ChiCTR2500113935 版本V1.0 版本创建时间2025/12/04 16:10:32 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500113935 

最近更新日期：

Date of Last Refreshed on：

 2025-12-04 16:10:13 

注册时间：

Date of Registration：

 2025-12-04 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

经颅磁刺激联合运动想象疗法对脑卒中患者下肢运动功能和平衡功能的影响

Public title：

The influence of transcranial magnetic stimulation combined with motor imagery therapy on lower limb motor function and balance function in stroke patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

经颅磁刺激联合运动想象疗法对脑卒中患者下肢运动功能和平衡功能的影响

Scientific title：

The influence of transcranial magnetic stimulation combined with motor imagery therapy on lower limb motor function and balance function in stroke patients

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：

张海娜 

研究负责人：

张海娜 

Applicant：

Zhang Haina 

Study leader：

Zhang Haina 

申请注册联系人电话：

Applicant telephone：

 +86 150 9039 6209

研究负责人电话：

Study leader's
telephone：

+86 150 9039 6209

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：

 hnxxzhn@126.com

研究负责人电子邮件：

Study leader's E-mail：

 hnxxzhn@126.com

申请单位网址(自愿提供)：

Applicant 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：

中国河南省新乡市卫辉市健康路88号

研究负责人通讯地址：

中国河南省新乡市卫辉市健康路88号

Applicant address：

No. 88, Health Road, Weihui City, Xinxiang, Henan, China

Study leader's address：

No. 88, Health Road, Weihui City, Xinxiang, Henan, China

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：

新乡医学院第一附属医院

Applicant's institution：

The First Affiliated Hospital of Xinxiang Medical University

研究负责人所在单位：

新乡医学院第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Xinxiang Medical University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 EC-023-638

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

新乡医学院第一附属医院伦理委员会

Name of the ethic committee：

The Ethics Committee of the First Affiliated Hospital of Xinxiang Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-05-25 00:00:00

伦理委员会联系人：

郭鑫鑫

Contact Name of the ethic committee：

Guo Xinxin

伦理委员会联系地址：

中国河南省新乡市卫辉市健康路88号

Contact Address of the ethic committee：

No. 88, Health Road, Weihui City, Xinxiang, Henan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 150 9033 0530

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

新乡医学院第一附属医院

Primary sponsor：

The First Affiliated Hospital of Xinxiang Medical University

研究实施负责（组长）单位地址：

中国河南省新乡市卫辉市健康路88号

Primary sponsor's address：

No. 88, Health Road, Weihui City, Xinxiang, Henan, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

新乡

市(区县)：

新乡

Country：

CHINA

Province：

Henan

City：

Xinxiang

单位(医院)：

新乡医学院第一附属医院

具体地址：

中国河南省新乡市卫辉市健康路88号

Institution
hospital：

The First Affiliated Hospital of Xinxiang Medical University

Address：

No. 88, Health Road, Weihui City, Xinxiang, Henan, China

经费或物资来源：

新乡市康复医学重点实验室

Source(s) of funding：

Xinxiang City Key Laboratory of Rehabilitation Medicine

研究疾病：

脑卒中后偏瘫  

Target disease：

Post-stroke hemiplegia

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

观察重复经颅磁刺激联合运动想象疗法治疗脑卒中恢复期患者下肢功能及平衡功能的临床效果。  

Objectives of Study：

To observe the clinical effect of repetitive transcranial magnetic stimulation combined with motor imagery therapy in treating the lower limb function and balance function of patients in the recovery stage of stroke.

