ChiCTR2200061376 版本V1.0 版本创建时间2023/03/24 21:08:34 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：

 ChiCTR2200061376 

最近更新日期：

Date of Last Refreshed on：

 2022-06-22 15:14:49 

注册时间：

Date of Registration：

 2022-06-22 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

太极拳改善脑卒中患者上肢运动策略的神经生物力学作用机制研究

Public title：

Study on neurobiomechanical mechanism of Taijiquan in improving upper limb motor strategy in stroke patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于感觉运动-额顶网络与上肢肌肉激活模式的耦合探讨太极拳改善脑卒中后上肢协调功能的机制

Scientific title：

Based on the coupling of sensorimotor - frontal parietal network and upper limb muscle activation mode to explore the mechanism of Taijiquan to improve the coordination function of upper limbs after stroke

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：

谢秋蓉 

研究负责人：

谢秋蓉 

Applicant：

XIE Qiurong 

Study leader：

XIE Qiurong 

申请注册联系人电话：

Applicant telephone：

 15005000559

研究负责人电话：

Study leader's
telephone：

15005000559

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：

 qwfyby@163.com

研究负责人电子邮件：

Study leader's E-mail：

 qwfyby@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 福建中医药大学

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：

福建省福州市闽侯县邱阳路1号福建中医药大学

研究负责人通讯地址：

福建省福州市闽侯县邱阳路1号福建中医药大学

Applicant address：

Fujian University of Traditional Chinese Medicine, No. 1, Qiuyang Road, Minhou County, Fuzhou City, Fujian Province

Study leader's address：

Fujian University of Traditional Chinese Medicine, No. 1, Qiuyang Road, Minhou County, Fuzhou City, Fujian Province

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：

福建中医药大学

Applicant's institution：

Fujian University of Traditional Chinese Medicine

研究负责人所在单位：

福建中医药大学

Affiliation of the Leader：

Fujian 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：

 2021KF-005-03

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：

福建中医药大学附属康复医院伦理委员会

Name of the ethic committee：

Ethics Committee of Rehabilitation Hospital affiliated to Fujian University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-03-04 00:00:00

伦理委员会联系人：

林艳姗

Contact Name of the ethic committee：

谢秋蓉

伦理委员会联系地址：

福建省福州市闽侯县邱阳路1号福建中医药大学

Contact Address of the ethic committee：

Fujian University of Traditional Chinese Medicine, No. 1, Qiuyang Road, Minhou County, Fuzhou City, Fujian Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 15005000559

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 qwfyby@163.com

研究实施负责（组长）单位：

福建中医药大学

Primary sponsor：

Fujian University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

福建省福州市闽侯县邱阳路1号福建中医药大学

Primary sponsor's address：

Fujian University of Traditional Chinese Medicine, No. 1, Qiuyang Road, Minhou County, Fuzhou City, Fujian 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)：

福建

市(区县)：

福州

Country：

China

Province：

Fujian

City：

Fuzhou

单位(医院)：

福建中医药大学

具体地址：

福建省福州市闽侯县邱阳路1号福建中医药大学

Institution
hospital：

Fujian University of Traditional Chinese Medicine

Address：

Fujian University of Traditional Chinese Medicine,1 Qiuyang Road, Minhou County, Fuzhou, Fujian

经费或物资来源：

福建中医药大学

Source(s) of funding：

Fujian University of Traditional Chinese Medicine

研究疾病：

脑卒中  

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

（1）明确太极拳改善卒中后上肢功能的临床效果及运动学特征改变。 （2）应用神经影像学和神经生理学相结合的多模态方法观察太极拳对卒中患者感觉运动-额顶皮质和上肢肌肉激活模式耦合的影响，分析其与上肢功能变化的相关性，阐明太极拳疗法促进卒中患者上肢功能改善的神经网络和肌肉网络重组机制。  

Objectives of Study：

(1) To clarify the clinical effect and kinematic characteristics of Taijiquan in improving upper limb function after stroke. (2) The multimodal method combining neuroimaging and neurophysiology was used to observe the effect of Taijiquan on the coupling of sensory motor frontal parietal cortex and upper limb muscle activation mode in stroke patients, analyze its correlation with the changes of upper limb function, and clarify the neural network and muscle network reorganization mechanism of Taijiquan therapy in promoting the improvement of upper limb function in stroke patients.

