ChiCTR2400081781 版本V1.0 版本创建时间2024/03/12 08:41:15 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：

 ChiCTR2400081781 

最近更新日期：

Date of Last Refreshed on：

 2024-03-12 08:41:10 

注册时间：

Date of Registration：

 2024-03-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于表面肌电技术研究电针治疗脑梗死偏瘫侧上肢软瘫期运动障碍的临床观察及作用机制评价

Public title：

To study the clinical observation and mechanism evaluation of electroacupuncture in the treatment of hemiplegic upper limb dyskinesia in cerebral infarction based on surface electromyography

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于表面肌电技术研究电针治疗脑梗死偏瘫侧上肢软瘫期运动障碍的临床观察及作用机制评价

Scientific title：

To study the clinical observation and mechanism evaluation of electroacupuncture in the treatment of hemiplegic upper limb dyskinesia in cerebral infarction based on surface electromyography

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：

张韶婷  

研究负责人：

赵宏波 

Applicant：

Shaoting Zhang 

Study leader：

Hongbo Zhao 

申请注册联系人电话：

Applicant telephone：

 +86 133 6320 6851

研究负责人电话：

Study leader's
telephone：

+86 188 1046 5676

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：

 m13363206851@163.com

研究负责人电子邮件：

Study leader's E-mail：

 172361285@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：

北京市石景山区八大处西下庄北京康复医院

研究负责人通讯地址：

北京市石景山区八大处西下庄北京康复医院

Applicant address：

Beijing Rehabilitation Hospital, Xixiazhuang, Badachu, Shijingshan District, Beijing

Study leader's address：

Beijing Rehabilitation Hospital, Xixiazhuang, Badachu, Shijingshan District, Beijing

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：

首都医科大学北京康复医学院

Applicant's institution：

Capital Medical University School of Beijing Rehabilitation Medicine

研究负责人所在单位：

首都医科大学附属北京康复医院,首都医科大学北京康复医学院

Affiliation of the Leader：

Beijing Rehabilitation Hospital, Capital Medical University ,Capital Medical University School of Beijing Rehabilitation Medicine

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：

 2024bkky-055

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：

首都医科大学北京康复医院伦理委员会

Name of the ethic committee：

Ethics Committee of Beijing Rehabilitation Hospital, Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-03-05 00:00:00

伦理委员会联系人：

王婷

Contact Name of the ethic committee：

Wang Ting

伦理委员会联系地址：

首都医科大学附属北京康复医院

Contact Address of the ethic committee：

Beijing Rehabilitation Hospital, Capital Medical University

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 188 1091 2032

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：

首都医科大学附属北京康复医院

Primary sponsor：

Beijing Rehabilitation Hospital, Capital Medical University

研究实施负责（组长）单位地址：

北京市石景山区八大处西下庄北京康复医院

Primary sponsor's address：

Beijing Rehabilitation Hospital, Xixiazhuang, Badachu, Shijingshan District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

首都医科大学附属北京康复医院

具体地址：

北京市石景山区八大处西下庄北京康复医院

Institution
hospital：

Beijing Rehabilitation Hospital, Capital Medical University

Address：

Beijing Rehabilitation Hospital, Xixiazhuang, Badachu, Shijingshan District, Beijing

经费或物资来源：

首都医科大学

Source(s) of funding：

Capital Medical University

研究疾病：

脑梗死  

Target disease：

cerebral infarction

研究疾病代码：

ICD-10

Target disease code：

ICD-10

研究类型：

治疗研究

Study type：

Treatment study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

本研究主要观察电针对脑梗死偏瘫侧上肢软瘫期运动障碍的临床疗效。与普通针刺治疗进行比较，观察两组患者偏瘫侧上肢肌力、肌张力等方面的疗效差异。选用相应康复评估量表、表面肌电图（surface electromyography, sEMG）等作为观察指标，客观评估两组间的疗效差异。  

Objectives of Study：

The purpose of this study is to observe the clinical effect of electrotherapy on the movement disorder of upper limb of hemiplegic side in cerebral infarction. Compared with ordinary acupuncture treatment, the efficacy of hemiplegic upper limb muscle strength, muscle tension and other aspects were observed between two groups. The corresponding rehabilitation assessment scale and surface electromyography (sEMG) were used as observation indexes to objectively evaluate the difference in efficacy between the two groups.

