can not carry out rehabilitation training; ④ Function failure of important organs (heart liver kidney) autoimmune diseases malignant tumors etc. or unstable condition; (5) In the past 3 months traditional Chinese medicine exercise therapy training (Taijiquan eight sections of brocade five poultry six characters etc.); ⑥ Age < 18 years or > 75 years duration of disease < 3 months or > 2 years; ⑦ Pregnant patients; Patients with severe depressive symptoms [17 items Hamilton Depression Scale (HORS) score 24(24)]; ⑨ Patients with contraindications of magnetic resonance examination and claustrophobia.

研究实施时间：

Study execute time：

从From 2024-08-13

至To      2026-04-30

征募观察对象时间：

Recruiting time：

从From 2025-02-28

至To      2026-04-30

干预措施：

Interventions：

组别：

rTMS协同改良太极拳组

样本量：

24

Group：

rTMS collaborative improvement Tai Chi group

Sample size：

干预措施：

rTMS刺激健测大脑运动皮质区，应用频率1Hz；联合24式简化太极拳，选取“起势、野马分鬃、云手、搂膝拗步、倒卷肱、收势”６式动作供受试者进行康复训练。

干预措施代码：

Intervention：

rTMS was used to stimulate and measure the motor cortex of the brain at a frequency of 1Hz.Combined with 24-style simplified Taijiquan the six movements of "rising power mustang hair splitting cloud hand knee bending step reverse brachial curling and winding power" were selected for the subjects to carry out rehabilitation training.

Intervention code：

组别：

改良太极拳组

样本量：

24

Group：

Modified taijiquan group

Sample size：

干预措施：

24式简化太极拳中选取“起势、野马分鬃、云手、搂膝拗步、倒卷肱、收势”６式动作供受试者进行康复训练。

干预措施代码：

Intervention：

In the 24-style simplified Taijiquan the six movements of "rising power mustang hair splitting cloud hand knee bending step reverse brachial curling and closing power" were selected for the subjects to carry out rehabilitation training.

Intervention code：

组别：

rTMS组

样本量：

24

Group：

rTMS Group

Sample size：

干预措施：

rTMS刺激健测大脑运动皮质区，应用频率1Hz；

干预措施代码：

Intervention：

rTMS was used to stimulate and measure the motor cortex of the brain at a frequency of 1Hz.

Intervention code：

样本总量 Total sample size ： 72

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海市

市(区县)：

Country：

China

Province：

Shanghai Municipality

City：

单位(医院)：

上海市养志康复医院（上海市阳光康复中心）

单位级别：

三级康复专科医院

Institution/hospital：

Medical Ethics Committee of Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

Level of the institution：

Tertiary rehabilitation hospital

测量指标：

Outcomes：

指标中文名：

丘脑-皮层功能连接

指标类型：

次要指标

Outcome：

Thalamic cortical functional connectivity

Type：

Secondary indicator

测量时间点：

在患者实验干预前一天和最后一天进行临床疗效评估

测量方法：

量表评估

Measure time point of outcome：

Clinical efficacy was evaluated on the day before and on the last day of the experimental intervention

Measure method：

Scale evaluation

指标中文名：

Burke倾斜量表

指标类型：

主要指标

Outcome：

Burke Lateropulsion Scale

Type：

Primary indicator

测量时间点：

在患者实验干预前一天和最后一天进行临床疗效评估

测量方法：

量表评估

Measure time point of outcome：

Clinical efficacy was evaluated on the day before and on the last day of the experimental intervention

Measure method：

Scale evaluation

指标中文名：

伯格平衡量表

指标类型：

次要指标

Outcome：

Berg balance scale

Type：

Secondary indicator

测量时间点：

在患者实验干预前一天和最后一天进行临床疗效评估

测量方法：

量表评估

Measure time point of outcome：

Clinical efficacy was evaluated on the day before and on the last day of the experimental intervention

Measure method：

Scale evaluation

指标中文名：

改良Barthel指数

指标类型：

次要指标

Outcome：

modified barthel index

Type：

Secondary indicator

测量时间点：

在患者实验干预前一天和最后一天进行临床疗效评估

测量方法：

量表评估

Measure time point of outcome：

Clinical efficacy was evaluated on the day before and on the last day of the experimental intervention

Measure method：

Scale evaluation

指标中文名：

躯干控制测试

指标类型：

次要指标

Outcome：

Trunk control test

Type：

Secondary indicator

测量时间点：

在患者实验干预前一天和最后一天进行临床疗效评估

测量方法：

量表评估

Measure time point of outcome：

Clinical efficacy was evaluated on the day before and on the last day of the experimental intervention

Measure method：

Scale evaluation

指标中文名：

Fugl-Meyer运动功能评分量表

指标类型：

次要指标

Outcome：

Fugl-Meyer assessment scale

Type：

Secondary indicator

测量时间点：

在患者实验干预前一天和最后一天进行临床疗效评估

测量方法：

量表评估

Measure time point of outcome：

Clinical efficacy was evaluated on the day before and on the last day of the experimental intervention

Measure method：

Scale evaluation

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

数据

组织：

Sample Name：

data

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 15 岁
Min age years
最大 75 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

使用简单的分层(计算机生成)随机化协议。随机化是根据住院/门诊情况。主要研究人负责生成整个研究的分配顺序和分配，以及干预措施的分配。随机化发生在参与者的依从性检查之后。受试者将在研究期间由与试验无关的人员随机分组。

Randomization Procedure (please state who generates the random number sequence and by what method)：

A simple hierarchical (computer generated) randomization protocol is used.Randomization was based on inpatient/outpatient situation.The principal investigator is responsible for generating the order and allocation of the entire study, as well as the allocation of interventions.Randomization occurred after participants' compliance checks.Subjects will be randomly assigned to individuals not associated with the trial during the study.

盲法：

双盲试验

Blinding：

double blind clinical trial

是否共享原始数据：

IPD sharing：

否

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

暂无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

not available

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

1）对电子数据采集进行质量控制，在规定的时间窗内采集数据，确保数据准确、真实、可靠、完整。2）对电子数据进行逻辑核查、源数据核查、数据汇总统计分析、质掀检查与评估等原控措施，使临床研究达到要求的数据质量水平。临床试验结束后，需要认真审查总结报告是否属实，包括：结果数据是否科学准确，是否正确分析和评价rTMS协同改良太极拳的临床有效性和安全性；所有质控文件资料是否完整并按规定归档。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

1) Quality control of electronic data collection data collection within the specified time window to ensure that the data is accurate true reliable and complete.2) Logical verification source data verification data summary statistical analysis quality inspection and evaluation of electronic data and other original control measures are carried out to make clinical research reach the required data quality level.After the end of the clinical trial it is necessary to carefully review whether the summary report is true including: whether the result data is scientific and accurate and whether the clinical effectiveness and safety of rTMS collaborative improvement of Taijiquan are correctly analyzed and evaluated;All quality control documents are complete and filed as required.

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

暂无

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

not available

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