中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600125740
最近更新日期： Date of Last Refreshed on：	2026-05-29 17:51:15
注册时间： Date of Registration：	2026-05-29 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	经颅直流电刺激对高水平空手道运动员前手拳动作速度的影响
Public title：	The effect of transcranial direct current stimulation on the speed of the front-hand punch movement in excellent karate athletes
注册题目简写：
English Acronym：
研究课题的正式科学名称：	经颅直流电刺激对高水平空手道运动员前手拳动作速度的影响
Scientific title：	The effect of transcranial direct current stimulation on the speed of the front-hand punch movement in excellent karate athletes
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：	陈林果	研究负责人：	陈林果
Applicant：	Linguo Chen	Study leader：	Linguo Chen
申请注册联系人电话： Applicant telephone：	+86 187 7310 3102	研究负责人电话： Study leader's telephone：	+86 187 7310 3102
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：	chenlinguo777@163.com	研究负责人电子邮件： Study leader's E-mail：	chenlinguo777@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：	北京市海淀区信息路48号	研究负责人通讯地址：	北京市海淀区信息路48号
Applicant address：	No. 48, Xinfupu Road, Haidian District, Beijing	Study leader's address：	No. 48, Xinfupu Road, Haidian District, Beijing
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：	北京体育大学
Applicant's institution：	Beijing Sport University
研究负责人所在单位：	北京体育大学
Affiliation of the Leader：	Beijing Sport University

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：	2026222H	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：	北京体育大学运动科学实验伦理委员会
Name of the ethic committee：	Sports Science Experiment Ethics Committee of Beijing Sport University
伦理委员会批准日期： Date of approved by ethic committee：	2026-05-15 00:00:00
伦理委员会联系人：	梅涛
Contact Name of the ethic committee：	Mei Tao
伦理委员会联系地址：	北京市海淀区信息路48号
Contact Address of the ethic committee：	No. 48, Xinfupu Road, Haidian District, Beijing
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 10 6298 9306	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：

北京体育大学

Primary sponsor：

Beijing Sport University

研究实施负责（组长）单位地址：

北京市海淀区信息路48号

Primary sponsor's address：

No. 48, Xinfupu Road, Haidian District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	beijing	City：
单位(医院)：	北京体育大学	具体地址：	北京市海淀区信息路48号
Institution hospital：	Beijing Sport University	Address：	No. 48, Xinfupu Road, Haidian District, Beijing

经费或物资来源：

自费

Source(s) of funding：

Self-funded

研究疾病：

无

Target disease：

NA

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：

横断面

Study design：

Cross-sectional

研究目的：

本研究旨在以空手道运动员为实验对象，采用经颅直流电刺激（tDCS）靶向干预初级运动皮层（M1区），通过科学设计刺激方案，探究tDCS干预对高水平空手道运动员前手拳动作速度的影响，明确该tDCS提升前手拳动作速度的有效性，为优化前手拳速度训练方案提供实证依据。

Objectives of Study：

This study aims to use karate athletes as the experimental subjects, and adopt transcranial direct current stimulation (tDCS) to target the primary motor cortex (M1 area). Through scientifically designed stimulation schemes, it explores the effect of tDCS intervention on the speed of the front-hand punch movements of high-level karate athletes, clarifies the effectiveness of this tDCS in enhancing the speed of the front-hand punch, and provides empirical evidence for optimizing the training scheme of front-hand punch speed.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1.All participants had a physical activity level of level one, and had participated in strength training and karate-specific training at least in the past year;
2.Participants had no history of brain injury, neurological diseases, cardiovascular diseases, no metal implants, scalp skin allergies, etc., which were contraindications for tDCS stimulation;
3.Participants had no muscle or bone injuries within the six months prior to the study. 
4.There was no vigorous activity, smoking, drinking, or caffeine intake within 48 hours before data collection; 
5.The Edinburgh Handedness Inventory (EHI) was used to assess the handedness of the participants, and right-handed athletes (with a handedness index of +60 or higher) were selected to ensure consistency between the dominant hand for the punch and the stimulation target (the contralateral M1 area);
6.Participants were informed of the nature of the study and signed an informed consent form. All operations were in accordance with the Helsinki Declaration and were approved by the Ethics Committee of Beijing Sport University.

排除标准：

1.存在tDCS刺激相关禁忌证或实验过程中出现明显不适无法坚持者； 2.实验过程中动作不规范、数据采集无效且无法补测者 3.因个人原因中途退出研究或违反实验规定者； 4.爱丁堡利手调查问卷判定为左利手或混合利手者。

Exclusion criteria：

1. Participants with contraindications to tDCS stimulation, or those who experience significant discomfort during the experiment and are unable to continue; 2. Participants whose movements during the experiment were non-standard, resulting in invalid data collection that cannot be rectified; 3. Participants who withdraw from the study midway for personal reasons or who breach the experimental protocols; 4. Participants identified as left-handed or ambidextrous according to the Edinburgh Handedness Questionnaire.

