ChiCTR2400080158 版本V1.0 版本创建时间2024/01/22 11:36:50 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：

ChiCTR2400080158 

最近更新日期：

Date of Last Refreshed on：

2024-01-22 11:36:42 

注册时间：

Date of Registration：

2024-01-22 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于运动视觉捕捉与肌电分析构建脑卒中偏瘫中医功法新康复技术的临床研究

Public title：

Clinical Study of a Novel Rehabilitation Technique for Post-Stroke Hemiplegia Based on Motion Visual Capture and Electromyography Analysis in Traditional Chinese Medicine Practice.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于运动视觉捕捉与肌电分析构建脑卒中偏瘫中医功法新康复技术的临床研究

Scientific title：

Clinical Study of a Novel Rehabilitation Technique for Post-Stroke Hemiplegia Based on Motion Visual Capture and Electromyography Analysis in Traditional Chinese Medicine Practice.

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：

李治 

研究负责人：

王培 

Applicant：

Zhi Li 

Study leader：

Pei Wang 

申请注册联系人电话：

Applicant telephone：

+86 188 0104 4897

研究负责人电话：

Study leader's telephone：

+86 159 5175 2352

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：

220223789@seu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

wangpei0717@126.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：

南京市鼓楼区新模范马路3号

研究负责人通讯地址：

南京市鼓楼区新模范马路3号

Applicant address：

3 New Model Road, Gulou District, Nanjing

Study leader's address：

3 New Model Road, Gulou District, Nanjing

申请注册联系人邮政编码：

Applicant postcode：

210003

研究负责人邮政编码：

Study leader's postcode：

210003

申请人所在单位：

东南大学附属中大医院

Applicant's institution：

Zhongda Hospital of Southeast University

研究负责人所在单位：

东南大学附属中大医院

Affiliation of the Leader：

Zhongda Hospital of Southeast University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2023ZDSYLL378-P01

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：

东南大学附属中大医院临床研究伦理委员会

Name of the ethic committee：

Clinical Research Ethics Committee of Zhongda Hospital, Southeast University

伦理委员会批准日期：

Date of approved by ethic committee：

2023-11-06 00:00:00

伦理委员会联系人：

王慧萍

Contact Name of the ethic committee：

wang huiping

伦理委员会联系地址：

南京市鼓楼区丁家桥87号

Contact Address of the ethic committee：

No. 87, Dingjiaqiao, Gulou District, Nanjing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 25 8327 2015

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：

东南大学附属中大医院

Primary sponsor：

Zhongda Hospital of Southeast University

研究实施负责（组长）单位地址：

南京市鼓楼区新模范马路3号

Primary sponsor's address：

3 New Model Road, Gulou District, Nanjing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

Country：

China

Province：

Jiangsu province

City：

单位(医院)：

东南大学附属中大医院

具体地址：

南京市鼓楼区新模范马路3号

Institution
hospital：

Zhongda Hospital of Southeast University

Address：

3 New Model Road, Gulou District, Nanjing

经费或物资来源：

课题经费

Source(s) of funding：

subject funding

Target disease：

stroke

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：

本研究旨在利用计算机视觉捕捉和可穿戴肌电分析等现代技术，对24式太极拳生物力学特征和不同肌群兴奋激活状态进行分析，获得太极拳运动中肢体协同关系与运动特征规律，并在前期已明确脑卒中后运动障碍特征规律的基础上，结合脑卒中后经典的Brunnstrom运动功能分期特点及现代神经发育疗法，设计基于现代康复理论优化的、针对性强的太极拳优化方案，进行临床验证和推广应用。为推动中国传统中医功法在康复领域的应用提供科学依据，为中西医结合康复技术的发展和推广应用探索新的路径和模式。  

Objectives of Study：

This study aims to utilize modern technologies such as computer vision motion capture and wearable electromyography analysis to analyze the biomechanical characteristics and activation states of different muscle groups during the practice of 24-style Tai Chi. The goal is to uncover the coordination patterns and motion characteristics of the limbs during Tai Chi exercises. Building upon the established understanding of post-stroke motor impairments, the study will integrate the classic Brunnstrom stages of motor recovery and modern neurodevelopmental therapy. Based on modern rehabilitation theories, a targeted and optimized Tai Chi rehabilitation program will be designed, clinically validated, and further promoted for application. The research aims to provide a scientific basis for the application of traditional Chinese medicine practices in the field of rehabilitation, and to explore new paths and models for the development and widespread application of integrated rehabilitation technologies combining traditional Chinese medicine practices with Western rehabilitation techniques.

