4-6岁学龄前儿童运动协调性发育动力学研究

注册号:

Registration number:

ChiCTR2500095619 

最近更新日期:

Date of Last Refreshed on:

2025-01-09 14:57:16 

注册时间:

Date of Registration:

2025-01-09 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

4-6岁学龄前儿童运动协调性发育动力学研究

Public title:

Developmental Dynamics research of Motor Coordination in 4-6 Year Old Preschoolers

注册题目简写:

English Acronym:

研究课题的正式科学名称:

4-6岁学龄前儿童运动协调性发育动力学研究

Scientific title:

Developmental Dynamics research of Motor Coordination in 4-6 Year Old Preschoolers

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:

康栩烨 

研究负责人:

李建英 

Applicant:

Xuye Kang 

Study leader:

Jianying Li 

申请注册联系人电话:

Applicant telephone:

+86 155 2500 1618

研究负责人电话:

Study leader's
telephone:

+86 138 0341 2953

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:

202113709002@email.sxu.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

ljy195912@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:

山西省太原市坞城路92号

研究负责人通讯地址:

山西省太原市坞城路92号

Applicant address:

92 Wucheng road, Taiyuan, Shanxi

Study leader's address:

92 Wucheng road, Taiyuan, Shanxi

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:

山西大学

Applicant's institution:

Shanxi University

研究负责人所在单位:

山西大学

Affiliation of the Leader:

Shanxi 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:

SXULL2024082

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:

山西大学科学研究伦理审查委员会

Name of the ethic committee:

Ethics Committee of Scientific Research in Shanxi University

伦理委员会批准日期:

Date of approved by ethic committee:

2024-05-30 00:00:00

伦理委员会联系人:

成宏

Contact Name of the ethic committee:

Hong Cheng

伦理委员会联系地址:

山西省太原市小店区南中环东街63号

Contact Address of the ethic committee:

63 South Zhonghuan East Street, Xiaodian District, Taiyuan, Shanxi

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 183 3549 2431

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:

山西大学

Primary sponsor:

Shanxi university

研究实施负责(组长)单位地址:

山西省太原市坞城路92号

Primary sponsor's address:

92 Wucheng road, Taiyuan, Shanxi

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

山西

市(区县):

太原

Country:

China

Province:

Shanxi

City:

Taiyuan

单位(医院):

山西大学

具体地址:

山西省太原市坞城路92号

Institution
hospital:

Shanxi University

Address:

92 Wucheng road, Taiyuan, Shanxi

经费或物资来源:

国家社会科学基金

Source(s) of funding:

The National Social Science Fund of China

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:

观察性研究

Study type:

Observational study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

横断面 

Study design:

Cross-sectional 

研究目的:

本研究旨在对学龄前儿童不同时间阶段下,运动协调的发育特征和变异性以及相关素质的发育特征进行对比和相关性分析,对探究人类运动协调发展机制,为学龄前儿童发育性协调障碍的评估和针对性干预提供理论指导。  

Objectives of Study:

The present study aimed to compare and correlate the developmental characteristics and variability of motor coordination and related qualities in preschool children at different stages of time, in order to investigate the developmental mechanisms of human motor coordination and to provide theoretical guidance for targeted motor interventions for preschool children.

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

排除标准:

1)年龄不满4岁或大于6岁;2)确诊视力障碍、心血管疾病或神经肌肉疾病;3)存在智力发育滞后,精神异常、认知或学习障碍;4)6个月内存在转学需求。

Exclusion criteria:

1) be less than 4 years of age or more than 6 years of age; 2) have a confirmed diagnosis of visual impairment, cardiovascular disease, or neuromuscular disease.(3) Have a mental retardation, mental abnormality, cognitive or learning disability; (4) Have a need to transfer to another school within 6 months.

研究实施时间:

Study execute time:

From 2024-06-15 00:00:00 To 2024-11-20 00:00:00  

征募观察对象时间:

Recruiting time:

From 2024-06-15 00:00:00 To 2024-07-01 00:00:00

干预措施:

Interventions:

组别:

组1(月龄48-54)

样本量:

60

Group:

Group 1(Age of mounth between 48-54)

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

组2(月龄55-60)

样本量:

60

Group:

Group 2(Age of mounth between 55-60)

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

组3(月龄61-66)

样本量:

60

Group:

Group 3(Age of mounth between 61-66)

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

组4(月龄67-72)

样本量:

60

Group:

Group 4(Age of mounth between 67-72)

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

组5(月龄73-84)

样本量:

60

Group:

Group 5(Age of mounth between 73-84)

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

山西 

市(区县):

太原 

Country:

China

Province:

Shanxi

City:

Taiyuan

单位(医院):

中北大学附属幼儿园 

单位级别:

无 

Institution
hospital:

Kindergarten Affiliated to North University of China

Level of the institution:

None

国家:

中国

省(直辖市):

山西 

市(区县):

太原 

Country:

China

Province:

Shanxi

City:

Taiyuan

单位(医院):

太行幼儿园 

单位级别:

无 

Institution
hospital:

Taihang Kindergarten

Level of the institution:

None

测量指标:

Outcomes:

指标中文名:

表面肌肉电信号

指标类型:

主要指标

Outcome:

Surface Electromyography(sEMG)

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

三维运动轨迹

指标类型:

主要指标

Outcome:

Three-dimensional trajectory

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

运动协调性

指标类型:

次要指标

Outcome:

Motor coordination

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

上肢协调性

指标类型:

次要指标

Outcome:

Upper-limb coordination

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

基本运动技能

指标类型:

次要指标

Outcome:

Fundamental movement skills

Type:

Secondary 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:

N/A

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 4 years
最大 Max age 6 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:

不公开/Private

盲法:

Blinding:

None

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):

发表文章后;邮件联系

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

After publishing the paper; Contact by email

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

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2025-01-09 14:56:47