药物成份或治疗方案详述：

（1）对照组 该组实施常规内科治疗、健康教育和康复训练。 ①常规内科治疗 依据2015年中华医学会神经病学分会脑血管病学组制定的《中国缺血性卒中和短暂性脑缺血发作二级预防指南2014》对入组的受试者实施常规内科治疗，具体包括病因的处理、血压管理、抗血小板、抗凝治疗、合并心脏病的基础治疗、高半膀氨酸血症的治疗、血糖、血脂的管理等。 ②健康教育 依据《走出卒中病人康复误区》(人民卫生出版社，2008年，陈立典主编）对受试者进行健康教育，包括i了解卒中的严重危害，引起足够重视，自觉采取积极防范措施；ii了解卒中发生的主要危险因子、诱发因素、如何进行二级预防；iii了解卒中的应对及康复。 ③康复训练 治疗师依据《常用康复治疗技术操作规范（2012年版）》（中国康复医学会组织专家撰写）对受试者进行康复训练。 （2）治疗组 治疗组在常规内科治疗、健康教育、康复训练的基础上实施太极拳训练。 ①基础治疗和康复训练同对照组。 ②太极拳训练方案 进行太极拳训练，由具有5年以上教练资质的太极拳教练带领练习。太极训练遵循渐进的、从部分到整体的、由易到难的过程。 教师根据每个参与者的能力选择合适的太极形式。在为每个参与者调整太极训练时，使用了两个关键原则：（1）参与者应该能够在放松的同时练习太极动作；（2）应该有尽可能多的全身协调。参与者尽可能放松肌肉和关节，并专注于帮助放松的运动，以最小的感知用力来完成这些动作。动作练习缓慢、重复，必要时甚至分段进行。 太极招式选取起势、野马分鬃、搂膝拗步、倒卷肱、左揽雀尾、右揽雀尾、云手、收势，共八个招式（根据文献[11, 12]选择）。标准动作参考国家体育总局（http://www.sport .gov .cn/）推广的24个简化版太极拳。在实际训练过程中，不会强调姿势套路的准确性和连贯性。同时根据患者的实际运动能力，适当降低达到姿势标准的难度。 干预时间 每次集中练习60分钟，包括5分钟热身，50分钟太极拳训练和5分钟整理。每周练习5次，持续4周。 所有研究对象在干预开始后至4周干预结束每天记录当天活动情况及持续时间（归类为静态作业、低等强度活动、中等强度活动和高等强度活动），饮食、服用药物、就诊与否等情况。 

Description for medicine or protocol of treatment in detail：

(1) Control group The group implemented routine medical treatment, health education and rehabilitation training. ① Routine medical treatment According to the guidelines for secondary prevention of ischemic stroke and transient ischemic attack in China 2014 formulated by the cerebrovascular disease group of Neurology branch of Chinese Medical Association in 2015, the subjects were treated with routine medical treatment, including etiological treatment, blood pressure management, antiplatelet, anticoagulant treatment, basic treatment of combined heart disease, treatment of hyperglycemia, blood glucose and blood lipid management. ② Health education According to "walking out of the misunderstanding of rehabilitation of stroke patients" (people's Health Publishing House, 2008, edited by Chen Lidian), health education was carried out for subjects, including I understanding the serious harm of stroke, attracting enough attention and consciously taking active preventive measures; II understand the main risk factors and inducing factors of stroke and how to carry out secondary prevention; III understand the coping and rehabilitation of stroke. ③ Rehabilitation training The therapist conducted rehabilitation training for the subjects according to the technical operation specifications for common rehabilitation treatment (2012 Edition) (written by experts organized by China Rehabilitation Medical Association). (2) Treatment group The treatment group carried out Taijiquan training on the basis of routine medical treatment, health education and rehabilitation training. ① Basic treatment and rehabilitation training were the same as those in the control group. ② Taijiquan training program Taijiquan training shall be conducted under the leadership of Taijiquan coaches with more than 5 years of coaching qualification. Tai Chi training follows a gradual process, from part to whole, from easy to difficult. The teacher chooses the appropriate form of Tai Chi according to the ability of each participant. When adjusting Tai Chi training for each participant, two key principles are used: (1) participants should be able to practice Tai Chi while relaxing; (2) There should be as much overall coordination as possible. Participants relaxed their muscles and joints as much as possible and focused on the movements that helped them relax, completing these movements with minimal perceived effort. The movement practice is slow and repeated, and even carried out in sections when necessary. The Taiji moves include eight moves: rising posture, wild horse dividing mane, embracing knee and bending step, rolling back arm, left holding bird tail, right holding bird tail, cloud hand and ending posture (selected according to literature [11,12]). Refer to the State Sports Administration for standard movements（ http://www.sport .gov . Cn /) promoted 24 simplified versions of Taijiquan. In the actual training process, the accuracy and consistency of posture routine will not be emphasized. At the same time, according to the patient's actual exercise ability, appropriately reduce the difficulty of reaching the posture standard. The intervention time is 60 minutes each time, including 5 minutes of warm-up, 50 minutes of Taijiquan training and 5 minutes of finishing. Practice five times a week for four weeks. From the beginning of the intervention to the end of the 4-week intervention, all subjects recorded the activities and duration of the day (classified as static work, low-intensity activities, medium-intensity activities and high-intensity activities), diet, taking drugs, whether to see a doctor or not, etc. 

