Register Now
Log In
中文/English
About ITMCTR|Search Trials|About Us|News
Effect of transcutaneous electrical acupoint stimulation on motor function recovery of upper limb spasticity after stroke

注册号：

Registration number：

ITMCTR2200005721

最近更新日期：

Date of Last Refreshed on：

2022-03-15

注册时间：

Date of Registration：

2022-03-15

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

经皮穴位电刺激对脑卒中后上肢痉挛患者运动功能恢复的影响

Public title：

Effect of transcutaneous electrical acupoint stimulation on motor function recovery of upper limb spasticity after stroke

注册题目简写：

English Acronym：

研究课题的正式科学名称：

经皮穴位电刺激对脑卒中后上肢痉挛患者运动功能恢复的影响

Scientific title：

Effect of transcutaneous electrical acupoint stimulation on motor function recovery of upper limb spasticity after stroke

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：

ChiCTR2200057642 ; ChiMCTR2200005721

申请注册联系人：

刘健

研究负责人：

刘健

Applicant：

Liu Jian

Study leader：

Liu Jian

申请注册联系人电话：

Applicant telephone：

13207676051

研究负责人电话：

Study leader's telephone：

13207676051

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：

yooken@sina.com

研究负责人电子邮件：

Study leader's E-mail：

yooken@sina.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：

天津市西青区昌凌路88号天津中医药大学第一附属医院

研究负责人通讯地址：

天津市西青区昌凌路88号天津中医药大学第一附属医院

Applicant address：

The First Teaching Hospital of Tianjin University of traditional Chinese medicine, No. 88, Changling Road, Xiqing District, Tianjin

Study leader's address：

The First Teaching Hospital of Tianjin University of traditional Chinese medicine, No. 88, Changling Road, Xiqing District, Tianjin

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：

天津中医药大学第一附属医院

Applicant's institution：

The First Teaching Hospital of Tianjin University of traditional Chinese Medicine

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：

TYLL2021[Z]字030

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：

天津中医药大学第一附属医院医学伦理委员会

Name of the ethic committee：

IRB of The First Teaching Hospital of Tianjin University of TCM

伦理委员会批准日期：

Date of approved by ethic committee：

2021/12/15 0:00:00

伦理委员会联系人：

贾景蕴

Contact Name of the ethic committee：

Jia Jingyun

伦理委员会联系地址：

天津市西青区昌凌路88号天津中医药大学第一附属医院

Contact Address of the ethic committee：

The First Teaching Hospital of Tianjin University of traditional Chinese medicine, No. 88, Changling Road, Xiqing District, Tianjin

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

天津中医药大学第一附属医院

Primary sponsor：

The First Teaching Hospital of Tianjin University of traditional Chinese Medicine

研究实施负责（组长）单位地址：

天津市西青区昌凌路88号

Primary sponsor's address：

88 Changling Road, Xiqing District, Tianjin

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

天津

市(区县)：

Country：

China

Province：

Tianjin

City：

单位(医院)：

天津中医药大学第一附属医院

具体地址：

天津市西青区昌凌路88号

Institution
hospital：

The First Teaching Hospital of Tianjin University of traditional Chinese Medicine

Address：

88 Changling Road, Xiqing District, Tianjin

经费或物资来源：

自筹

Source(s) of funding：

Self-financing

研究疾病：

脑卒中后上肢痉挛

研究疾病代码：

Target disease：

Upper limb spasm after 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：

探索性研究/预试验

Pilot clinical trial

研究目的：

初步评价经皮穴位电刺激（TEAS）对脑卒中后上肢痉挛患者运动功能恢复的有效性。

Objectives of Study：

To evaluate the efficacy of transcutaneous electrical acupoint stimulation (TEAS) in the recovery of motor function in patients with upper limb spasticity after stroke.

