脑血管疾病危险因素防控、诊疗、康复关键技术研究

注册号:

Registration number:

ChiCTR-OCH-12002238 

最近更新日期:

Date of Last Refreshed on:

2015-08-17 15:39:44 

注册时间:

Date of Registration:

2012-06-04 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

脑血管疾病危险因素防控、诊疗、康复关键技术研究

Public title:

The study of key technology for preventing and controlling the risk factors of cerebrovascular disease, diagnosing and treatment cerebrovascular disease and rehabilitation of cerebrovascular disease

注册题目简写:

English Acronym:

研究课题的正式科学名称:

脑血管病整体康复适宜技术的开发推广及康复信息平台的建设

Scientific title:

The development of appropriate technology for integral rehabilitation of cerebrovascular disease and the construction of Rehabilitation information platform

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:

赵军 

研究负责人:

张通 

Applicant:

Zhao Jun 

Study leader:

Zhang Tong 

申请注册联系人电话:

Applicant telephone:

+86 010 87569491

研究负责人电话:

Study leader's
telephone:

+86 010 87569678

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:

zaojun@sohu.com

研究负责人电子邮件:

Study leader's E-mail:

zt61611@sohu.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:

中国康复研究中心北京市丰台区角门北路10号

研究负责人通讯地址:

中国康复研究中心北京市丰台区角门北路10号

Applicant address:

China Rehabilitation Research Center, 10 North Jiaomen Road, Fengtai district, Beijing, China

Study leader's address:

China Rehabilitation Research Center, 10 North Jiaomen Road, Fengtai district, Beijing, 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:

中国康复研究中心

Applicant's institution:

China Rehabilitation Research Center

研究负责人所在单位:

Affiliation of the Leader:

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:

NA

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

中国康复研究中心伦理委员会

Name of the ethic committee:

China Rehabilitation Research Center Ethics Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2012-03-20 00:00:00

伦理委员会联系人:

Contact Name of the ethic committee:

伦理委员会联系地址:

Contact Address of the ethic committee:

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:

中国康复研究中心

Primary sponsor:

China Rehabilitation Research Center

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:

10 North Jiaomen Road, Fengtai district, Beijing, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

“十二五”国家科技支撑计划

Source(s) of funding:

12.5 State Science and Technic Major Project

研究疾病:

脑血管病  

Target disease:

cerebrovascular disease

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:

队列研究 

Study design:

Cohort study 

研究目的:

(1)推广适用于脑血管病患者不同时期(早期、亚急性期和恢复期,以及社区和家庭康复)的整体康复适宜技术; (2)开发新的康复适宜技术(①虚拟现实环境训练技术 ②主动音乐疗法 ③运动想象治疗 ④重复经颅磁刺激治疗技术 ⑤合理情绪行为疗法); (3)建设脑血管病康复信息平台:包括基于 ICF分类标准的脑血管病康复数据库及远程康复会诊、培训和训练指导系统。  

Objectives of Study:

1. To generalize the appropriate, integral rehabilitation technology for cerebrovascular disease pati-ents in different stages(early stage,subacute stage and convalescent stage, and Community and family rehabilitation); 2. develop the new appropriate rehabilitation technology (1) virtual reality environment technology training; (2) active music therapy; (3) Motor imagine treatment; (4) Repeat transcranial magnetic stimul-ation treatment technology; (5) Rational-Emotion Behaviour Therapy. 3. construct the Rehabilitation information platform: including cerebrovascular disease rehabi-litation databases and remote consultation, training and guidance system for rehabilitation.

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)不符合初发或复发脑血管病的诊断标准;
(2)年龄<18 岁;
(3)患者或家属不签属知情同意书。

Exclusion criteria:

1. Not meet the first or relapse cerebrovascular disease diagnosis standard;
2. less than 18 years old;
3. patients or their family members did not sign the informed consent form.

