中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600117768
最近更新日期： Date of Last Refreshed on：	2026-01-28 15:47:54
注册时间： Date of Registration：	2026-01-28 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	基于滑动窗口的脑卒中偏瘫患者运动训练注意力状态的特征分析
Public title：	Characteristic analysis of the attention state of stroke hemiplegic patients during motor training based on Sliding window
注册题目简写：
English Acronym：
研究课题的正式科学名称：	基于滑动窗口的脑卒中偏瘫患者运动训练注意力状态的特征分析
Scientific title：	Characteristic analysis of the attention state of stroke hemiplegic patients during motor training based on Sliding window
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：	周少婷	研究负责人：	周少婷
Applicant：	Shaoting Zhou	Study leader：	Shaoting Zhou
申请注册联系人电话： Applicant telephone：	+86 173 1735 4355	研究负责人电话： Study leader's telephone：	+86 173 1735 4355
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：	240146537@qq.com	研究负责人电子邮件： Study leader's E-mail：	240146537@qq.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：	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：	No. 2209, Guangxing Road, Songjiang District, Shanghai	Study leader's address：	No. 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), Tongji University School of Medicine, Shanghai, 201619, China
研究负责人所在单位：	上海市养志康复医院(上海市阳光康复中心)
Affiliation of the Leader：	Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center), Tongji University School of Medicine, Shanghai, 201619, China

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：	养志伦审字(2025)008号	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：	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：	2025-02-01 00:00:00
伦理委员会联系人：	王笑凡
Contact Name of the ethic committee：	Xiaofan Wang
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：	No. 2209, Guangxing Road, Songjiang District, Shanghai
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 183 2187 5361	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：

上海市养志康复医院（上海市阳光康复中心）

Primary sponsor：

Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center), Tongji University School of Medicine, Shanghai, 201619, China

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：

No. 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(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海市养志康复医院（上海市阳光康复中心）	具体地址：	上海市松江区光星路2209号
Institution hospital：	Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center), Tongji University School of Medicine, Shanghai, 201619, China	Address：	No. 2209, Guangxing Road, Songjiang District, Shanghai

经费或物资来源：

上海市养志康复医院（上海市阳光康复中心）阳光临床研究培育项目2024CRTS003

Source(s) of funding：

Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center), Tongji University School of Medicine, Shanghai, 201619, China. Sunshine Clinical Cultivation Project 2024CRTS003

研究疾病：

脑卒中

Target disease：

Stroke

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

横断面

Study design：

Cross-sectional

研究目的：

本研究使用 fNIRS 实时评估不同运动训练模式对滑动窗口内-运动皮层兴奋性的影响，探索不同训练模式皮层效应的差异，为根据不同功能状态患者制定合适的运动训练模式提供参考，也为无创神经调控联合注意力针对不同运动训练的高效性提供理论支撑。

Objectives of Study：

This study used fNIRS to evaluate in real time the effects of different exercise training modes on the excitability of the in-sliding window - motor cortex, explore the differences in cortical effects among different training modes, provide a reference for formulating appropriate exercise training modes for patients with different functional states, and also offer theoretical support for the efficiency of non-invasive neuroregulation combined with attention in different exercise training.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

(1) Those who fully understand the experimental content, voluntarily participate, and have their written informed consent signed by themselves or their authorized agents; 
(2) Those who meet the diagnostic criteria for ischemic stroke in the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018" or the diagnostic criteria for cerebral hemorrhage in the "Chinese Guidelines for the Diagnosis and Treatment of Cerebral Hemorrhage (2019)"; 
(3) Those with a single stroke indicated by head CT or MR, or those who have had lacunar infarction in the past without sequelae; 
(4) Those with unilateral hemiplegia; 
(5) Hypertonia of the flexor muscles of the elbow and/or wrist on the hemiplegic side of the upper limb when standing in a natural position, with a MAS score of 1 or more; 
(6) Those who are 18 years old or older and 85 years old or younger; 
(7) Those whose stroke onset date is greater than or equal to one calendar month away from the date of the first assessment; 
(8) Those whose listening comprehension and cognitive abilities can cooperate to complete the inspection instructions.

