ChiCTR2500095187 版本V1.0 版本创建时间2025/01/03 08:42:26 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：

 ChiCTR2500095187 

最近更新日期：

Date of Last Refreshed on：

 2025-01-03 08:42:19 

注册时间：

Date of Registration：

 2025-01-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

针刺联合物理因子治疗卒中后功能障碍的临床研究

Public title：

Clinical Study on the Combined Use of Acupuncture and Physical Therapy for Post-Stroke Functional Impairments

注册题目简写：

针刺联合物理因子治疗卒中后功能障碍的临床研究

English Acronym：

Clinical Study on the Combined Use of Acupuncture and Physical Therapy for Post-Stroke Functional Impairments

研究课题的正式科学名称：

针刺联合物理因子治疗卒中后功能障碍的临床研究

Scientific title：

Clinical Study on the Combined Use of Acupuncture and Physical Therapy for Post-Stroke Functional Impairments

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：

戴舒航 

研究负责人：

于涛 

Applicant：

Shuhang Dai  

Study leader：

Tao Yu 

申请注册联系人电话：

Applicant telephone：

 +86 180 8730 3688

研究负责人电话：

Study leader's
telephone：

+86 139 2099 9215

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：

 shuhangd24@163.com

研究负责人电子邮件：

Study leader's E-mail：

 shuhangd24@163.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：

天津中医药大学第一附属医院南院

研究负责人通讯地址：

天津中医药大学第一附属医院南院

Applicant address：

First Teaching Hosipital of Tianjin University of Traditional Chinese Medicine

Study leader's address：

First Teaching Hosipital of Tianjin University of Traditional Chinese Medicine

申请注册联系人邮政编码：

Applicant postcode：

 300381

研究负责人邮政编码：

Study leader's postcode：

 300381

申请人所在单位：

天津中医药大学第一附属医院

Applicant's institution：

First Teaching Hosipital of Tianjin University of Traditional Chinese Medicine

研究负责人所在单位：

天津中医药大学第一附属医院

Affiliation of the Leader：

First Teaching Hosipital of Tianjin University of Traditional Chinese 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：

 TYLL2024[Z]字 084

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：

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 Hosipital of Tianjin University of TCM

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-11-20 00:00:00

伦理委员会联系人：

郑子琦

Contact Name of the ethic committee：

Ziqi Zheng

伦理委员会联系地址：

天津市西青区昌凌路88号

Contact Address of the ethic committee：

No. 88 Changling Road, Xiqing District, Tianjin City

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 22 2798 6258

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：

First Teaching Hosipital 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：

No. 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：

First Teaching Hosipital of Tianjin University of Traditional Chinese Medicine

Address：

No. 88 Changling Road, Xiqing District, Tianjin

经费或物资来源：

天津市卫生计生行业高层次人才选拔培养工程-津门医学英才

Source(s) of funding：

Tianjin health and family planning industry high-level personnel selection and training project

研究疾病：

卒中  

Target disease：

stroke

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：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1.探究针刺联合重复经颅磁刺激治疗卒中后步态障碍临床疗效，通过相关量表评估临床效应，并利用fNIRS探究针刺联合小脑-大脑双靶点iTBS对偏瘫步态患者皮层网络的调控作用，对比干预前后患者执行步行任务时的皮层激活特点。 2.通过相关运动量表,任务态fNIRS检测，分关节精确评估“调阴和阳”针法结合散发式冲击波治疗脑卒中后上肢痉挛中肩关节、肘关节、腕关节、指关节的临床疗效及预后。 3.将左侧颞上回作为iTBS刺激靶点，探究iTBS结合针刺治疗卒中后失语的疗效，通过相关言语量表评估临床效应，采用近红外光谱研究失语症患者治疗前后全脑语言网络的功能连通性以及关键语言区之间的功能连接模式特征，为失语症治疗提供新的治疗方案。  

Objectives of Study：

1. Investigate the clinical efficacy of acupuncture combined with repetitive transcranial magnetic stimulation (rTMS) in treating gait disorders post-stroke. Clinical effects are assessed using relevant scales and functional near-infrared spectroscopy (fNIRS) is utilized to explore the regulatory role of acupuncture combined with cerebellar-cerebral dual-target iTBS on cortical networks in hemiplegic gait patients comparing cortical activation patterns before and after intervention during walking tasks. 2. Employing relevant physical activity scales and task-based fNIRS detection a precise joint-by-joint evaluation is conducted to assess the clinical efficacy and prognosis of the "harmonizing Yin and Yang" acupuncture method combined with radial shockwave therapy in treating upper limb spasticity post-stroke focusing on the shoulder elbow wrist and finger joints. 3. The superior temporal gyrus on the left side is targeted for iTBS stimulation to explore its combined efficacy with acupuncture in treating post-stroke aphasia. Clinical effects are evaluated using relevant speech scales and near-infrared spectroscopy is employed to study the functional connectivity of the whole-brain language network and the functional connection patterns between key language areas before and after treatment in aphasic patients offering a novel treatment approach for aphasia.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