纳入标准：

①符合1995年全国第四届脑血管病学术会议通过的《各类脑血管疾病诊断要点》中“卒中”的诊断标准，并经头颅CT或MRI检查证实；
②首次卒中，2周≤病程≤6个月；
③18岁≤年龄≤70岁；
④血压稳定在160\100mmHg以下；
⑤简易精神状态量表检查评分：文盲＞17分，小学＞20分，中学以上＞24分；
⑥患侧上肢Brunstrom分期IV期及以上；
⑦站立平衡≥2级，独立站立5分钟以上，独立行走6米以上；
⑧愿意签署知情同意书，能理解、接受康复指导并实施。

Inclusion criteria

① It meets the diagnostic criteria of "stroke" in the diagnostic points of various cerebrovascular diseases adopted by the fourth national cerebrovascular disease academic conference in 1995, and is confirmed by cranial CT or MRI;

② First stroke, 2 weeks ≤ course ≤ 6 months;

③ 18 ≤ 70 years old;

④ Blood pressure is stable below 160 \ 100mmhg;

⑤ The scores of Mini Mental State Scale: illiterate > 17 points, primary school > 20 points, Middle School > 24 points;

⑥ Brunstrom stage IV and above of the affected upper limb;

⑦ Standing balance ≥ Level 2, stand independently for more than 5 minutes and walk independently for more than 6 meters;

⑧ Willing to sign informed consent form, able to understand, accept rehabilitation guidance and implement it.

排除标准：

①由其他脑病如脑肿瘤、脑外伤、脑寄生虫病等引起的上肢运动功能障碍者；
②有如下疾病影响训练者：严重的下肢关节疾病、关节炎和关节损伤，脊髓型颈椎病，腰骶椎管狭窄，下肢神经病变；
③有卒中严重并发症如严重的肺部感染、肩手综合征、下肢静脉栓塞等的患者；
④存在严重的心脏疾病，心、肝、肾功能衰竭，恶性肿瘤、消化道出血者；
⑤简易精神状态检查量表评分：文盲≤17分，小学≤20分，中学以上≤24分；
⑥存在严重的视力障碍无法完成训练者；
⑦感觉性失语（无法理解指导语）者；
⑧6个月内参加过太极训练的患者；
⑨近红外功能成像和脑电图检查的禁忌症，例如，皮肤感染，头皮伤口，皮炎，电极下的金属植入物等；
⑩患有影响表面肌电图检查的四肢皮肤或肌肉病变的患者；
?其他原因不能配合或不适宜参与本研究的检查、评估和治疗者，如疼痛难忍、精神状态异常、活动能力受限等；
?参与其他临床研究的患者。

Exclusion criteria：

① Upper limb motor dysfunction caused by other brain diseases such as brain tumor, brain trauma and brain parasitic disease;

② Those who have the following diseases affecting the training: serious lower limb joint diseases, arthritis and joint injury, cervical spondylotic myelopathy, lumbosacral spinal canal stenosis, lower limb neuropathy;

③ Patients with severe complications of stroke, such as severe pulmonary infection, shoulder hand syndrome, lower extremity venous embolism, etc;

④ Those with serious heart disease, heart, liver and kidney failure, malignant tumor and gastrointestinal bleeding;

⑤ Scores of the mini mental state examination scale: illiterate ≤ 17 points, primary school ≤ 20 points, middle school or above ≤ 24 points;

⑥ Those who have serious visual impairment and cannot complete the training;

⑦ Sensory aphasia (unable to understand instructions);

⑧ Patients who have participated in Tai Chi training within 6 months;

⑨ Contraindications of near infrared functional imaging and EEG, such as skin infection, scalp wound, dermatitis, metal implant under electrode, etc;

⑩ Patients with skin or muscle lesions of limbs affecting surface electromyography;

? Those who cannot cooperate or are not suitable to participate in the examination, evaluation and treatment of this study for other reasons, such as unbearable pain, abnormal mental state, limited activity, etc;

? Patients participating in other clinical studies.