药物成份或治疗方案详述：

招募新乡医学院第一附属医院康复科住院的脑卒中恢复期步行能力障碍患者78例，按照随机数字法分为运动想象疗法组（MIT组）、经颅磁刺激组（TMS组）和联合治疗组（TMS+MIT组）。1.分组：MIT组给予常规康复治疗联合运动想象疗法，TMS组给予常规康复治疗联合重复经颅磁刺激，TMS+MIT组给予常规康复治疗、运动想象疗法联合重复经颅磁刺激治疗。 2.常规康复治疗：良肢位摆放、针灸治疗、常规运动疗法、平衡训练、神经生物反馈治疗，以上治疗均为30分钟/次，1次/天。 3.MIT训练：指导患者进行运动想象，方法如下：安静环境下进行：(1)患者想象自己处于放松环境，电动站立床保持站立位；(2)嘱患者注视前方模拟视频，受限进行前期模拟指导。进行模拟练习患侧下肢站立抬腿、屈髋、伸髋、伸膝、屈膝、踝背伸（足跟着地）基础动作的运动意象训练，持续约10分钟；(3)进行步行能力意象训练，如坐-站、向前迈步、侧向跨步等，持续5分钟（具体流程见图1）。训练时采用第一人称指导患者完成以上运动想象动作。治疗师通过标准化口头指导确保患者全身心投入，针对每位患者制定个性化训练任务，并定期检查患者对运动任务的想象能力和真实体验。每次20分钟，每日2次，连续治疗4周。治疗期间定期评估患者下肢功能恢复情况，及时记录治疗过程中出现的不良反应。 4.TMS阈值测定：刺激部位选择:患者仰卧位放松，为患者带上定位帽，在 定位帽上找到患侧头部初级运动皮层M1区的下肢运动区位置，然后将刺激线圈对准该刺激部位，先从 10% 的强度刺激开始，观察患者下肢胫前肌有无收缩，如无收缩，轻微移动刺激部位，再观察胫前肌有无收缩，如果没有任何反应，每次逐渐加大 5% 的强度，直到胫前肌出现轻微收缩，这样的刺激强度为静息运动阈值，此刺激位置为最佳刺激部位。 5.rTMS治疗：本研究重复经颅磁刺激仪器（型号XY-K-JLC-D河南翔宇医疗设备有限公司）。患者选仰卧位，将“8”字刺激线圈放置在患侧头部初级皮层运动区M1区（下肢运动区）给予10Hz高频刺激，刺激强度为静息下运动阈值80%，每次刺激 1 秒，刺激间隔 10 秒，每次治疗 100 次，总计 1000 次脉冲，共持续 20 分钟，5 次/周。共治疗 4 周。 

Description for medicine or protocol of treatment in detail：

A total of 78 patients with walking ability disorders during the recovery period of stroke who were hospitalized in the Rehabilitation Department of the First Affiliated Hospital of Xinxiang Medical University were recruited. They were randomly divided into the Movement Imagery Therapy Group (MIT group), the Transcranial Magnetic Stimulation Group (TMS group), and the Combined Treatment Group (TMS + MIT group) according to the random number method. 1. Grouping: The MIT group received conventional rehabilitation treatment combined with movement imagery therapy, the TMS group received conventional rehabilitation treatment combined with repetitive transcranial magnetic stimulation, and the TMS + MIT group received conventional rehabilitation treatment, movement imagery therapy, and repetitive transcranial magnetic stimulation combined treatment. 2. Conventional rehabilitation treatment: Good limb position placement, acupuncture treatment, conventional exercise therapy, balance training, and neurobiological feedback therapy. All of the above treatments were 30 minutes per session, once a day. 3. MIT Training: Guide patients to perform mental imagery exercises as follows: In a quiet environment: (1) Have the patient imagine themselves in a relaxed environment, with the electric standing bed remaining in the standing position; (2) Instruct the patient to gaze at the simulated video and carry out the preliminary simulation guidance under restricted conditions. Conduct movement imagery training for the basic movements of the affected side's lower limb, such as standing, lifting the leg, flexing the hip, extending the hip, extending the knee, flexing the knee, and dorsiflexion of the ankle (foot touching the ground), for approximately 10 minutes; (3) Conduct imagery training for walking ability, such as sitting-to-standing, forward stepping, lateral stepping, etc., for 5 minutes (see Figure 1). During the training, the therapist guides the patient to complete the above movement imagery actions in the first person. The therapist ensures that the patient fully engages by providing standardized verbal instructions, formulates personalized training tasks for each patient, and regularly checks the patient's imagination ability and real experience of the movement tasks. Each session lasts 20 minutes, twice a day, for a total of 4 weeks of continuous treatment. During the treatment, regularly assess the recovery of lower limb function of the patient and promptly record any adverse reactions that occur during the treatment process. 4. TMS Threshold Measurement: Stimulus Site Selection: The patient lies on their back in a relaxed position, and a positioning cap is placed on the patient. Locate the lower limb motor area of the primary motor cortex M1 of the affected side on the positioning cap, and then position the stimulation coil at this stimulation site. Start with a 10% intensity stimulation and observe if there is any contraction of the anterior tibialis muscle of the lower limb. If there is no contraction, slightly move the stimulation site and observe if there is any contraction of the anterior tibialis muscle. If there is no response, gradually increase the intensity by 5% each time until there is a slight contraction of the anterior tibialis muscle. This stimulation intensity is the resting motor threshold, and this stimulation site is the optimal stimulation site. 5. rTMS Treatment: This study uses the transcranial magnetic stimulation instrument (model XY-K-JLC-D, Henan Xiangyu Medical Equipment Co., Ltd.). The patient lies on their back, and an "8" shape stimulation coil is placed in the primary motor cortex movement area M1 of the affected side (lower limb motor area) to receive 10Hz high-frequency stimulation. The stimulation intensity is 80% of the resting motor threshold. Each stimulation lasts 1 second, with a 10-second interval between stimulations. Each treatment consists of 100 stimulations, totaling 1000 pulses, and lasts for 20 minutes. 5 times per week. A total of 4 weeks of treatment. 