药物成份或治疗方案详述：

1.1.研究类别：单中心平行随机对照研究。 1.2研究对象：脑梗死偏瘫侧软瘫期上肢运动功能障碍患者。 1.3分组方法：采用随机数字表法，将患者随机分为对照组和试验组，每组各31例。 1.4干预方法及疗程：在基础治疗和康复治疗的基础上，对照组和试验组分别给予普通针刺治疗和电针治疗。针刺穴位包括，头部穴位：病灶侧前顶穴、悬厘穴、通天穴、正营穴，上肢穴位：偏瘫侧极泉、肩髃、曲池、内关、合谷；针法包括：头针和上肢体针，作用于患者肢体，电针治疗与普通针刺进行对比，观察其临床疗效和可能存在的作用机制。 治疗周期为4周，每次针刺30分钟，每周治疗5次，由8年以上工作经验的针灸医师进行操作。基础治疗包括：控制血糖、血压、血脂，抗血小板聚集、活血化瘀等；康复治疗包括：上肢被动训练、上肢综合康复训练、中频治疗、四肢联动等。 1.5观察指标：主要指标（上肢FMA评定量表评分）；次要指标（Brunnstrom分期量表，改良Ashworth分级评分，表面肌电图检查（肱二头肌、肱三头肌、斜方肌、三角肌前束））。 研究项目完成后1月，进行随访，进一步评估患者疗效，随访评估内容包括：上肢FMA评定量表评分、Brunnstrom分期量表评分和改良Ashworth分级评分。 1.6临床研究过程中质量控制措施 电针具体操作，选穴与消毒：电针选穴与毫针选穴基本相同，选穴后要采取适当的体位以防止患者改变姿势而影响准确性；消毒方法宜先用碘酒消毒，后用酒精棉球脱碘，防止感染。电针参数：体针穴位针刺得气后，采用2Hz的连续波电针刺激，电流强度以患者穴位肌肉收缩，患者能够耐受为度，刺激30分钟，起到舒经活络、调和气血、扩张血管、促通神经等作用。 顶颞前斜线：针尖先自前顶穴沿头皮向悬厘穴方向刺入1-1.2寸，第2针接着第1针之针尖处下针，用同样方法进针1-1.2寸，以后数针如上法，直至最后1针针尖刺至悬厘穴为止，针感以局部紧胀感为度，捻针刺激200转/分钟，留针30分钟；顶旁1线：针尖自通天穴头皮由前向后捻转刺入达1.5寸，以局部紧胀感为度，捻针刺激200转/分钟，留针30分钟；顶旁2线：针尖自正营穴迅速沿头皮由前向后捻转刺入达1.5寸，以局部紧胀感为度，捻针刺激200转/分钟，留针30分钟。 极泉：在原穴下1寸处，直刺1-1.5寸，施提插泻法，以患侧上肢抽动3次为度，刺激腋筋膜及局部神经；肩髃：向臂臑方向针刺，深度1.5-2寸，刺激三角肌，酸胀感扩散至肩关节周围；曲池：向尺泽方向针刺，深度1-1.5寸，刺激肱桡肌和桡神经，局部酸胀或向上放散至肩部或向下放散至手指；内关：向外关方向针刺，深度1-1.5寸，刺激指伸肌群（小指伸肌、指伸肌、拇长伸肌和食指伸肌），手掌酸麻感并向手背放散，引起手背伸；合谷：向后溪方向针刺，深度1.5-2寸，手掌酸麻并向食指端放散，刺激第1骨间背侧肌、拇收肌、桡神经浅支、尺神经深支；具体针刺深度视病人的胖瘦和肌肉丰厚程度灵活设置。 

