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Effects of motor imagery training with acupuncture on the recovery of upper extremity motor function and fNIRS in ischemic stroke patients

注册号：

Registration number：

ITMCTR2025001240

最近更新日期：

Date of Last Refreshed on：

2025-06-21

注册时间：

Date of Registration：

2025-06-21

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

运动想象结合针刺治疗对缺血性卒中患者的手功能及近红外脑功能成像的影响

Public title：

Effects of motor imagery training with acupuncture on the recovery of upper extremity motor function and fNIRS in ischemic stroke patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

运动想象结合针刺治疗对缺血性卒中患者的手功能及近红外脑功能成像的影响

Scientific title：

Effects of motor imagery training with acupuncture on the recovery of upper extremity motor function and fNIRS in ischemic stroke patients

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：

张若思

研究负责人：

金丽霞

Applicant：

Ruosi Zhang

Study leader：

Lixia Jin

申请注册联系人电话：

Applicant telephone：

18817818071

研究负责人电话：

Study leader's telephone：

13817453035

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：

zhang.ruosi@zs-hospital.sh.cn

研究负责人电子邮件：

Study leader's E-mail：

Jin.lixia@zs-hospital.sh.cn

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：

上海市徐汇区枫林路180号

研究负责人通讯地址：

上海市徐汇区枫林路180号

Applicant address：

No.180 Fenglin Road Xuhui District Shanghai

Study leader's address：

No.180 Fenglin Road Xuhui 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：

复旦大学附属中山医院

Applicant's institution：

ZhongShan Hospital Fudan University

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：

B2025-177

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

复旦大学附属中山医院医学伦理委员会

Name of the ethic committee：

Ethics Committee of Zhongshan Hospital Fudan University

伦理委员会批准日期：

Date of approved by ethic committee：

2025/4/11 0:00:00

伦理委员会联系人：

杨梦婕

Contact Name of the ethic committee：

Mengjie Yang

伦理委员会联系地址：

上海市徐汇区枫林路180号

Contact Address of the ethic committee：

No.180 Fenglin Road Xuhui District Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

02131587871

伦理委员会联系人邮箱：

Contact email of the ethic committee：

ec@zs-hospital.sh.cn

研究实施负责（组长）单位：

复旦大学附属中山医院

Primary sponsor：

ZhongShan Hospital Fudan University

研究实施负责（组长）单位地址：

上海市徐汇区枫林路180号

Primary sponsor's address：

No.180 Fenglin Road Xuhui 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)：

复旦大学附属中山医院

具体地址：

上海市徐汇区枫林路180号

Institution
hospital：

Fudan University Affiliated Zhongshan Hospital

Address：

180 Fenglin Road Xuhui District Shanghai China

经费或物资来源：

复旦大学附属中山医院

Source(s) of funding：

ZhongShan Hospital Fudan University

研究疾病：

缺血性脑卒中

研究疾病代码：

Target disease：

ischemic stroke

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：

其它

Others

研究目的：

主要目的：探索针刺结合运动想象是否能提高提高上肢功能恢复。次要目的：探索针刺是否能提高运动想象时皮质激活程度

Objectives of Study：

Main purpose: To explore whether acupuncture combined with motor imagery can enhance the recovery of upper limb function. Secondary objective: To explore whether acupuncture can enhance the degree of cortical activation during motor imagery.

药物成份或治疗方案详述：

所有参与者，无论分组如何，每周接受五次治疗，共两周10次。 实验组、对照1组、对照2组均接受常规的日常康复训练，内容包括物理治疗和作业治疗，每天持续60分钟。 实验组：在常规康复训练的基础上加用针刺治疗，取穴为合谷、外关、曲池，进针15-20mm后行针至得气（患者有刺痛、麻木和沉重感），留针20min。 对照1组：在常规康复训练的基础上加用假针治疗，在实验组相同穴位浅刺1-2mm，不得气，留针20min。 实验组和对照1组患者均在留针期间在治疗师的语音指导下进行运动想象。运动想象内容如下：第一部分（1min）：患者坐位，，要求患者闭眼、放松，尽量保持静止状态以减少不必要的运动噪声。第二部分（19min）：让患者闭眼，在治疗师语音指导下进行运动想象，以1-4步为一个任务，每个任务间休息1min，具体内容如下：1.想象五指用力伸开，然后用力握拳（1min）。2.拇指依次与食指、中指、无名指、小指进行对指（1min）3.想象坐在桌前，桌上放一水杯，伸手拿杯子喝水的动作，最后将杯子放回原位（1min）。4.想象坐在桌前，桌上放一水杯，手伸向前方的杯子，握住杯子，用力向前将水杯推离自己，直至上肢向前伸直(1min)。第三部分（1min）：把注意力集中于自己的身体，睁开眼睛，全身放松。 对照2组：在常规康复训练的基础上加用针刺治疗，方案与实验组相同，留针期间让患者放松，不进行想象活动。