研究实施时间：

Study execute time：

从 From 2022-03-05 00:00:00至 To 2023-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-03-05 00:00:00 至 To 2023-12-31 00:00:00

干预措施：

Interventions：

组别：

治疗组

样本量：

 42

Group：

Treatment group

Sample size：

干预措施：

常规内科治疗、健康教育、康复训练、太极拳训练

干预措施代码：

Intervention：

Routine medical treatment, health education, rehabilitation training, Taijiquan training

Intervention code：

组别：

对照组

样本量：

 42

Group：

control group

Sample size：

干预措施：

常规内科治疗、健康教育和康复训练

干预措施代码：

Intervention：

Routine medical treatment, health education and rehabilitation training

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 福建 

市(区县)：

 福州 

Country：

China

Province：

Fujian

City：

Fuzhou

单位(医院)：

 福建中医药大学附属康复医院 

单位级别：

 三级甲等 

Institution
hospital：

Rehabilitation hospital affiliated to Fujian University of traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

皮质-皮质和皮质-肌肉功能连接

指标类型：

主要指标

Outcome：

Cortical-cortical and cortical-muscular functional connections

Type：

Primary indicator

测量时间点：

干预前1周和干预4周后

测量方法：

功能性近红外脑功能成像、脑电图和表面肌电图

Measure time point of outcome：

1 week before intervention and 4 weeks after intervention

Measure method：

Functional near infrared brain functional imaging, EEG and sEMG

指标中文名：

Fugl-Meyer 上肢评分

指标类型：

主要指标

Outcome：

Fugl-Meyer upper limb score

Type：

Primary indicator

测量时间点：

干预前1周和干预4周后

测量方法：

Fugl-Meyer上肢量表

Measure time point of outcome：

1 week before intervention and 4 weeks after intervention

Measure method：

Fugl Meyer upper limb scale

指标中文名：

上肢运动学参数

指标类型：

主要指标

Outcome：

Upper limb kinematics parameters

Type：

Primary indicator

测量时间点：

干预前1周和干预4周后

测量方法：

无标记感应技术（Azure Kinect）

Measure time point of outcome：

1 week before intervention and 4 weeks after intervention

Measure method：

Unmarked sensing technology (azure Kinect)

指标中文名：

Wolf 运动功能评价量表

指标类型：

主要指标

Outcome：

Wolf motor function test ，WMFT

Type：

Primary indicator

测量时间点：

干预前1周和干预4周后

测量方法：

Wolf 运动功能评价量表

Measure time point of outcome：

1 week before intervention and 4 weeks after intervention

Measure method：

Wolf motor function test

指标中文名：

脑卒中影响量表

指标类型：

次要指标

Outcome：

Stroke Impact Scale

Type：

Secondary indicator

测量时间点：

干预前1周和干预4周后

测量方法：

脑卒中影响量表

Measure time point of outcome：

1 week before intervention and 4 weeks after intervention

Measure method：

Stroke Impact Scale

采集人体标本：

Collecting sample(s)
from participants：

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 18 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）：

本次研究受试者随机分组序列由本校循证医学中心统计工作人员采用SAS9.1统计软件PROC PLAN程序产生，并应用不透光、密闭封信法隐藏随机分组序列。将合格对象按纳入的顺序编号以1:1的比例随机分配进入太极拳组和对照组。预先设定产生的随机数字范围为A、B两组，根据随机数字范围将受试者分配至A组或B组，运行SAS统计软件PROC PLAN程序生成随机数字表，将程序产生的随机分组结果打印出来，制订编码。参与随机分配序列产生与保管的人员不参与招募活动，由课题管理者通过电话告知合格参与者分配结果，随机序列由课题组专人负责管理。

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

The random grouping sequence of subjects in this study was adopted by the statistical staff of evidence-based medicine center of our university 1 the statistical software proc plan program is generated, and the opaque and closed letter sealing method is used to hide the random grouping sequence. The qualifi

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：

本研究对评估者和统计者设盲。由不参与干预、评估、统计过程的研究人员保管盲底。盲底由两个盲代码组成，第一个盲代码由字母A或B组成，第二个盲代码描述A或B的真正意义（即说明A或B分别代表治疗组或对照组）。试验结束后，按研究对象编码将数据录入数据库，数据核对无误后，关闭数据库。进行第一次揭盲，由随机序列保管者将受试者的分组代码A或B交给统计分析者，第二次揭盲是在完成数据分析后，由随机序列保管者公布A或B代表治疗组或对照组。

Blinding：

This study blinded evaluators and statisticians. The blind record shall be kept by researchers who do not participate in the intervention, evaluation and statistical process. The blind base consists of two blind codes. The first blind code consists of the letter A or B, and the second blind code describes the true meaning of a or B (that is, a or B represents the treatment group or control group respectively). After the experiment, input the data into the database according to the research object code, and close the database after checking the data. For the first Unblinding, the random sequence keeper will give the grouping code a or B of the subjects to the statistical analyst. For the second Unblinding, after completing the data analysis, the random sequence keeper will announce that a or B represents the treatment group or control group.

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）：

与项目负责人联系后共享数据

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

Share data after contacting the project leader

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：

所有数据均记录在病例记录表和原始记录表中

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

All data are recorded in the case record table and the original record table

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：

  2022-06-22 15:14:49