Description for medicine or protocol of treatment in detail：

1.1. Study type: Single-center parallel randomized controlled study. 1.2 Subjects: Patients with upper limb motor dysfunction during cerebral infarction hemiplegic side soft paralysis. 1.3 Grouping method: Patients were randomly divided into control group and treatment group by random number table method, with 31 cases in each group. 1.4 Intervention methods and course of treatment: On the basis of basic treatment and rehabilitation treatment, the control group and the treatment group were given ordinary acupuncture treatment and electroacupuncture treatment, respectively. Acupuncture points include: head points: focus side Qianding point, Xuanli point, Tongtian point, Zhengying point, upper extremity points: hemiplegic side Jiquan, Jianyu, Quchi, Neiguan, Hegu; Acupuncture methods include: head acupuncture and upper body acupuncture, which act on the limbs of patients. Electroacupuncture treatment is compared with ordinary acupuncture, and its clinical efficacy and possible mechanism of action are observed. The treatment period was 4 weeks, 30 minutes each time, 5 times a week, and was performed by acupuncturists with more than 8 years of working experience. Basic treatment includes: control of blood sugar, blood pressure, blood lipids, anti-platelet aggregation, blood circulation and blood stasis; Rehabilitation treatment includes: upper limb passive training, upper limb comprehensive rehabilitation training, medium frequency treatment, limb linkage and so on. 1.5 Outcome measures: Main indicators (upper limb FMA rating scale score); Secondary indicators (Brunnstrom staging scale, modified Ashworth rating, surface electromyography (biceps, triceps, trapezius, deltoid anterior bundle)). Follow-up was performed 1 month after the completion of the study project to further evaluate the efficacy of the patients. Follow-up evaluation included: upper limb FMA rating scale score, Brunnstrom stage scale score and modified Ashworth rating score. 1.6 Quality control measures during clinical research The specific operation, point selection and disinfection of electroacupuncture: the point selection of electroacupuncture is basically the same as that of milliacupuncture, and appropriate posture should be taken after the point selection to prevent patients from changing their posture and affecting the accuracy; The disinfection method should be disinfected with iodine first, and then deiodized with alcohol cotton balls to prevent infection. Electroacupuncture parameters: After the body acupuncture point obtains qi, 2Hz continuous wave electroacupuncture stimulation is used. The current intensity is based on the muscle contraction of the patient's acupoint, and the patient can tolerate it. The stimulation is performed for 30 minutes, which plays the role of relaxing the meridian, regulating the qi and blood, dilating blood vessels, promoting the nerves, etc. Anterior parietotemporal diagonal line: Needle tip first from the qianding point along the scalp to the direction of Xuanli point 1-1.2 inches, the second needle followed by the first needle at the tip of the needle, using the same method into the needle 1-1.2 inches, after the number of needles as above, until the last needle tip to Xuanli point, the needle feeling is local tight swelling, twist the needle to stimulate 200 RPM, leave the needle for 30 minutes; 1 line near the top: the tip of the needle is twisted from front to back and inserted into the skin of Tongtian acupoint up to 1.5 inches, with local tight swelling as the degree, twist the needle to stimulate 200 RPM, leave the needle for 30 minutes; 2 lines near the top: the tip of the needle from Zhengying point quickly along the scalp from front to back twist into the puncture up to 1.5 inches, with the local sense of swelling as the degree, twist the needle to stimulate 200 RPM, leave the needle for 30 minutes. Ji Quan: 1 inch below the original point, direct acupuncture 1-1.5 inches, perform lifting and thrusting and diarrhea, with the affected upper limb twitching 3 times as the degree, stimulate the axillary fascia and local nerves; Shoulder Condyle: Acupuncture point to arm , depth 1.5-2 inches, stimulated deltoid muscle, acid distension spread to around shoulder joint; Qu Chi: Acupuncture in the guze direction, the depth of 1-1.5 inches, stimulate the brachioradialis muscle and radial nerve, local acid distension or release upward to the shoulder or downward to the finger; Neiguan: Acupuncture in the outward direction of the Guan, with a depth of 1-1.5 inches, stimulates the extensor muscles of the finger (extensor of the little finger, extensor of the finger, extensor of the thumb long and extensor of the index finger), and causes numbness in the palm and release to the back of the hand, causing the back of the hand to extend; Hegu: Acupuncture in the direction of the back river, the depth is 1.5-2 inches, the palm is numb and released to the index finger, stimulate the first interosseous dorsal muscle, the adductor polis, the superficial branch of the radial nerve, the deep branch of the ulnar nerve; The specific acupuncture depth is flexibly set according to the patient's fat and lean and muscle fat degree. 

