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Research on the Rehabilitation Efficacy and Safety of Acupuncture Treatment Combined with Intermittent Theta Burst Stimulation (iTBS) for Upper Limb Motor Dysfunction in Stroke Patients: A Multicenter Randomized Controlled Trial.

注册号：

Registration number：

ITMCTR2025000280

最近更新日期：

Date of Last Refreshed on：

2025-02-16

注册时间：

Date of Registration：

2025-02-16

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

针灸治疗联合iTBS对脑卒中患者上肢运动功能障碍的康复效果、安全性研究:一项多中心随机对照试验

Public title：

Research on the Rehabilitation Efficacy and Safety of Acupuncture Treatment Combined with Intermittent Theta Burst Stimulation (iTBS) for Upper Limb Motor Dysfunction in Stroke Patients: A Multicenter Randomized Controlled Trial.

注册题目简写：

iTBS对脑卒中患者上肢运动功能障碍的疗效研究

English Acronym：

Research on the Efficacy of Intermittent Theta Burst Stimulation (iTBS) in Treating Upper Limb Motor Dysfunction in Stroke Patients

研究课题的正式科学名称：

针灸治疗联合iTBS对脑卒中患者上肢运动功能障碍的康复效果、安全性研究:一项多中心随机对照试验

Scientific title：

Research on the Rehabilitation Efficacy and Safety of Acupuncture Treatment Combined with Intermittent Theta Burst Stimulation (iTBS) for Upper Limb Motor Dysfunction in Stroke Patients: A Multicenter Randomized Controlled Trial.

研究课题的正式科学名称简写：

iTBS对脑卒中患者上肢运动功能障碍的疗效研究

Scientific title acronym：

Research on the Efficacy of Intermittent Theta Burst Stimulation (iTBS) in Treating Upper Limb Motor Dysfunction in Stroke Patients

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：

贾瑶

研究负责人：

贾瑶

Applicant：

Jia Yao

Study leader：

Jia Yao

申请注册联系人电话：

Applicant telephone：

+86 151 2949 9218

研究负责人电话：

Study leader's telephone：

+86 151 2949 9218

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：

501925133@qq.com

研究负责人电子邮件：

Study leader's E-mail：

501925133@qq.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：

陕西省商洛市商州区商鞅大道中段37号商洛市中心医院

研究负责人通讯地址：

陕西省商洛市商州区商鞅大道中段37号商洛市中心医院

Applicant address：

Shangluo Central Hospital, No. 37 Shangyang Road, Shangzhou District, Shangluo, Shaanxi Province

Study leader's address：

Shangluo Central Hospital No. 37 Shangyang Road Shangzhou District Shangluo Shaanxi Province

申请注册联系人邮政编码：

Applicant postcode：

726000

研究负责人邮政编码：

Study leader's postcode：

726000

申请人所在单位：

商洛市中心医院

Applicant's institution：

Shangluo Central Hospital

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：

KY2024012

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：

商洛市中心医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Shangluo Central Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024/10/8 0:00:00

伦理委员会联系人：

张璐

Contact Name of the ethic committee：

Zhang Lu

伦理委员会联系地址：

陕西省商洛市商州区商鞅大道中段37号商洛市中心医院

Contact Address of the ethic committee：

Shangluo Central Hospital No. 37 Shangyang Road Shangzhou District Shangluo Shaanxi Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 0914 298 2587

伦理委员会联系人邮箱：

Contact email of the ethic committee：

526462485@qq.com

研究实施负责（组长）单位：

商洛市中心医院

Primary sponsor：

Shangluo Central Hospital

研究实施负责（组长）单位地址：

陕西省商洛市商州区商鞅大道中段37号

Primary sponsor's address：

No. 37 Middle Section of Shangyang Avenue Shangzhou District Shangluo Shaanxi Province.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

陕西省

市(区县)：

商洛市

Country：

China

Province：

Shaanxi Province

City：

Shangluo

单位(医院)：

商洛市中心医院

具体地址：

陕西省商洛市商州区商鞅大道中段37号

Institution
hospital：

Shangluo Central Hospital

Address：

No. 37 Middle Section of Shangyang Avenue Shangzhou District Shangluo Shaanxi Province.