纳入标准： ①符合脑卒中和中风病的诊断标准，经颅脑CT或MRI确诊; ②为首次发病或既往卒中未遗留明显后遗症者； ③患者生命体征平稳，能够配合相关检查及治疗 ④年龄在30-75之间； ⑤无严重脏器疾病及其他重大疾病； ⑥患者及家属知情并同意参加本次临床试验。 注：本研究纳入的患者需符合以上所有条件。 [符合以下标准者纳入步态组]： ①临床确诊因脑卒中至步态异常者； ②能短距离步行10m以上者； ③Holden步行能力分级在1级到3级之间者（包括1级及3级）。 [符合以下标准者纳入痉挛组]： ①MMSE评分＞23，听理解能力及表达能力正常； ②Brunnstrom分期在Ⅱ～IV期，上肢改良Ashworth量表分级在1-3级; [符合以下标准者纳入失语组]： ①右利手，使用中文版西方失语症量表（WAB）评估确诊为失语症（小于93.8分）； ②汉语为第一语言，小学及以上学历； ③能够独立保持坐姿30 min以上，可配合完成语言功能评估；

Inclusion criteria

Inclusion Criteria: 1. Individuals who meet the diagnostic criteria for stroke and are confirmed by cranial CT or MRI; 2. Those who have experienced their first-ever stroke or have no significant residual sequelae from a previous stroke; 3. Patients with stable vital signs who are capable of cooperating with the required examinations and treatments; 4. Individuals aged between 30 and 75 years; 5. Absence of severe organ diseases or other major illnesses; 6. Patients and their families are informed and consent to participate in this clinical trial. Note: Patients included in this study must fulfill all of the above conditions. Gait Group Inclusion Criteria: 1. Clinically diagnosed with gait abnormalities due to stroke; 2. Capable of walking a short distance of more than 10 meters; 3. Holden Walking Ability Scale classification between level 1 and level 3 (inclusive of both level 1 and level 3). Spasticity Group Inclusion Criteria: 1. Mini-Mental State Examination (MMSE) score > 23 with normal auditory comprehension and expressive abilities; 2. Brunnstrom stage II to IV and upper limb Modified Ashworth Scale classification between 1 and 3. Aphasia Group Inclusion Criteria: 1. Right-handed diagnosed with aphasia using the Chinese version of the Western Aphasia Battery (WAB) (score less than 93.8); 2. Chinese as the first language with an education level of primary school or higher; Able to independently maintain a sitting position for more than 30 minutes and can cooperate to complete language function assessments.

排除标准：

排除标准： ①中风次数 ≥3次者，双侧脑半球病变； ②伴有凝血功能障碍、出血风险无法配合检查及针刺治疗者； ③针刺部位表面及颅脑表面有破损、创伤、感染者； ④患重大脏器疾患者。 [符合以下标准者排除步态组]： ①非脑血管疾病或其它疾病至步态障碍者； ②运动性失语、视觉功能缺损等妨碍配合治疗与评价者； ③有运动功能障碍,如骨折、神经肌肉病变等影响疗效者； [符合以下标准者排除痉挛组]： ①除脑卒中原因外导致的上肢痉挛患者； ②上肢痉挛患者近3月内服用过镇静药物或肌松剂者； ③伴有严重听理解功能障碍或精神异常者； ④上肢患骨性关节、渗出性滑膜炎等疾病导致严重疼痛无法配合检查及治疗者； [符合以下标准者排除失语组]： ①因任何其他退行性或神经性疾病而导致语言障碍，如帕金森病、颅内肿瘤、颅脑外伤等； ②根据安全指南，体内有金属异物或体内植入其他电子设备不宜行rTMS治疗，如头颅内置有金属异物、耳蜗植入物、颅内压增高的患者； ③应用改变大脑皮质兴奋性的药物(抗癫痫药物)、安眠药、苯二氮?类药物等； ④有精神异常史； ⑤有癫痫病史及癫痫病家族史的患者； ⑥妊娠期或有妊娠意向的妇女、哺乳期妇女；