纳入标准：

（1）首次发病，病灶位于一侧大脑半球，伴有一侧肢体偏瘫； （2）符合以上中、西医有关脑梗死的诊断标准，并且得到CT或者MRI等影像学的证实，发病时间在1个月到6个月之间者； （3）患侧上肢布式分期为I期软瘫者； （4）年龄在30-75岁之间，男女不限； （5）意识清醒，生命体征平稳者； （6）不存在其他急性疾病以及严重的并发症； （7）自愿参加本研究项目并签署知情同意书者。

Inclusion criteria

(1) First onset, the lesion is located in one cerebral hemisphere, accompanied by one limb hemiplegia. (2) Those who meet the above diagnostic criteria of Chinese and Western medicine related to cerebral infarction, and have been confirmed by CT or MRI and other images, and the onset time is between 1 month and 6 months. (3) Patients with stage I soft paralysis of the affected upper limb. (4) Age 30-75 years old, male or female. (5) Patients with clear consciousness and stable vital signs. (6) There are no other acute diseases and serious complications. (7) Volunteer to participate in the research project and sign the informed consent.

排除标准：

（1）属于短暂性脑缺血发作的患者； （2）病变部位涉及双侧大脑半球的患者； （3）尚处于急性期昏迷，存在严重脑病、或者并发心肌梗塞疾病、或兼有严重肝肾功能障碍疾病、重症感染、严重的糖尿病等情况的患者； （4）存在痴呆的患者，或感觉性失语症状较严重者； （5）晕针，不能配合针灸者；或入组前已经开始本实验方案系统干预1周以上者; （6）精神病患者。

Exclusion criteria：

(1) Patients with transient ischemic attack. (2) Patients with lesions involving bilateral cerebral hemispheres. (3) Patients who are still in acute coma, have serious encephalopathy, or complicated myocardial infarction, or have severe liver and kidney dysfunction, severe infection, serious diabetes, etc. (4) Patients with dementia, or those with severe sensory aphasia symptoms. (5) Dizzy needles, cannot cooperate with acupuncture; Or had started the systematic intervention of the experimental protocol for more than 1 week before enrollment. (6) Mental patients.

研究实施时间：

Study execute time：

从 From 2024-01-01 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-03-18 00:00:00 至 To 2024-12-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 31

Group：

Experimental group

Sample size：

干预措施：

电针治疗

干预措施代码：

Intervention：

electroacupuncture treatment

Intervention code：

组别：

对照组

样本量：

 31

Group：

Control Group

Sample size：

干预措施：

普通针刺治疗

干预措施代码：

Intervention：

General acupuncture treatment

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 首都医科大学附属北京康复医院 

单位级别：

 三级 

Institution
hospital：

Beijing Rehabilitation Hospital, Capital Medical University

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

上肢FMA评定量表

指标类型：

主要指标

Outcome：

Upper limb FMA rating scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

改良Ashworth分级量表

指标类型：

次要指标

Outcome：

Modified Ashworth rating 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：

Brunnstrom分期量表

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：

指标中文名：

表面肌电图检查

指标类型：

次要指标

Outcome：

Surface electromyography

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：

None

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 30 岁 years
最大 Max age 75 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）：

利用随机数字表进行随机分组。在随机数字表中随机挑选一个数字，从该数往后数62个数字，将这62个数字除以2，能被整除的归为一组，不能被整除的归为另一组。

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

Random grouping is performed using a random number table. Select a random number in the random number table, count 62 numbers from the number, divide the 62 numbers by 2, can be divided into one group, can not be divided into another group.

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）：

我们将在文章发表1年内在网络平台公开分享。

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

We will share the article publicly on the online platform within 1 year of publication.

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：

采用病历记录表收集数据。

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

Data were collected 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：

  2024-03-12 08:41:10