研究实施时间：

Study execute time：

从 From 2026-05-31 00:00:00至 To 2026-10-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-05-31 00:00:00 至 To 2026-06-30 00:00:00

干预措施：

Interventions：

组别：	真刺激组	样本量：	10
Group：	The Thrill Seekers	Sample size：	10
干预措施：	本研究中的干预措施为：对高水平空手道运动员施加阳极经颅直流电刺激（a-tDCS），靶向刺激前手拳主导手对侧初级运动皮层（M1区，右利手运动员选取C3位点），电流强度2 mA，刺激时长20分钟（含30秒淡入与淡出），使用5 cm×7 cm海绵电极（阳极置于M1区，阴极置于同侧眶上区）；	干预措施代码：
Intervention：	The intervention measures in this study were as follows: High-level karate athletes were subjected to anodal transcranial direct current stimulation (a-tDCS), targeting the contralateral primary motor cortex (M1 area, for right-handed athletes, the C3 position was selected). The current intensity was 2 mA, and the stimulation duration was 20 minutes (including 30 seconds fade-in and fade-out). A 5 cm × 7 cm sponge electrode was used (the anode was placed in the M1 area, and the cathode was placed in the ipsilateral supraorbital area).	Intervention code：

组别：	对照组	样本量：	10
Group：	control group	Sample size：	10
干预措施：	对照干预为假刺激（仅包含30秒淡入与淡出，无有效电流），每位受试者以随机交叉顺序接受真刺激与假刺激，两次实验间隔7天洗脱期。	干预措施代码：
Intervention：	The control intervention was sham stimulation (only including 30 seconds fade-in and fade-out, without effective current). Each subject received the true stimulation and sham stimulation in a random crossover sequence, and there was a 7-day washout period between the two experiments.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	beijing	City：
单位(医院)：	北京体育大学	单位级别：	大学
Institution hospital：	Beijing Sport University	Level of the institution：	University

测量指标：

Outcomes：

指标中文名：	前手拳动作速度	指标类型：	主要指标
Outcome：	The speed of the initial punch movement	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	启动阶段耗时、击打阶段耗时、回收阶段耗时	指标类型：	主要指标
Outcome：	Startup phase duration, hitting phase duration, recovery phase duration	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	肩关节峰值角速度	指标类型：	主要指标
Outcome：	Peak angular velocity of the shoulder joint	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	积分肌电	指标类型：	主要指标
Outcome：	Integral electromyography	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	均方根振幅	指标类型：	主要指标
Outcome：	Root Mean Square Amplitude	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：	NA	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

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	25	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）：

随机序列由一名不参与实验数据采集的独立研究人员，采用**Excel RAND函数**生成随机数，按受试者纳入顺序分配随机数，并根据随机数大小确定每位受试者第一次实验接受的刺激类型（真刺激或假刺激），第二次实验时所有受试者交叉接受另一种刺激类型（即交叉设计）。随机分组信息在生成后密封保存，直至实验结束。

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

The random sequence was generated by an independent researcher who was not involved in the data collection process. The researcher used the "Excel RAND function" to generate random numbers. These numbers were assigned to the subjects in the order of their inclusion, and based on the size of the random numbers, each subject was assigned the type of stimulus (true or false) they would receive in the first experiment. In the second experiment, all subjects crossed over to receive a different type of stimulus (i.e., a crossover design). The information on random grouping was sealed and kept confidential until the end of the experiment.

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：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	本试验的匿名化个体数据将上传至中国临床试验注册中心推荐的公共管理平台ResMan（www.medresman.org.cn）予以公开。在试验全部完成且研究结果正式发表后6个月内，公众即可在ResMan平台自由查询和下载原始数据。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	The anonymized individual data from this trial will be uploaded to the public management platform ResMan recommended by the Chinese Clinical Trial Registry for public disclosure (www.medresman.org.cn). Within six months after the completion of the trial and the official publication of the research results, the public will be able to freely query and download the original data on the ResMan platform.
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：	本试验使用Microsoft Excel设计结构化的数据采集表格，其功能等同于电子CRF。数据由双人分别独立录入，核对无误后锁定，以Excel文件格式保存在加锁的实验室专用电脑中，并定期进行加密备份
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	In this experiment, a structured data collection form was designed using Microsoft Excel, which functions equivalently to an electronic CRF. The data was independently entered by two individuals, checked for accuracy, and then locked. The data was saved in an encrypted Excel file format on a locked laboratory-specific computer and was regularly backed up for encryption.
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：	2026-05-29 17:51:10