Exclusion criteria：

Exclusion Criteria: 1. Individuals with ≥3 strokes or bilateral cerebral hemisphere lesions; 2. Those with coagulation disorders bleeding risks that prevent cooperation with examinations and acupuncture treatment; 3. Patients with surface damage trauma or infection at acupuncture sites or on the cranial surface; 4. Individuals with severe organ diseases. Gait Group Exclusion Criteria: 1. Those with gait disorders due to non-cerebrovascular diseases or other conditions; 2. Individuals with motor aphasia visual impairments or other factors that hinder treatment cooperation and evaluation; 3. Patients with motor functional impairments such as fractures neuromuscular diseases etc. that affect treatment efficacy. Spasticity Group Exclusion Criteria: 1. Patients with upper limb spasticity due to causes other than stroke; 2. Upper limb spasticity patients who have taken sedatives or muscle relaxants within the last 3 months; 3. Individuals with severe auditory comprehension dysfunction or mental abnormalities; 4. Patients with upper limb bone and joint diseases effusive synovitis etc. causing severe pain that prevents cooperation with examinations and treatment. Aphasia Group Exclusion Criteria: 1. Those with language disorders due to any other degenerative or neurological diseases such as Parkinson's disease intracranial tumors traumatic brain injury etc.; 2. According to safety guidelines individuals with metallic foreign bodies or other electronic devices implanted in the body that are not suitable for rTMS treatment such as those with metallic foreign bodies in the skull cochlear implants or increased intracranial pressure; 3. Patients using drugs that alter cortical excitability (anti-epileptic drugs) sleeping pills benzodiazepines etc; 4. Individuals with a history of mental abnormalities; 5. Patients with a history of epilepsy and a family history of epilepsy; 6. Women who are pregnant or intend to become pregnant and nursing women.

研究实施时间：

Study execute time：

从 From 2025-01-15 00:00:00至 To 2025-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-01-15 00:00:00 至 To 2025-06-30 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 32

Group：

Experimental group

Sample size：

干预措施：

针刺联合物理因子

干预措施代码：

Intervention：

Acupuncture combined with physical factors

Intervention code：

组别：

对照组

样本量：

 32

Group：

Control group

Sample size：

干预措施：

针刺

干预措施代码：

Intervention：

Acupuncture

Intervention code：

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)：

 --请选择-- 

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：

First Teaching Hosipital of Tianjin University of Traditional Chinese Medicine

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

中文版西方失语症量表

指标类型：

主要指标

Outcome：

The western aphasia battery(WAB)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

FAC步行能力评分表

指标类型：

主要指标

Outcome：

Functional ambulation category 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量表(MAS)

指标类型：

主要指标

Outcome：

Modified Ashworth 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：

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：

尚未开始

Not yet 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）：

采用SPSS 26编号列输入1~64，使用随机数生成器，随机生成组别，数字1代表对照组，数字2代表治疗组，将生成的数字序列按顺序装入密封信封，交由一名独立于该实验的研究人员保存，根据纳排标准筛选入组患者，按入组顺序依次拆开信封，发放给研究实施人员，信封内数字为1，则该患者的组别为对照组。

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

SPSS 26 numbered columns were entered from 1 to 64, and using a random number generator, groups were randomly generated, with the number 1 representing the control group and the number 2 representing the treatment group, and the generated sequence of numbers was sequentially placed in a sealed envelope and handed over to a researcher who was independent of the experiment for safekeeping, and the patients were screened for enrollment according to the nerf criteria, and the envelopes were opened and distributed to the research implementers in the order of enrollment, and the number in the envelope was 1 , then the group of that patient was the control group.

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：

单盲

Blinding：

Single-blinded trial

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

在论文发表后于论文中公开原始数据

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

Release the raw data in the paper after 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：

①病例报告表的填写：全部病例均应按本方案规定，在完整准确书写“原始病案”的基础上，认真填写病例报告表。 ②建立数据库：临床研究单位的数据管理人员负责建立统一的数据库，指定专门研究人员收集、录入数据，试验完成后，将已记录的数据上交至课题负责人，由课题负责人管理，以便进行监控和核查。同时，交予专业统计人员一份，以便进行统计分析。

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

① Completion of the case report form: all cases should be in accordance with the provisions of this program, on the basis of complete and accurate writing of the "original case", carefully fill out the case report form. ② Establishment of a database: the data management personnel of the clinical research unit is responsible for the establishment of a unified database, designate a specialized researcher to collect and enter the data, after the completion of the test, the recorded data will be submitted to the person in charge of the subject, managed by the person in charge of the subject, in order to carry out monitoring and verification. At the same time, a copy is handed over to professional statisticians for statistical analysis.

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：

  2025-01-03 08:42:19