经费或物资来源：

自筹

Source(s) of funding：

self-financed

研究疾病：

脑卒中后上肢功能障碍

研究疾病代码：

Target disease：

Upper limb dysfunction 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：

治疗新技术临床试验

New Treatment Measure Clinical Study

研究目的：

1) 采用多中心、随机对照的研究方法，分析比较针灸联合iTBS对脑卒中患者上肢运动功能障碍的康复效果、安全性。 2) 探索针灸联合iTBS对脑卒中患者上肢运动功能障碍的可行性和有效性，为临床康复提供新方法。

Objectives of Study：

1) Using the multi-center randomized controlled research method to analyze and compare the rehabilitation efficacy and safety of acupuncture combined with intermittent theta burst stimulation (iTBS) for upper limb motor dysfunction in stroke patients. 2) To explore the feasibility and effectiveness of acupuncture combined with iTBS for upper limb motor dysfunction in stroke patients so as to provide new approaches for clinical rehabilitation.

药物成份或治疗方案详述：

入组患者均为首次发生脑卒中，具有上肢运动功能障碍，病程2周-12个月。本研究覆盖商洛市中心医院、商洛市中医医院、商州区人民医院共3家医院，采用多中心、随机对照的研究方法，遵循盲法及重复等原则。共招募300例受试者。每家医院100例，随机分为3组，分别为：A组（iTBS组）、B组（针灸组）、C组（iTBS联合针灸组），每组33例。干预措施：A组（iTBS组）在常规康复治疗的基础上增加iTBS，B组（针灸组）在常规康复治疗的基础上增加针灸治疗，C组（iTBS、针灸联合组）在常规康复治疗的基础上增加iTBS治疗、针灸治疗。 1)常规康复治疗：3组均给予偏瘫肢体综合训练、物理因子治疗、作业疗法。偏瘫肢体 综合训练：如双手叉握上举运动(双手交叉、双上肢伸肘、肩关节前屈上举)、桥式运动(仰卧位屈髋、屈膝、挺腹运动)、Bobath握手下推滚筒、摩擦板、插木钉等，每次训练时间45min，每日1次，每周训练5天，共治疗20次。物理因子治疗为电子生物反馈治疗，每次20min，每日1次，每周训练5天，共治疗20次。作业疗法每次训练时间45min，每日1次，每周训练5天，共治疗20次。 2）iTBS干预： 应用武汉依瑞德医疗设备新技术有限公司生产的YRD CCY-Ⅰ型磁刺激仪，选用圆型线圈。首先测量患者运动阈值并记录，刺激强度：80%运动阈值(MT)。刺激靶点为患侧M1区；刺激方式：刺激模式为iTBS，600个脉冲，3个50Hz的脉冲为一串，串间隔200ms，刺激2s为一组，组间间隔8s，刺激时间为3min，每日干预1次，5天/周，持续4周，共20次治疗。 3）针灸治疗： 头皮针以《头皮针针刺部位国际标准化方案》为依据，选取顶颞前、后斜线，将两条斜线均分为 5 等分，分别为上 1/5，中 2/5，下 2/5，本课题选取患者功能正常肢体侧的顶颞前、后斜线的中 2/5，治疗患侧上肢功能障碍。体针选取肩髃、肩贞、天井、曲池、尺泽、曲泽、外关、阳池、阳溪、阳谷、合谷等在经筋结聚之处的穴位。每次30min，每日1次，每周训练5天，共4周20次治疗。 疗效评价： 分别于治疗前、治疗2周、治疗4周后，由两名工作经验2年以上并对分组情况不知情的康复治疗师对两组纳入患者进行评定。1)主要结局指标：Wolf运动功能测试(Wolf Motor Function Test, WMFT)。2)次要结局指标：Fugl-Meyer上肢运动功能评定量表（Fugl-Meyer Assessment Upper Extremity Scale，FMA-UE）；上肢动作研究量表(Action Research Arm Test, ARAT)；改良Ashworh评分上肢部分(The Upper Extremity Section of the Modified Ashworth Scale, MASUE)；改良Barthel指数(Modified Barthel Index, MBI)；脑卒中特定生存质量量表(Stroke-specific Quality of Life scale,SS-QOL)。比较两组治疗效果及安全性。