药物成份或治疗方案详述：

无 

Description for medicine or protocol of treatment in detail：

None 

纳入标准：

试验一：①具有1年以上太极拳练习经验；②健康状况良好，在过去6个月内没有下肢及关节损伤史；③同意参加本次试验并签署知情同意书；④年龄18-70岁； 试验二：①计算机断层扫描(computed tomography, CT)和/或MRI确诊为脑梗死患者；②初次、单侧发病或虽既往有发作但未遗留有神经功能障碍；③生命体征稳定；④年龄18～70岁；⑤病程2周-12周；⑥偏侧瘫痪，患侧下肢肌力达3级或3级以上；⑦入选者本人或家属签署知情同意书；⑧改良Rankin量表 (modified Rankin Scale, MRS) 评分≤3。

Inclusion criteria

Experiment 1: ① Have more than 1 year of experience in practicing Tai Chi; ② Good health condition, with no history of lower limb or joint injuries in the past 6 months; ③ Agree to participate in this experiment and sign an informed consent form; ④ Age range from 18 to 70 years old; Experiment 2: ① Computed tomography (CT) and/or MRI confirmed as a patient with cerebral infarction; ② First time, unilateral onset, or although there have been previous episodes but no residual neurological dysfunction; ③ Stable vital signs; ④ Age range from 18 to 70 years old; ⑤ The course of the disease is 2-12 weeks; ⑥ Unilateral paralysis, with lower limb muscle strength of level 3 or above on the affected side; ⑦ The selected individual or their family members sign an informed consent form; ⑧ The Modified Rankin Scale (MRS) score is ≤ 3.

排除标准：

试验一：①临床影像检查提示膝骨性关节炎、膝关节有骨折、脱位、结核、肿瘤、感染等；②有关节骨折、膝关节手术史等其他可能影响下肢运动功能者；③身体结构明显异常者(如扁平足、高弓足、X型腿等)；④其他原因不能配合评估及检测者。 试验二：①有癫痫病史、一级亲属中有特发性癫痫病史及使用致痫药物；②严重认知及交流障碍而不能配合评估及治疗；③后循环脑梗塞；戴有起搏器、颅内有金属植入物；④有严重颈椎病变包括严重颈椎管狭窄、颈椎不稳定；⑤颈内动脉完全闭塞；⑥颅骨缺陷；⑦妊娠期妇女等。

Exclusion criteria：

Experiment 1: ① Clinical imaging examination indicates knee osteoarthritis, knee joint fractures, dislocations, tuberculosis, tumors, infections, etc.; ② Individuals with a history of joint fractures, knee surgery, or other factors that may affect lower limb motor function; ③ Individuals with obvious abnormalities in body structure (such as flat feet, high arched feet, X-shaped legs, etc.); ④ Unable to cooperate with the evaluation and testing personnel for other reasons. Experiment 2: ① Having a history of epilepsy, having a history of idiopathic epilepsy among first-degree relatives, and using antiepileptic drugs; ② Serious cognitive and communication barriers that prevent cooperation in assessment and treatment; ③ Posterior circulation cerebral infarction; Wearing a pacemaker and having metal implants in the skull; ④ Severe cervical spondylosis, including severe cervical canal stenosis and cervical instability; ⑤ Complete occlusion of the internal carotid artery; ⑥ Skull defect; ⑦ Pregnant women, etc.