药物成份或治疗方案详述：

本项目为前瞻性随机、假TEAS对照、单盲临床试验，计划入组40例，每组各20例。以脑卒中后上肢痉挛患者作为研究对象，TEAS为干预手段，假TEAS为对照，治疗期为6周，随访4周。分别在治疗前、治疗中期、治疗结束后，随访4周时，针对受试者上肢的运动功能、肌肉痉挛程度、疼痛程度、生活能力等进行有效评估，初步明确TEAS对脑卒中后上肢痉挛运动功能的有效性，为临床治疗新方法提供依据。

Description for medicine or protocol of treatment in detail：

This project is a prospective randomized, sham TEAS controlled, single-blind clinical trial, with 40 cases planned to be enrolled, 20 cases in each group. Patients with upper limb spasticity after stroke were selected as the subjects, TEAS was used as the intervention method, and sham TEAS was used as the control. The treatment period was 6 weeks, and the follow-up period was 4 weeks.The motor function of upper limbs, the degree of muscle spasm, the degree of pain and the ability of daily living were evaluated before treatment, during treatment and after treatment for 4 weeks, so as to preliminarily clarify the effectiveness of TEAS in the treatment of spastic motor function of upper limbs after stroke and provide a basis for new clinical treatment.

纳入标准：

1、符合西医诊断标准：参照2018年中华医学会神经病学分会脑血管病学组制定的《中国急性缺血性脑卒中诊治指南》中脑梗死的诊断标准，全部病例均经CT或 MRI确诊； 2、符合中医诊断标准：参照中华中医药学会发布的《中医内科常见病诊疗指南》—中风病（ZYYXH/T22- 2008）； 3、发病时间在6个月-12个月； 4、上肢痉挛，20≤FMA-UE≤50； 5、年龄在30到75周岁之间； 6、生命体征平稳，意识清楚，语言交流无明显障碍，认知功能基本正常； 7、患者或者家属签署知情同意。

Inclusion criteria

1. In line with the diagnostic criteria of Western medicine: referring to the diagnostic criteria of cerebral infarction in the Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke in China formulated by the Cerebrovascular Disease Group of the Neurology Society of the Chinese Medical Association in 2018, all cases were diagnosed by CT or MRI; 2. In line with the diagnostic criteria of traditional Chinese medicine: refer to the Guidelines for Diagnosis and Treatment of Common Diseases in Internal Medicine of Traditional Chinese Medicine-Stroke (ZYYXH/T22-2008) issued by the Chinese Society of Traditional Chinese Medicine; 3. The onset time was 6 months to 12 months; 4. Upper limb spasm, 20 ≤ FMA-UE ≤ 50; 5. Age between 30 and 75 years old; 6. The vital signs are stable, the consciousness is clear, the language communication has no obvious obstacle, and the cognitive function is basically normal; 7. Informed consent signed by the patient or family members.

排除标准：

1、此次脑卒中发作前有上肢痉挛者； 2、其他神经系统病变所致上肢痉挛者； 3、伴有类风湿、骨折、外伤、关节病变等影响肢体运动功能的其他疾病； 4、有复发死亡高危风险者； 5、合并精神疾患或严重的心、肝、肾等重要脏器功能不全及造血系统、内分泌系统等严重原发疾病患者； 6、有经皮穴位电刺激禁忌症（如电子植入物），或有恐惧心理，根据医生判断容易造成失访者； 7、选穴部位有感染、溃疡、瘢痕患者； 8、合并妊娠或哺乳期妇女； 9、本研究期内应用针灸推拿疗法、康复疗法、电或磁刺激疗法、肌肉松弛剂、注射肉毒素A等治疗方法可能影响本研究疗效判断者。

Exclusion criteria：

1. Patients with upper limb spasm before the onset of stroke; 2. Upper limb spasm caused by other nervous system diseases; 3. Other diseases that affect the motor function of limbs, such as rheumatoid, fracture, trauma and joint lesions; 4. Those with high risk of recurrence and death; 5. Patients with mental disorders or severe dysfunction of important organs such as heart, liver and kidney, as well as severe primary diseases such as hematopoietic system and endocrine system; 6. There are contraindications to transcutaneous electrical acupoint stimulation (such as electronic implants), or fear, which is easy to cause loss of visitors according to the doctor's judgment; 7. Patients with infection, ulcer and scar at selected acupoints; 8. Women with pregnancy or lactation; 9. During the study period, the application of acupuncture and massage therapy, rehabilitation therapy, electrical or magnetic stimulation therapy, muscle relaxants, botulinum toxin A injection and other treatment methods may affect the judgment of the efficacy of the study.