Description for medicine or protocol of treatment in detail：

All the enrolled patients were experiencing their first stroke and had upper limb motor dysfunction, with a disease course ranging from 2 weeks to 12 months. This study covered three hospitals: Shangluo Central Hospital, Shangluo Hospital of Traditional Chinese Medicine, and Shangzhou District People's Hospital. It adopted a multi-center, randomized controlled research method, adhering to principles such as blinding and repetition. A total of 300 subjects were recruited, with 100 cases from each hospital, randomly divided into three groups: Group A (iTBS group), Group B (acupuncture group), and Group C (iTBS combined with acupuncture group), with 33 cases in each group. The intervention measures were as follows: 1) Conventional rehabilitation treatment: All three groups were given comprehensive training for the hemiplegic limb, physical factor therapy, and occupational therapy. Comprehensive training for the hemiplegic limb included exercises such as crossing hands and raising them (crossing hands, extending both upper limbs, and flexing the shoulder joint to raise them), bridge exercise (lying on the back, flexing the hip and knee, and raising the abdomen), Bobath hand-down push roller, friction board, and peg insertion, etc. Each training session lasted 45 minutes, once a day, five days a week, for a total of 20 sessions. Physical factor therapy was electronic biofeedback therapy, lasting 20 minutes each time, once a day, five days a week, for a total of 20 sessions. Occupational therapy lasted 45 minutes each time, once a day, five days a week, for a total of 20 sessions. 2) iTBS intervention: The YRD CCY-I type magnetic stimulator produced by Wuhan Yiruidi Medical Equipment New Technology Co., Ltd. was used, with a circular coil. First, the motor threshold of the patient was measured and recorded. The stimulation intensity was 80% of the motor threshold (MT). The stimulation target was the M1 area on the affected side; the stimulation mode was iTBS, with 600 pulses, three 50Hz pulses as a train, with an interval of 200ms between trains, and a stimulation time of 2 seconds as a group, with an interval of 8 seconds between groups, for a total stimulation time of 3 minutes, once a day, five days a week, for a total of 20 sessions. 3) Acupuncture treatment: Scalp acupuncture was based on the "International Standardized Protocol for Scalp Acupuncture Points", selecting the anterior and posterior oblique lines of the top and temporal regions. Each oblique line was divided into five equal parts, namely the upper 1/5, middle 2/5, and lower 2/5. This study selected the middle 2/5 of the anterior and posterior oblique lines on the side of the patient's normal limb to treat the upper limb dysfunction on the affected side. Body acupuncture selected acupoints such as Jianyu, Jianzhen, Tianjing, Quchi, Shize, Quze, Waiguan, Yangchi, Yangxi, Yanggu, and Hegu, which are located at the convergence of the meridians. Each session lasted 30 minutes, once a day, five days a week, for a total of 20 sessions over four weeks. Efficacy evaluation: Before treatment, after 2 weeks of treatment, and after 4 weeks of treatment, two rehabilitation therapists with more than 2 years of experience and unaware of the group allocation evaluated the included patients. 1) The primary outcome measure was the Wolf Motor Function Test (WMFT). 2) The secondary outcome measures were the Fugl-Meyer Assessment Upper Extremity Scale (FMA-UE), the Action Research Arm Test (ARAT), and the Upper Extremity Section of the Modified Ashworth Scale (MASUE). The Modified Barthel Index (MBI) and the Stroke-specific Quality of Life scale (SS-QOL) were used. The therapeutic effects and safety of the two groups were compared.

纳入标准：

1)脑卒中首次发病且符合WHO脑卒中诊疗指南和2015年发布的“中国急性缺血性脑卒中诊治指南2014”，经头颅CT或MRI影像学扫描加以证实； 2)病程>2周且<12个月； 3)脑损伤后病情稳定； 4)年龄18-85周岁； 5)上肢运动功能障碍； 6)意识清楚、心肺功能良好、生命体征平稳、能很好的配合训练； 7)承诺遵守研究程序，并配合实施全过程研究； 8)承诺研究期间遵守有关生活方式的注意事项； 9)患侧上肢，手Brunnstrom评定在II级以上； 10)愿意签署本研究知情同意书。

