ChiCTR2400091744 版本V1.0 版本创建时间2024/11/01 17:33:53 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:

ChiCTR2400091744 

最近更新日期:

Date of Last Refreshed on:

2024-11-01 17:32:41 

注册时间:

Date of Registration:

2024-11-01 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

运动工作记忆独立性研究

Public title:

Independence of kinesthetic working memory

注册题目简写:

English Acronym:

研究课题的正式科学名称:

运动工作记忆独立性研究

Scientific title:

Independence of kinesthetic working memory

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:

魏海涛 

研究负责人:

魏海涛 

Applicant:

Wei haitao 

Study leader:

Wei haitao 

申请注册联系人电话:

Applicant telephone:

+86 13681595892

研究负责人电话:

Study leader's telephone:

+86 10 87569512

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:

weihaitao3@163.com

研究负责人电子邮件:

Study leader's E-mail:

weihaitao3@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:

北京市丰台区角门北路10号

研究负责人通讯地址:

北京市丰台区角门北路10号

Applicant address:

No. 10, Jiaomen North Road,Fengtai District, Beijing

Study leader's address:

No. 10, Jiaomen North Road, Fengtai District

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:

中国康复研究中心北京博爱医院

Applicant's institution:

China Rehabilitation Research Center Beijing Boai Hospital

研究负责人所在单位:

北京博爱医院

Affiliation of the Leader:

Beijing Bo'ai Hospital

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:

2024-116-1

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:

中国康复研究中心医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of China Rehabilitation Research Center

伦理委员会批准日期:

Date of approved by ethic committee:

2024-09-26 00:00:00

伦理委员会联系人:

孟丽君

Contact Name of the ethic committee:

Meng Lijun

伦理委员会联系地址:

北京市丰台区角门北路10号

Contact Address of the ethic committee:

No. 10, Jiaomen North Road, Fengtai District

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10 87020512

伦理委员会联系人邮箱:

Contact email of the ethic committee:

menglydia@126.com

研究实施负责(组长)单位:

北京博爱医院

Primary sponsor:

Beijing Bo'ai Hospital

研究实施负责(组长)单位地址:

北京市丰台区角门北路10号

Primary sponsor's address:

No. 10, Jiaomen North Road, Fengtai District

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):

北京博爱医院

具体地址:

北京市丰台区角门北路10号

Institution
hospital:

Beijing Bo'ai Hospital

Address:

No. 10, Jiaomen North Road, Fengtai District

经费或物资来源:

自选课题(自筹)

Source(s) of funding:

Self-financed project

Target disease:

Stroke

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:

本研究目的通过双任务方法,探索运动工作记忆和听觉语音工作记忆是独立存在的认知成分。  

Objectives of Study:

To investigate the independence of working memory for movement from auditory verbal working memory using a dual-task method in terms of double dissociation.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

1.招募身心健康志愿者 24 人,年龄 20 岁至 39 岁,男女各 12 人,全员右利手,签署知情同意书。

Inclusion criteria

1.The inclusion criteria for the participants were as follows: aged 20–39 years (12 female, 12male). All R‐handed.Sign informed consent.

排除标准:

1.①既往曾患有脑卒中、脑外伤、认知功能障碍、运动发育迟缓、感统失调、右 利手运动障碍者;
2.②服用抗精神和抗癫痫药;
3.③听力障碍者;
4.④视力障碍者;
5.⑤专业运动员;

Exclusion criteria:

1.Stroke, head injury, dementia, motor developmental delay, sensory integration disorders, physical disability of the right hand;
2.Oral antipsychotic drug intake, oral antiepileptic drug intake;
3.Hearing impairments;
4. Vision disorders;
5.Practicing any competitive sports;

研究实施时间:

Study execute time:

From 2024-09-09 00:00:00 To 2026-08-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2024-11-01 00:00:00 To 2025-06-30 00:00:00  

干预措施:

Interventions:

组别:

观察组

样本量:

24

Group:

observations group

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):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京博爱医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Bo'ai Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

得分和广度

指标类型:

主要指标

Outcome:

Scores and spans

Type:

Primary indicator

测量时间点:

即时

测量方法:

1、视觉运动工作记忆任务 视觉运动工作记忆任务通过视屏形式呈现运动,受试者重复相同的运动。评分标准是正确视觉运动工作记忆任务得分和广度。 2、运动感觉运动工作记忆任务 运动感觉运动工作记忆任务通过检查者被动运动受试者形式呈现运动,受试者重复相同的运动。评分标准是正确运动感觉运动工作记忆任务得分和广度。 3、视觉语音工作记忆任务 视觉语音工作记忆任务通过视屏形式呈现字母,受试者重复相同的字母。评分标

Measure time point of outcome:

Immediately

Measure method:

1. Working memory tasks The examiner presents working memory tasks and asks the subject to reproduce it immediately in the same order. The scores represented the number of correctly reproduced scores. The spans represent the number of correctly reproduced spans. 2.Interference tasks (movement and verbal interference) After the participants completed the interference tasks in 15 s, the working memory tasks began. The interference tasks were continued until the working memory tasks were comple

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 39 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):

研究组成员用Latin square design方法产生随机数列

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

Participants were allotted a Latin square

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:

单盲

Blinding:

Single blind study

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):

不共享

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

Not to share

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:

研究组成员进行测试采集数据。所有数据及时填写、准确录入。

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

Members perform tests to collect data. All data were filled in timely and entered accurately.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2024-11-01 17:32:41