纳入标准：

1.影像学证实符合脑卒中诊断标准，首次发病，意识清楚，认知功能正常； 2.年龄30-70岁之间， 3.单侧肢体运动功能障碍，症状维持2周-3月； 4.初次发病前，肢体功能恢复无异常； 5.治疗和评定过程中能够积极配合。

Inclusion criteria

1. The patient has been confirmed by imaging to meet the diagnostic criteria for stroke, with the first onset, clear consciousness, and normal cognitive function; 2. The age is between 30 and 70 years old; 3. There is unilateral limb motor dysfunction, and the symptoms have persisted for 2 weeks to 3 months; 4. Before the first onset, there was no abnormality in limb function; 5.The patient can cooperate actively during treatment and assessment.

排除标准：

（1）意识障碍； （2） 患有其他潜在神经精神系统疾病； （3）合并有重度失语或认知功能障碍； （4） 服用抗抑郁药或苯二氮?类药物； （5） 颅内金属支架或弹簧圈，肩部以上有金属植入物； （6）下肢外伤史和静脉血栓； （7）患侧下肢原有骨关节病。本研究经新乡医学院第一附属医伦理委员会批准（伦理号EC-023-638 ）。所有参与患者在研究开始前对本研究内容知情并签署知情同意书。

Exclusion criteria：

(1) Cognitive impairment; (2) Having other underlying neurological or psychiatric disorders; (3) Complicated with severe aphasia or cognitive dysfunction; (4) Taking antidepressants or benzodiazepines; (5) Having intracranial metal stents or coils, or metal implants above the shoulders; (6) History of lower limb trauma and venous thrombosis; (7) Pre-existing osteoarthritis of the affected lower limb. This study was approved by the Ethics Committee of the First Affiliated Hospital of Xinxiang Medical University (Ethics Number: EC-023-638). All participating patients were informed of the content of this study before the start of the research and signed the informed consent form.

研究实施时间：

Study execute time：

从 From 2023-06-01 00:00:00至 To 2025-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-06-15 00:00:00 至 To 2025-05-21 00:00:00

干预措施：

Interventions：

组别：

运动想象疗法组（MIT组）

样本量：

 26

Group：

The movement imagery therapy group (MIT group)

Sample size：

干预措施：

常规康复治疗+运动想象治疗

干预措施代码：

Intervention：

Conventional rehabilitation therapy + MIT therapy

Intervention code：

组别：

TMS组

样本量：

 26

Group：

TMS GROUP

Sample size：

干预措施：

常规康复治疗+经颅磁刺激治疗

干预措施代码：

Intervention：

Conventional rehabilitation therapy +TMS therapy

Intervention code：

组别：

TMS+MIT组

样本量：

 26

Group：

TMS+MIT GROUP

Sample size：

干预措施：

常规康复治疗+经颅磁刺激治疗+运动想象治疗

干预措施代码：

Intervention：

Conventional rehabilitation therapy +TMS therapy + MIT therapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河南 

市(区县)：

 新乡 

Country：

China

Province：

Henan

City：

Xinxiang

单位(医院)：

 新乡医学院第一附属医院 

单位级别：

 三甲 

Institution
hospital：

The First Affiliated Hospital of Xinxiang Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Fugl-Meyer评定量表下肢部分评分

指标类型：

主要指标

Outcome：

Fugl-Meyer assessment scale score for the lower extremities

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

功能性步行能力分类量表

指标类型：

次要指标

Outcome：

Functional Walking Ability Classification Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Berg平衡功能评分量表

指标类型：

主要指标

Outcome：

Berg Balance Function Rating Scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

None

Tissue：

NO

人体标本去向

 其它  

说明

无

Fate of sample：

0thers  

Note：

NO

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 30 岁 years
最大 Max age 70 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由新乡医学院第一附属医院康复科医生陈冲随机数字表方式，直接将受试者分配到不同组，适用于样本量较小且分组简单的研究

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

The doctors from the Rehabilitation Department of the First Affiliated Hospital of Xinxiang Medical University, using the random number table method, directly assigned the subjects to different groups. This method is suitable for studies with a small sample size and simple grouping.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

None

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）：

2026-02-01 www.medresman.org

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

2026-02-01 www.medresman.org

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：

病例记录表

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

Case Record Form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-12-04 16:10:13