Description for medicine or protocol of treatment in detail：

All participants regardless of group assignment received five treatments per week for a total of 10 sessions over two weeks. The Intervention Group Control Group 1 and Control Group 2 all received conventional daily rehabilitation training including physical therapy and occupational therapy lasting 60 minutes per day. **Experimental Group:** On the basis of conventional rehabilitation training acupuncture treatment was added. The acupoints selected were Hegu (LI4) Waiguan (SJ5) and Quchi (LI11). After inserting the needle 15–20 mm needle manipulation was performed until deqi was achieved (the patient experienced tingling numbness and heaviness) with needles retained for 20 minutes. Control Group 1: On the basis of conventional rehabilitation training sham acupuncture treatment was added. Needles were superficially inserted 1–2 mm at the same acupoints as the experimental group *without* achieving deqi with needles retained for 20 minutes. Participants in both the experimental group and Control Group 1 performed motor imagery under the therapists verbal guidance during needle retention. The motor imagery protocol was as follows: - Part 1 (1 minute): Patients sat in a chair closed their eyes relaxed and tried to remain still to reduce unnecessary movement noise. - Part 2 (19 minutes): With eyes closed patients performed motor imagery following the therapists verbal instructions. Tasks were structured in 1–4 steps with 1-minute rest between each task: 1. Imagine forcefully extending all five fingers then making a tight fist (1 minute). 2. Imagine touching the thumb to the index middle ring and little fingers in sequence (1 minute). 3. Imagine sitting at a table with a water glass reaching for the glass drinking and placing it back in its original position (1 minute). 4. Imagine sitting at a table with a water glass reaching forward to grasp the glass and pushing it away with force until the upper limb is fully extended (1 minute). - Part 3 (1 minute):Focus attention on the body open eyes and fully relax. Control Group 2: On the basis of conventional rehabilitation training acupuncture treatment identical to the experimental group was applied. During needle retention patients were instructed to relax and performed no imagery activities.

纳入标准：

1 符合第四届脑血管病会议所制定的脑梗死的诊断标准 2 年龄 30~80 岁； 3 首次发病，单侧肢体功能障碍，Brunnstrom 分期 II ~ V 期； 4 病情平稳，病程 2 周~3 个月； 5 未接受手术治疗； 6 无认知功能障碍(简易精神状态检查评分≥ 27 分)； 7 运动觉—视觉想象问卷评分（KVIQ-10）≥25 分，具有运动想象能力 8 签署知情同意书。

Inclusion criteria

Meet the diagnostic criteria for cerebral infarction established at the 4th Cerebrovascular Disease Conference Aged 30–80 years old First-time onset unilateral limb dysfunction Brunnstrom stage II–V Stable condition disease duration 2 weeks to 3 months No history of surgical treatment No cognitive impairment (MMSE score ≥27 points) Kinesthetic Visual Imagery Questionnaire score (KVIQ-10) ≥25 points with motor imagery ability Signed informed consent form

排除标准：

1 精神疾患或不能合作； 2 有严重心、肝、脑、肾等严重并发症； 3 有血小板减少症或凝血障碍性疾病； 4 上肢肌张力升高者(Ashworth 评级 2 级及以上)； 5 晕针不能接受针刺治疗

Exclusion criteria：

Mental disorders or inability to cooperate Severe complications of heart liver brain kidney etc. Thrombocytopenia or coagulation disorders Increased upper limb muscle tone (Ashworth grade ≥2 ) Fear of acupuncture and inability to accept acupuncture treatment

