今天是:2019-04-22 星期一

机器人辅助步行训练在脑瘫儿童中的应用研究
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注册号:

Registration number:

ChiCTR1900022545 

最近更新日期:

Date of Last Refreshed on:

2019-04-16 

注册时间:

Date of Registration:

2019-04-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

机器人辅助步行训练在脑瘫儿童中的应用研究 

Public title:

Research for application of robot-assisted gait training for children with cerebral palsy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

机器人辅助步行训练在脑瘫儿童中的应用研究 

Scientific title:

Research for application of robot-assisted gait training for children with cerebral palsy 

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:

邱慧莹 

研究负责人:

徐开寿 

Applicant:

Huiying Qiu 

Study leader:

Kaishou Xu 

申请注册联系人电话:

Applicant telephone:

+86 18816791256 

研究负责人电话:

Study leader's telephone:

+86 18902268610 

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:

huiying94@foxmail.com 

研究负责人电子邮件:

Study leader's E-mail:

xksyi@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:

中国广东广州市人民中路318号儿童康复门诊 

研究负责人通讯地址:

中国广东广州市人民中路318号儿童康复门诊 

Applicant address:

318 Renmin Middle Road, Yuexiu District, Guangzhou, Guangdong, China 

Study leader's address:

318 Renmin Middle Road, Yuexiu District, Guangzhou, Guangdong, China 

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:

广州市妇女儿童医疗中心 

Applicant's institution:

Guangzhou Women and Children's Medical Center 

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:

穗妇儿 科伦 通字[2019] 第17000号 

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:

广州市妇女儿童医疗中心科研伦理委员会 

Name of the ethic committee:

Scientific Research Ethics Committee of Guangzhou Women and Children's Medical Center 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-05 

伦理委员会联系人:

曹庆丰 

Contact Name of the ethic committee:

Qingfeng Cao 

伦理委员会联系地址:

广州市金穗路9号 

Contact Address of the ethic committee:

9 Jinsui Road, Guangzhou, Guangdong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

广州市妇女儿童医疗中心 

Primary sponsor:

Guangzhou Women and Children's Medical Center 

研究实施负责(组长)单位地址:

中国广东广州市人民中路318号 

Primary sponsor's address:

318 Renmin Middle Road, Yuexiu District, Guangzhou, Guangdong, 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):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州市妇女儿童医疗中心

具体地址:

广州市人民中路318号

Institution
hospital:

Guangzhou Women and Children's Medical Center

Address:

318 Renmin Middle Road, Yuexiu District, Guangzhou, Guangdong, China

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

脑性瘫痪 

Target disease:

cerebral palsy 

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:

研究目的:

探究机器人辅助步行训练在脑瘫儿童中的治疗效果,包括在步行质量、体能、粗大运动功能和日常生活活动能力等方面的改善作用。 

Objectives of Study:

Research on effectiveness of robot-assissted gait training for children with cerebral palsy, including gross motor function, walking quality, fitnes, ability of self care and so on. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1.诊断为脑性瘫痪; 2.年龄3-17岁; 3.站立功能、步行功能落后,或步态异常. 

Inclusion criteria

1. diagosed as cererbral palsy; 2. aged from 3 to 17 years; 3. delay on walking and standing or abnormal gait. 

排除标准:

1.骨折未愈合者; 2.髋关节脱位; 3.生命体征不稳定者; 4.感染或发热. 

Exclusion criteria:

1. fracture ununion; 2. dislocation of hip joints(s); 3. with unstable vital signs; 4. being infected or having fever. 

研究实施时间:

Study execute time:

From2019-05-01To 2021-05-01 

干预措施:

Interventions:

组别:

实验组

样本量:

20

Group:

experimental group

Sample size:

干预措施:

机器人辅助步行训练+常规物理治疗

干预措施代码:

Intervention:

robot-assisted gait training+conventional physiotherapy

Intervention code:

组别:

对照组

样本量:

20

Group:

control group

Sample size:

干预措施:

常规物理治疗

干预措施代码:

Intervention:

conventional physiotherapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州市妇女儿童医疗中心 

单位级别:

三甲医院 

Institution
hospital:

Guangzhou Women and Children's Medical Center  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

粗大运动功能测评

指标类型:

主要指标 

Outcome:

gross motor function measure

Type:

Primary indicator 

测量时间点:

治疗前后

测量方法:

量表

Measure time point of outcome:

before and after the treatment

Measure method:

using scale

指标中文名:

6分钟步行测试

指标类型:

次要指标 

Outcome:

6-minute walking test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

10米步行测试

指标类型:

次要指标 

Outcome:

10-meter walking test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

改良Ashworth量表

指标类型:

次要指标 

Outcome:

modified Ashworth scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

日常生活能力评定

指标类型:

次要指标 

Outcome:

assessment of self care

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:

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 3 years
最大 Max age 17 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):

未说明

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

Not stated

盲法:

Open

Blinding:

Open

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

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

2021年5月,投稿杂志

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

May, 2021, for acadamic journals.

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:

病例记录表

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

Case record form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-16
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