Inclusion criteria

1) Having the first onset of stroke and conforming to the WHO Stroke Diagnosis and Treatment Guidelines as well as the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2014" released in 2015 which have been confirmed by cranial CT or MRI imaging scans. 2) The course of the disease being more than 2 weeks and less than 12 months. 3) Having a stable condition after brain injury. 4) Being aged between 18 and 85 years old. 5) Having upper limb motor dysfunction. 6) Having a clear consciousness good cardiopulmonary function stable vital signs and being able to cooperate well with the training. 7) Promising to abide by the research procedures and cooperate with the implementation of the whole research process. 8) Promising to comply with the precautions regarding lifestyle during the research period. 9) Having the Brunnstrom assessment of the affected upper limb and hand at or above grade II. 10) Being willing to sign the informed consent form for this research.

排除标准：

1)伴有意识障碍或认知功能障碍、混合性失语等影响评估与治疗的； 2)肌张力过高，Ashworth分级III级，上肢肌力<2级； 3)合并肝、肾、心脏等重要脏器功能障碍等重大疾病等； 4)有严重的上肢关节疾病等既往史(例如肿瘤、骨折等)； 5)内置心脏起搏器或颅内植入其他金属医疗器械； 6)严重的中风发作； 7)怀孕或哺乳期的妇女； 8)颅骨缺损者； 9)研究者认为存在可能损害受试者或者导致受试者无法满足或执行研究要求的任何状况。

Exclusion criteria：

1) Those accompanied by disorders of consciousness or cognitive dysfunction mixed aphasia etc. that may affect assessment and treatment. 2) Those with excessive muscle tone at Ashworth grade III and upper limb muscle strength less than grade 2. 3) Those with major diseases such as combined dysfunction of important organs like the liver kidneys and heart. 4) Those with a past history of severe upper limb joint diseases (such as tumors fractures etc.). 5) Those with an implanted cardiac pacemaker or other metal medical devices implanted intracranially. 6) Those with severe stroke attacks. 7) Pregnant or lactating women. 8) Those with cranial bone defects. 9) Any condition that in the opinion of the researcher may harm the subjects or cause them to be unable to meet or execute the research requirements.

研究实施时间：

Study execute time：

从From 2025-01-01

至To      2026-12-31

征募观察对象时间：

Recruiting time：

从From 2025-03-01

至To      2025-12-31

干预措施：

Interventions：

组别：

C组（iTBS、针灸联合组）

样本量：

100

Group：

Group C (iTBS and acupuncture combined group)

Sample size：

干预措施：

常规康复治疗（包括偏瘫肢体综合训练、电子生物反馈、作业疗法）、针灸治疗、iTBS

干预措施代码：

Intervention：

Routine rehabilitation treatment (including comprehensive training of hemiplegic limbs, electronic biofeedback, occupational therapy), acupuncture treatment, iTBS

Intervention code：

组别：

A组（iTBS组）

样本量：

100

Group：

Group A (iTBS Group)

Sample size：

干预措施：

常规康复治疗（包括偏瘫肢体综合训练、电子生物反馈、作业疗法）、iTBS

干预措施代码：

Intervention：

Routine rehabilitation therapy (including comprehensive training of hemiplegic limbs, electronic biofeedback, occupational therapy), iTBS

Intervention code：

组别：

B组（针灸组）

样本量：

100

Group：

Group B (acupuncture group)

Sample size：

干预措施：

常规康复治疗（包括偏瘫肢体综合训练、电子生物反馈、作业疗法）、针灸治疗

干预措施代码：

Intervention：

Routine rehabilitation treatment (including comprehensive training of hemiplegic limbs, electronic biofeedback, occupational therapy), acupuncture treatment

Intervention code：

样本总量 Total sample size ： 300

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

陕西省

市(区县)：

商洛市

Country：

China

Province：

Shaanxi Province

City：

Shangluo

单位(医院)：

商州区人民医院

单位级别：

二级

Institution/hospital：

Shangzhou District People's Hospital of Shangluo City.