研究实施时间：

Study execute time：

从 From 2023-07-01 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-02-01 00:00:00 至 To 2026-06-30 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

30

Group：

Tai Chi group

Sample size：

干预措施：

干预组：进行改良24式太极拳运动训练（30min）与常规康复训练（30min），每周3次，共12周。在整个干预期间，由一名熟悉改良太极拳的人员和一名太极拳专业老师共同教授参与者正确的改良太极拳运动。每节课包括20分钟的热身时间，然后连续训练30分钟。教练可以根据患者的个人情况调整训练时间的长短，并进行适当分配。对于连续完成训练有困难的人，将允许其间歇性完成。但每次训练必须持续至少15分钟。所有病人在训练后有5分钟的休息时间。一名监督员将负责训练点的管理，以保证改良太极拳的训练质量。参与者被指示以每周 3 天的训练频率在家中进行相同的练习，直至12周结束。

干预措施代码：

 1

Intervention：

Intervention group: underwent modified 24 style Tai Chi exercise training (30 minutes) and conventional rehabilitation training (30 minutes), three times a week, for a total of 12 weeks. Throughout the intervention period, a person familiar with improving Tai Chi and a professional Tai Chi teacher jointly taught participants the correct exercise of improving Tai Chi. Each class includes 20 minutes of warm-up time, followed by continuous training for 30 minutes. Coaches can adjust the length of training time based on the individual situation of patients and make appropriate allocations. For those who have difficulty completing training continuously, intermittent completion will be allowed. But each training must last at least 15 minutes. All patients have a 5-minute rest time after training. A supervisor will be responsible for the management of training points to ensure the quality of improved Tai Chi training. Participants were instructed to practice the same exercises at home at a frequency of 3 days per week until the end of 12 weeks.

Intervention code：

组别：

对照组

样本量：

30

Group：

control group

Sample size：

干预措施：

对照组接受常规康复计划，包括四肢肌肉和关节的主动活动、本体感觉神经肌肉促进、肌肉阻力训练、拉伸训练、坐站训练和步行。对照组需要每周进行 3 次每次60min的康复训练，参与者被指示以每周 3 天的训练频率在家中进行相同的练习，直至12周结束。

干预措施代码：

 2

Intervention：

The control group received a routine rehabilitation plan, including active movement of limb muscles and joints, proprioceptive neuromuscular promotion, muscle resistance training, stretching training, standing training, and walking. The control group is required to undergo 60 minutes of rehabilitation training three times a week, and participants are instructed to perform the same exercise at home at a frequency of three days per week until the end of 12 weeks.

Intervention code：

组别：

试验一太极拳生物力学研究受试者

样本量：

15

Group：

Experiment 1: Biomechanical Study of Tai Chi Subject

Sample size：

干预措施：

通过运动学分析手段，如三维运动捕捉系统、表面肌电仪器等，得出太极拳运动的运动学及动力学参数。受试者进行24式太极拳的同时，在其身体正前方、斜45°方向分别放置一个RGB-D深度视觉相机。通过机器视觉技术采集受试者的骨架点位，使用基于卷积神经网络的识别模型，收集受试者上肢与下肢的关节活动度、各方向的运动力矩等信息，并通过将无创可穿戴肌电环放置在上臂与前臂、大腿与小腿固定位置皮肤表面，在受试者进行太极拳运动的同时，记录皮肤表面因肌肉收缩而产生的微弱电位差。

干预措施代码：

 3

Intervention：

By using kinematic analysis methods such as 3D motion capture systems and surface electromyography instruments, the kinematic and dynamic parameters of Tai Chi movements are obtained. During the 24 style Tai Chi exercise, subjects were placed with RGB-D depth vision cameras in front of their bodies and at a 45 ° angle. By using machine vision technology to collect the skeletal points of the subjects, a recognition model based on convolutional neural networks is used to collect information on the joint activity of the upper and lower limbs, as well as the motion torque in all directions. Non invasive wearable electromyography rings are placed on the skin surface of the fixed positions of the upper arm and forearm, thigh and calf. While the subjects perform Tai Chi exercises, the weak potential difference on the skin surface caused by muscle contraction is recorded.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏省 

市(区县)：

  

Country：

China 

Province：

Jiangsu province 

City：

 

单位(医院)：

东南大学附属中大医院 

单位级别：

三甲医院 

Institution
hospital：

zhongda hospital of southeast university

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 Nanjing 

市(区县)：

  