研究实施时间：

Study execute time：

从From 2021-12-01

至To      2023-09-01

征募观察对象时间：

Recruiting time：

从From 2022-03-07

至To      2022-09-16

干预措施：

Interventions：

组别：

假TEAS组

样本量：

20

Group：

Sham TEAS group

Sample size：

干预措施：

对患侧上肢穴位进行假经皮穴位电刺激

干预措施代码：

Intervention：

Pseudo-transcutaneous electrical acupoint stimulation of the affected upper limb acupoints

Intervention code：

组别：

TEAS组

样本量：

20

Group：

TEAS group

Sample size：

干预措施：

对患侧上肢穴位进行经皮穴位电刺激

干预措施代码：

Intervention：

Transcutaneous electrical acupoint stimulation of the affected upper limb acupoints

Intervention code：

样本总量 Total sample size ： 40

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

天津

市(区县)：

Country：

China

Province：

Tianjin

City：

单位(医院)：

天津中医药大学第一附属医院

单位级别：

三级

Institution/hospital：

The First Teaching Hospital of Tianjin University of traditional Chinese Medicine

Level of the institution：

Grade III

测量指标：

Outcomes：

指标中文名：

有效改善率

指标类型：

次要指标

Outcome：

Effective improvement rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肌肉肌电活动

指标类型：

次要指标

Outcome：

Myoelectric activity of muscle

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肌肉痉挛程度

指标类型：

次要指标

Outcome：

Degree of muscle spasm

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Fugl-Meyer运动功能评分

指标类型：

主要指标

Outcome：

Upper limb Fugl-Meyer assessment

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

运动功能

指标类型：

次要指标

Outcome：

Motor function

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

日常生活能力

指标类型：

次要指标

Outcome：

Ability of daily living

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疼痛程度

指标类型：

次要指标

Outcome：

Degree of pain

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：

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 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）：

由不参与本研究的第三方程序员，采用SPSS 21.0软件设定人数后产生随机数字对患者随机分入TEAS组和假TESA组。

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

Patients were randomly assigned to TEAS and sham TEAS by a third party programmer who was not involved in the study and used SPSS 21.0 to generate random numbers after setting the number of patients.

盲法：

对受试者、结局评价者、数据分析者设盲。患者不知道所接受的治疗方案；结局评价由不知分组情况的研究者负责；数据分析由不参与本研究的第三方人员负责。

Blinding：

Subjects, outcome evaluators, and data analysts were blinded. Patients were unaware of the treatment regimens received; outcome evaluation was performed by investigators who were unaware of the grouping; and data analysis was performed by third parties who were not involved in the study.

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）：

试验完成后，统计学结果上传到临床试验公共管理平台 ResMan (www.medresman.org) ，一年后公布结果。

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

After the trial was completed, the statistical results were uploaded to ResMan (www.medresman.org), a public management platform for clinical trials, and the results were published one year later

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：

每个入选病例必须完成病例报告表，病例报告表由研究者填写。完成的病例报告表由临床监查员审查后，采用临床试验公共平台ResMan管理。

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

Each selected case must complete a case report form, which shall be filled in by the investigator. The completed case report form is reviewed by the clinical supervisor and managed by the clinical trial public platform ResMan.

数据管理委员会：

Data Managemen Committee：

有

Yes

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):

back
Platform information
About ITMCTR
About Us
Register Trials
Frequently Asked Questions
Ethical Review
The public service
Search Trials
Join Us
ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above