Level of the institution：

Tertiary B

国家：

中国

省(直辖市)：

陕西省

市(区县)：

商洛市

Country：

China

Province：

Shaanxi Province

City：

Shangluo

单位(医院)：

商洛市中医医院

单位级别：

三甲

Institution/hospital：

Shangluo Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

国家：

中国

省(直辖市)：

陕西省

市(区县)：

商洛市

Country：

China

Province：

Shaanxi Province

City：

Shangluo

单位(医院)：

商洛市中心医院

单位级别：

三甲

Institution/hospital：

Shangluo Central Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

脑卒中特定生存质量量表

指标类型：

次要指标

Outcome：

Stroke-specific Quality of Life scale,SS-QOL

Type：

Secondary indicator

测量时间点：

治疗前、治疗2周、治疗4周后

测量方法：

量表评估

Measure time point of outcome：

Before treatment, 2 weeks after treatment, and 4 weeks after treatment.

Measure method：

Scale assessment

指标中文名：

上肢动作研究量表

指标类型：

次要指标

Outcome：

Action Research Arm Test,ARAT

Type：

Secondary indicator

测量时间点：

治疗前、治疗2周、治疗4周后

测量方法：

量表评估

Measure time point of outcome：

Before treatment, 2 weeks after treatment, and 4 weeks after treatment.

Measure method：

Scale assessment

指标中文名：

改良Barthel指数

指标类型：

次要指标

Outcome：

Modified Barthel Index, MBI

Type：

Secondary indicator

测量时间点：

治疗前、治疗2周、治疗4周后

测量方法：

量表评估

Measure time point of outcome：

Before treatment, 2 weeks after treatment, and 4 weeks after treatment.

Measure method：

Scale assessment

指标中文名：

改良Ashworh评分上肢部分

指标类型：

次要指标

Outcome：

The Upper Extremity Section of the Modified Ashworth Scale, MASUE

Type：

Secondary indicator

测量时间点：

治疗前、治疗2周、治疗4周后

测量方法：

量表评估

Measure time point of outcome：

Before treatment, 2 weeks after treatment, and 4 weeks after treatment.

Measure method：

Scale assessment

指标中文名：

Fugl-Meyer上肢运动功能评定量表

指标类型：

次要指标

Outcome：

Fugl-Meyer Assessment Upper Extremity Scale,FMA-UE

Type：

Secondary indicator

测量时间点：

治疗前、治疗2周、治疗4周后

测量方法：

量表评估

Measure time point of outcome：

Before treatment, 2 weeks after treatment, and 4 weeks after treatment.

Measure method：

Scale assessment

指标中文名：

Wolf运动功能测试

指标类型：

主要指标

Outcome：

Wolf Motor Function Test WMFT

Type：

Primary indicator

测量时间点：

治疗前、治疗2周、治疗4周后

测量方法：

量表评估

Measure time point of outcome：

Before treatment 2 weeks after treatment and 4 weeks after treatment.

Measure method：

Scale assessment

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 

Others

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 85 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）：

本研究采用随机数字表法：将患者依次编号为1,2,3，……。然后从随机数字表中任意一个随机数字开始，向任意方向(上、下、左、右)按序抄下300个随机两位数字。若该数字除以3，余数为0编为A组,余数为1时编为B组，余数为2编为C组。若分配不均时，则继续用随机方法进行调整。数字表参考来源于颜虹，徐勇勇主编，《医学统计学》第3版，人民卫生出版社。

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

In this study, a random number table method was used: patients were sequentially numbered as 1,2,3,... . Then start with any random number in the random number table and copy down 300 random two-digit numbers in order in any direction (up, down, left, right). If the number is divided by 3, the remainder of 0 is classified as group A, the remainder of 1 is classified as group B, and the remainder of 2 is classified as group C. If the distribution is uneven, it will continue to adjust by random method. The reference of digital table is from Yan Hong, Xu Yongyong, Ed., Medical Statistics, 3rd edition, People's Medical Publishing House.

盲法：

本研究采用单盲法，临床测量人员与治疗者分离，贯彻盲法精神。

Blinding：

This study adopted the single-blind method. The clinical measurers were separated from the therapists to implement the spirit of the blinding method.

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）：

研究结束后，通过ResMan(www.medresman.org.cn)方式共享

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

After the end of the study it was shared by ResMan (www.medresman.org.cn).

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：

CRF

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

CRF

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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