研究实施时间：

Study execute time：

从From 2025-04-10

至To      2025-12-31

征募观察对象时间：

Recruiting time：

从From 2025-06-30

至To      2025-09-30

干预措施：

Interventions：

组别：

实验组

样本量：

31

Group：

Intervention Group

Sample size：

干预措施：

在常规康复训练的基础上加用针刺治疗，取穴为合谷、外关、曲池，进针15-20 mm后行针至得气（患者有刺痛、麻木和沉重感），留针20min。患者在留针期间在治疗师的语音指导下进行运动想象。

干预措施代码：

Intervention：

On the basis of conventional rehabilitation training, acupuncture treatment is added. The acupoints selected are Hegu (LI4), Waiguan (SJ5), and Quchi (LI11). After inserting the needle 15-20 mm, perform needle manipulation until deqi is obtained (the patient feels tingling, numbness, and heaviness), and retain the needle for 20 minutes. During the needle retention period, the patient performs motor imagery under the verbal guidance .

Intervention code：

组别：

对照2组

样本量：

31

Group：

Control group 2

Sample size：

干预措施：

在常规康复训练的基础上加用针刺治疗，方案与实验组相同，留针期间让患者放松，不进行想象活动。

干预措施代码：

Intervention：

On the basis of conventional rehabilitation training acupuncture treatment is added with the same protocol as the experimental group. During the needle retention period the patient is instructed to relax and not perform any imagery activities.

Intervention code：

组别：

对照1组

样本量：

31

Group：

Control group 1

Sample size：

干预措施：

在常规康复训练的基础上加用假针治疗，在实验组相同穴位浅刺 1-2mm，不得气，留针 20min。患者在留针期间在治疗师的语音指导下进行运动想象。

干预措施代码：

Intervention：

On the basis of conventional rehabilitation training, sham acupuncture treatment is added. The needles are superficially inserted 1-2 mm at the same acupoints as those in the experimental group without achieving deqi, and the needles are retained for 20 minutes. During the needle retention period, the patient performs motor imagery under the verbal guidance .

Intervention code：

样本总量 Total sample size ： 93

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)：

复旦大学附属中山医院

单位级别：

三甲

Institution/hospital：

ZhongShan Hospital Fudan University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

fNIRS 数据

指标类型：

次要指标

Outcome：

functional near-infrared spectroscopy fNIRS

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

上肢运动功能评定量表（FuglMeyer assessment of upper extremity，FMA-UE）评分较基线变化量

指标类型：

主要指标

Outcome：

The change in score from baseline of the Fugl-Meyer Assessment of Upper Extremity (FMA-UE).

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

3 组中受试者中安全性评级比例

指标类型：

副作用指标

Outcome：

The proportion of subjects with safety ratings in the three groups

Type：

Adverse events

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：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 30 岁
Min age years
最大 80 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）：

采用随机数字表法。

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

The random number table method is adopted by professionals.

盲法：

Blinding：

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）：

无

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

NA

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.源数据与CRF管理：研究负责人定期核查受试者信息，确保CRF填写正确、与原始资料一致，错误/遗漏需修正并签名标注日期；完整记录治疗变更、不良事件等，严重不良事件及时报告。核查原始病案时，确认受试者纳排标准、数据一致性、评价准确性及信息真实性，临床观察表规范记录并签名。 2. 数据录入：采用EpiData3.0中文版管理93例患者基本信息、疗效指标及近红外数据，双人独立录入（非研究参与者），完成后进行一致性检测，不符项依据独立保存的原始资料修正，导出Excel存档并以SPSS 24.0 for Windows分析。

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

1. Source Data and CRF Management: The principal investigator shall periodically verify the information of subjects ensure that the CRFs are correctly filled out and consistent with the original documents. Errors or omissions must be corrected or noted and signed with dates by researchers. Treatment changes adverse events etc. shall be completely recorded and serious adverse events shall be reported in a timely manner. When verifying original medical records confirm the inclusion/exclusion criteria of subjects data consistency evaluation accuracy and information authenticity. Clinical observation forms shall be recorded in a standardized manner and signed. 2. Data Entry: EpiData 3.0 Chinese version is used to manage basic information of 93 subjects efficacy indicators and near-infrared data. Double independent entry is implemented by personnel not involved in the study. After completion consistency testing is conducted. Inconsistent items are corrected based on independently stored original documents. The data is exported to Excel for archiving and analyzed using SPSS 24.0 for Windows.

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）：

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

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