排除标准：

（1）既往存在可引起运动功能障碍的疾病患者，包括但不限于帕金森病；（2）头颅CT或MR提示多次脑卒中，或既往发生腔隙性脑梗死有后遗症者；（3）双侧肢体受累者；（4）有严重听力障碍、听理解障碍、认知障碍、精神障碍等导致无法配合完成检查指令者；（5）既往存在引起患侧或健侧上肢肘关节、腕关节活动度受限疾病患者，包括但不限于类风湿性关节炎、骨关节炎、关节手术史等；（6）既往存在影响患侧或对侧肌皮神经、正中神经的外周神经疾病患者，包括但不限于臂丛损伤、颈神经根病等；（7）患侧或对侧上肢皮肤存在感染、破溃、炎症等影响电极片贴放者；（8）颅骨不完整的偏瘫患者；（9）Brunnstrom患侧肢体上肢分期小于3期。

Exclusion criteria：

(1) Patients with a history of diseases that can cause motor dysfunction, including but not limited to Parkinson's disease; (2) Those with multiple strokes indicated by head CT or MR, or those with sequelae from previous lacunar cerebral infarction; (3) Those with bilateral limb involvement; (4) Those who have severe hearing impairment, auditory comprehension impairment, cognitive impairment, mental disorder, etc., which prevent them from cooperating to complete the examination instructions; (5) Patients with a history of diseases that cause limited range of motion in the elbow or wrist joints on the affected or healthy side of the upper limb, including but not limited to rheumatoid arthritis, osteoarthritis, and a history of joint surgery, etc. (6) Patients with a history of peripheral nerve diseases that affect the musculocutaneous nerve or median nerve on the affected or contralateral side, including but not limited to brachial plexus injury, cervical nerve root disease, etc. (7) Where there is infection, ulceration, inflammation or other conditions on the skin of the affected or contralateral upper limb that affect the placement of electrode patches; (8) Hemiplegic patients with incomplete skulls; (9) Brunnstrom's stage of the upper limb on the affected side is less than stage 3.

研究实施时间：

Study execute time：

从 From 2026-02-01 00:00:00至 To 2026-12-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-02-01 00:00:00 至 To 2026-12-01 00:00:00

干预措施：

Interventions：

组别：	观察组	样本量：	35
Group：	Observation group	Sample size：	35
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	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
Institution hospital：	Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center), Tongji University School of Medicine, Shanghai, 201619, China	Level of the institution：	Tertiary

测量指标：

Outcomes：

指标中文名：	近红外脑功能成像	指标类型：	主要指标
Outcome：	fNIRS	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Fugl-Meyer评估量表	指标类型：	次要指标
Outcome：	FMA	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Brunnstrom分期评定量表	指标类型：	次要指标
Outcome：	Brunnstrom Staging Scale	Type：	Secondary 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：
Sample Name：	No	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	85	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）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是Yes
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年12月01日采用网络平台https://www.shygkf.org.cn/lxwm/index_36.aspx
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	On February 1, 2026, a network platform will be adopted
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：	本试验拟采用电子数据收集系统（Electronic Data Capture，EDC）完成试验数据的收集和管理。EDC系统经过严格测试，满足《医疗器械临床试验质量管理规范》及《临床试验数据管理工作技术指南》的相关要求。系统正式上线前，需要对相关使用人员进行培训测试，确保系统满足试验需求。而在正式上线后，相关人员将会得到账号和密码，账户绑定了用户的角色和权限，必须妥善保管账户信息，不得将账号信息告知他人或替他人行使相应权利。实验原始数据从仪器导出为后，使用Homer2软件进行数据处理。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	This experiment intends to adopt the Electronic Data Capture (EDC) system to complete the collection and management of the experimental data. The EDC system has undergone rigorous testing and meets the relevant requirements of the "Good Clinical Practice for Medical Devices" and the "Technical Guidelines for Clinical Trial Data Management". Before the system is officially launched, it is necessary to conduct training and testing for the relevant users to ensure that the system meets the trial requirements. After the official launch, relevant personnel will receive an account and password. The account is bound to the user's role and permissions, and the account information must be properly kept. It is not allowed to disclose the account information to others or exercise the corresponding rights on behalf of others. After the original experimental data was exported from the instrument, the Homer2 software was used for data processing.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2026-01-28 15:47:50