ChiCTR2500108139 版本V1.0 版本创建时间2025/08/25 17:45:22 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:

ChiCTR2500108139 

最近更新日期:

Date of Last Refreshed on:

2025-08-25 17:45:05 

注册时间:

Date of Registration:

2025-08-25 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

基于任务约束的球类游戏对发育性协调障碍儿童操控技能的影响

Public title:

The Impact of Constraints-Based Ball Games on the Control Skills of Children with Developmental Coordination Disorder

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于任务约束的球类游戏对DCD儿童操控技能的影响

Scientific title:

The Impact of Constraints-Based Ball Games on the Control Skills of Children with Developmental Coordination Disorder

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:

郭子萌 

研究负责人:

郭子萌 

Applicant:

Guo Zimeng 

Study leader:

Guo Zimeng 

申请注册联系人电话:

Applicant telephone:

+86 187 4125 3330

研究负责人电话:

Study leader's
telephone:

+86 187 4125 3330

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:

m18741253330_2@163.com

研究负责人电子邮件:

Study leader's E-mail:

m18741253330_2@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:

辽宁省大连市沙河口区黄河路850号

研究负责人通讯地址:

辽宁省大连市沙河口区黄河路850号

Applicant address:

850 Huanghe Road, Shahekou District, Dalian, Liaoning, China

Study leader's address:

850 Huanghe Road, Shahekou District, Dalian, Liaoning, China

申请注册联系人邮政编码:

Applicant postcode:

116029

研究负责人邮政编码:

Study leader's postcode:

114200

申请人所在单位:

辽宁师范大学体育学院

Applicant's institution:

School of Physical Education, Liaoning Normal University

研究负责人所在单位:

辽宁师范大学体育学院

Affiliation of the Leader:

School of Physical Education, Liaoning Normal University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

LL2023068

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:

辽宁师范大学伦理委员会

Name of the ethic committee:

Ethics Committee of Liaoning Normal University

伦理委员会批准日期:

Date of approved by ethic committee:

2023-10-09 00:00:00

伦理委员会联系人:

辽宁师范大学科研处

Contact Name of the ethic committee:

Research Department, Liaoning Normal University

伦理委员会联系地址:

辽宁省大连市沙河口区黄河路850号

Contact Address of the ethic committee:

850 Huanghe Road, Shahekou District, Dalian, Liaoning, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 411 8215 9889

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:

辽宁师范大学

Primary sponsor:

Liaoning Normal University

研究实施负责(组长)单位地址:

辽宁省大连市沙河口区黄河路850号

Primary sponsor's address:

850 Huanghe Road, Shahekou District, Dalian, Liaoning, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

辽宁省

市(区县):

Country:

China

Province:

Liaoning

City:

单位(医院):

辽宁师范大学体育学院

具体地址:

辽宁省大连市沙河口区黄河路850号

Institution
hospital:

School of Physical Education, Liaoning Normal University,

Address:

850 Huanghe Road, Shahekou District, Dalian, Liaoning, China

经费或物资来源:

自筹经费

Source(s) of funding:

self-financing

研究疾病:

发育性协调障碍  

Target disease:

Developmental Coordination Disorder

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:

非随机对照试验 

Study design:

Non randomized control 

研究目的:

首先,研究以儿童操控技能为切入点,梳理国内外关于 DCD 儿童运动技能发展的研究现状与发展趋势,借助关键期理论对 DCD 儿童操控技能的特点进行分析,并将 DCD 儿童与 TD 儿童的操控技能发展情况进行对比,分析两种儿童操控技能发展的差异,挖掘 DCD 儿童操控技能发展存在的问题。其次,基于动态系统理论和强化理论,形成科学的球类游戏方案设计理论体系,设计和开发有利于 DCD 儿童操控技能发展的球类游戏干预方案,并检验其有效性。最后,针对球类游戏干预方案的现实应用进一步提出具有操作性的推行建议。以此为 DCD 儿童掌握操控技能提供实施路径,更精准地为儿童操控技能发展指明方向,为其健康发展提供参考与借鉴。  

Objectives of Study:

First of all, the study takes children's manipulative skills as the starting point, compiles the current status and development trend of domestic and international research on the development of motor skills of DCD children, analyses the characteristics of DCD children's manipulative skills with the help of the critical period theory, and compares the development of the manipulative skills of DCD children with that of TD children, analyses the differences in the development of the manipulative skills of these two kinds of children, and digs out the problems that exist in the development of DCD children's manipulative skills. The problem of DCD children's manipulative skill development was analysed. Secondly, based on the dynamic system theory and reinforcement theory, we formed a scientific theoretical system for ball game programme design, and designed and developed a ball game intervention programme that is conducive to the development of DCD children's manipulative skills, and tested its effectiveness. Finally, operational recommendations are proposed for the practical application of the ball game intervention programme. In this way, the programme provides a pathway for children with DCD to master manipulative skills, and points out the direction of children's manipulative skill development in a more precise way, so as to provide reference and reference for their healthy development.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

先通过问卷星对儿童的主要抚养人发放 DCDQ 量表,得分≤57 的儿童进行 MABC-2 测试。DCD 儿童纳入标准:a.自愿参加、家长允许并签署运动干预知情同意书;b.能配合随访;c.DCDQ 测试总分≤57 分,MABC-2 测试得分百分位数≤16%。

Inclusion criteria

The DCDQ was administered to the children's primary caregivers through a questionnaire, and children with a score of <=57 were given the MABC-2 test. Inclusion criteria for children with DCD: a. voluntary participation, parental permission, and signing of informed consent for exercise intervention; b. ability to cooperate with the follow up visit; and c. total score of the DCDQ test ≤57, and the percentile score of MABC-2 test <=16%.

排除标准:

DCD 儿童排除标准:a.服用可能导致运动协调能力障碍的药物;b.存在智力缺陷、视力缺陷、神经疾病及并发症的儿童。

Exclusion criteria:

Exclusion criteria for children with DCD: a. Taking medications that may cause motor coordination deficits; b. Children with intellectual deficits, visual deficits, neurological disorders, and comorbidities.

研究实施时间:

Study execute time:

From 2023-10-10 00:00:00 To 2025-06-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2023-10-10 00:00:00 To 2023-12-31 00:00:00

干预措施:

Interventions:

组别:

试验组

样本量:

11

Group:

Test group

Sample size:

干预措施:

常规球类游戏干预

干预措施代码:

Intervention:

Conventional ball game intervention

Intervention code:

组别:

对照组

样本量:

11

Group:

Control group

Sample size:

干预措施:

基于任务约束设计的球类游戏干预

干预措施代码:

Intervention:

Ball game intervention based on task-constrained design

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

辽宁省 

市(区县):

 

Country:

China

Province:

Liaoning

City:

单位(医院):

南台镇新昌小学 

单位级别:

小学 

Institution
hospital:

Nantai Town Xinchang Primary School

Level of the institution:

Primary School

测量指标:

Outcomes:

指标中文名:

操控技能

指标类型:

主要指标

Outcome:

Manipulation Skills

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:

组织:

Sample Name:

NA

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:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 7 years
最大 Max age 8 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):

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

none

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):

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):

邮件联系m18741253330_2@163.com(2026年12月)

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

Email contact m18741253330_2@163.com (December 2026)

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:

未使用

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

Not used

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:

 2025-08-25 17:45:05