Country：

China 

Province：

Jiangsu province 

City：

 

单位(医院)：

南京体育学院 

单位级别：

大学 

Institution
hospital：

Nanjing sport institute

Level of the institution：

university

测量指标：

Outcomes：

指标中文名：

表面肌电图动力学参数，如均方根振幅、积分肌电值、平均肌电值

指标类型：

主要指标

Outcome：

Kinetic parameters of surface electromyography，eg.RMS, iEMG, aEMG

Type：

Primary indicator

测量时间点：

干预之前与干预之后

测量方法：

表面肌电机器测量

Measure time point of outcome：

Before and after intervention

Measure method：

Surface electromyography machine measurement

指标中文名：

动态视觉捕捉运动学参数，如重心移动轨迹、关节活动范围等

指标类型：

主要指标

Outcome：

Kinematic parameters of dynamic visual capture，eg. COM, ROM

Type：

Primary indicator

测量时间点：

干预之前与干预之后

测量方法：

相机测量

Measure time point of outcome：

Before and after intervention

Measure method：

Camera measurement

指标中文名：

脑卒中ICF核心组合评估

指标类型：

次要指标

Outcome：

Evaluation of ICF Core combination in Stroke

Type：

Secondary indicator

测量时间点：

干预之前与干预之后

测量方法：

量表测量

Measure time point of outcome：

Before and after intervention

Measure method：

Scale measurement

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：

干预之前与干预之后

测量方法：

量表测量

Measure time point of outcome：

Before and after intervention

Measure method：

Scale measurement

指标中文名：

Fugl-Meyer上肢功能评分

指标类型：

次要指标

Outcome：

Fugl-Meyer assessment for upper extremity?(FMA-UE)

Type：

Secondary indicator

测量时间点：

干预之前与干预之后

测量方法：

量表测量

Measure time point of outcome：

Before and after intervention

Measure method：

Scale measurement

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

None

Tissue：

none

人体标本去向

 使用后销毁  

说明

无

Fate of sample：

Destruction after use  

Note：

none

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 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）：

试验一为个人联系招募太极拳练习者，不涉及随机化方法。 试验二在招募研究参与者之前，我们将建立一个随机化分组表，表中的编号将与实验参与者一一对应。符合标准的参加者将被（按1:1的基础）随机分配至实验组（n=30）或对照组（n=30）。随机分配的过程将由独立于研究团队的第三方实施，以确保随机性的可靠性。

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

Experiment 1 recruits Taijiquan practitioners for personal contact and does not involve a randomized method. In experiment 2, before recruiting research participants, we will establish a randomized grouping table, and the number in the table will correspond to the experimental participants one by one. Participants who meet the criteria will be randomly assigned (on a 1:1 basis) to the experimental group (n =30) or the control group (n =30). The random allocation process will be implemented by a third party independent of the research team to ensure the reliability of randomness.

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：

试验一不涉及盲法。 试验二由于研究的干预性质，在实验中不可能对教授太极拳的治疗师及参与者使用盲法，但该治疗师将不会参与评估环节。另外，参与评估与统计分析的研究人员将不参与参与者的筛选和分配。所有结果数据将由进行随机分组的人员(独立于研究小组)使用唯一编号和小组代码(第1组和第2组)收集和输入。

Blinding：

The blind method was not involved in experiment 1. In experiment 2, because of the intervention nature of the study, it is impossible to use blind method to the therapists and participants who teach Taijiquan, but the therapist will not participate in the evaluation. In addition, researchers involved in evaluation and statistical analysis will not participate in the screening and distribution of participants. All result data will be collected and entered by randomly grouped personnel (independent of the research team) using unique numbers and team codes (groups 1 and 2).

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

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）：

中国临床试验注册中心，http://www.chictr.org.on

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

Chinese Clinical Trial Registration Center,http://www.chictr.org.on

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：

数据采集与管理将结合病例记录表与电子采集和管理系统进行

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

Data collection and management will be combined with case record forms and electronic collection and management systems

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：

  2024-01-22 11:36:42