研究实施时间:

Study execute time:

From 2012-01-01 00:00:00 To 2015-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2012-01-01 00:00:00 To 2015-12-31 00:00:00

干预措施:

Interventions:

组别:

新康复适宜技术组

样本量:

300

Group:

new appropriate rehabilitation technology

Sample size:

干预措施:

虚拟现实环境训练技术

干预措施代码:

Intervention:

virtual reality environment technolog-y training

Intervention code:

组别:

新康复适宜技术组

样本量:

120

Group:

new appropriate rehabilitation technology

Sample size:

干预措施:

主动音乐疗法

干预措施代码:

Intervention:

active music therapy

Intervention code:

组别:

新康复适宜技术组

样本量:

200

Group:

new appropriate rehabilitation technology

Sample size:

干预措施:

重复经颅磁刺激治疗技术

干预措施代码:

Intervention:

Repeat transcranial magnetic stimul-ation treatmen

Intervention code:

组别:

新康复适宜技术组

样本量:

120

Group:

new appropriate rehabilitation technology

Sample size:

干预措施:

合理情绪行为疗法

干预措施代码:

Intervention:

Rational-Emotion Behaviour Therapy

Intervention code:

组别:

新康复适宜技术组

样本量:

120

Group:

new appropriate rehabilitation technology

Sample size:

干预措施:

运动想象治疗

干预措施代码:

Intervention:

Motor imagine treatment

Intervention code:

组别:

推广现有成熟技术组

样本量:

3140

Group:

generalize existing mature technology

Sample size:

干预措施:

现有成熟技术

干预措施代码:

Intervention:

Existing mature technology

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):

丰台区 

Country:

China

Province:

Beijing

City:

Fengtai district

单位(医院):

中国康复研究中心 

单位级别:

三级甲等医院 

Institution
hospital:

hina Rehabilitation Research Center

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民解放军总医院第一附属医院 

单位级别:

三级甲等医院 

Institution
hospital:

Chinese people's liberation army general hospital first affiliated hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

甘肃省 

市(区县):

 

Country:

China

Province:

Gansu

City:

单位(医院):

中国人民解放军兰州军区兰州总医院 

单位级别:

三级甲等医院 

Institution
hospital:

Chinese people's liberation army lanzhou military area commands lanzhou general hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学第一医院 

单位级别:

三级甲等医院 

Institution
hospital:

Peking University First Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

江苏省 

市(区县):

 

Country:

China

Province:

Jiangsu

City:

单位(医院):

南京医科大学第一附属医院 

单位级别:

三级甲等医院 

Institution
hospital:

Nanjing medical university first affiliated hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学第三医院 

单位级别:

三级甲等医院 

Institution
hospital:

Peking University Third Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学第三医院 

单位级别:

三级甲等医院 

Institution
hospital:

Peking University Third Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

黑龙江 

市(区县):

 

Country:

China

Province:

Hei Longjiang

City:

单位(医院):

哈尔滨医科大学附属第二医院 

单位级别:

三级甲等医院 

Institution
hospital:

Harbin medical university hospital affiliated second

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

中国医学科学院北京协和医院 

单位级别:

三级甲等医院 

Institution
hospital:

Chinese academy of medical sciences Beijing union medical college hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

四川省 

市(区县):

 

Country:

China

Province:

Sichuan

City:

单位(医院):

四川大学华西医院 

单位级别:

三级甲等医院 

Institution
hospital:

Huaxi Hospital of Sichuan University

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

山东省 

市(区县):

 

Country:

China

Province:

Shandong

City:

单位(医院):

青岛大学医学院附属医院 

单位级别:

三级甲等医院 

Institution
hospital:

the affiliated hospital of medical college Qingdao University

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京友谊医院 

单位级别:

三级甲等医院 

Institution
hospital:

Beijing Friendship Hospital Attached of Capital Medical University

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民解放军北京军区总医院 

单位级别:

三级甲等医院 

Institution
hospital:

Chinese people's liberation army general hospital of Beijing military area

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

湖北省 

市(区县):

 

Country:

China

Province:

Hubei

City:

单位(医院):

华中科技大学同济医学院附属协和医院 

单位级别:

三级甲等医院 

Institution
hospital:

Union Hospital affiliated Tongji Medical College Huazhong University of Science and Technology

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

河北省 

市(区县):

 

Country:

China

Province:

Hebei

City:

单位(医院):

河北省人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

Hebei people's hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学宣武医院 

单位级别:

三级甲等医院 

Institution
hospital:

Xuanwu Hospital of Capital Medical University

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学 

单位级别:

大学 

Institution
hospital:

Capital Medical University

Level of the institution:

university

国家:

中国

省(直辖市):

新疆维吾尔自治区 

市(区县):

 

Country:

China

Province:

Xinjiang Uyghur Autonomous Region

City:

单位(医院):

新疆维吾尔自治区人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

Xinjiang uygur autonomous region people's hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

广东省 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

中山大学附属第二医院 

单位级别:

三级甲等医院 

Institution
hospital:

The second affiliated hospital of sun yat-sen university

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京天坛医院 

单位级别:

三级甲等医院 

Institution
hospital:

Beijing Tiantan Hospital affiliated Capital Medical University

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

中日友好医院 

单位级别:

三级甲等医院 

Institution
hospital:

China-Japan Friendship Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

广东省 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

中山大学附属第三医院 

单位级别:

三级甲等医院 

Institution
hospital:

the Third Affiliated Hospital of Sun Yat-sen University

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

甘肃省 

市(区县):

 

Country:

China

Province:

Gansu

City:

单位(医院):

兰州大学第二医院 

单位级别:

三级甲等医院 

Institution
hospital:

the Second Hospital Affiliated to Lanzhou University

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

甘肃省 

市(区县):

 

Country:

China

Province:

Gansu

City:

单位(医院):

兰州大学第二医院 

单位级别:

三级甲等医院 

Institution
hospital:

the Second Hospital Affiliated to Lanzhou University

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

辽宁 

市(区县):

 

Country:

China

Province:

Liaoning

City:

单位(医院):

中国医科大学附属盛京医院 

单位级别:

三级甲等医院 

Institution
hospital:

ShengJing Hospital of China Medical University

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

上海市 

市(区县):

 

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属华山医院 

单位级别:

三级甲等医院 

Institution
hospital:

Huashan Hospital Affiliated to Fudan University

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

云南省 

市(区县):

 

Country:

China

Province:

Yunnan

City:

单位(医院):

云南省第二人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

The 2th people Hospital of YunNan Province

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

贵州省 

市(区县):

 

Country:

China

Province:

Guizhou

City:

单位(医院):

贵阳医学院附属医院 

单位级别:

三级甲等医院 

Institution
hospital:

Affiliated Hospital of Guiyang Medical College

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

云南省 

市(区县):

 

Country:

China

Province:

Yunnan

City:

单位(医院):

昆明医学院第二附属医院 

单位级别:

三级甲等医院 

Institution
hospital:

second hospital affiliated Kunming medical college

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

新疆维吾尔自治区 

市(区县):

 

Country:

China

Province:

Xinjiang Uyghur Autonomous Region

City:

单位(医院):

新疆医科大学第一附属医院 

单位级别:

三级甲等医院 

Institution
hospital:

the First Affiliated Hospital of Xinjiang Medical University

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

上海市 

市(区县):

 

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属中山医院 

单位级别:

三级甲等医院 

Institution
hospital:

sun yat-sen hospital affiliated Fudan university

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

浙江省 

市(区县):

 

Country:

China

Province:

Zhejiang

City:

单位(医院):

温州医学院附属第二医院 

单位级别:

三级甲等医院 

Institution
hospital:

the second hospital affiliated Wenzhou medical college

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

卫生部北京医院 

单位级别:

三级甲等医院 

Institution
hospital:

Beijing Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民解放军总医院 

单位级别:

三级甲等医院 

Institution
hospital:

General Hospital of PLA

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

上海市 

市(区县):

 

Country:

China

Province:

Shanghai

City:

单位(医院):

华东医院 

单位级别:

三级甲等医院 

Institution
hospital:

Huadong Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

天津市 

市(区县):

 

Country:

China

Province:

Tianjin

City:

单位(医院):

天津市环湖医院 

单位级别:

三级甲等医院 

Institution
hospital:

TianJin Huanhu Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

重庆市 

市(区县):

 

Country:

China

Province:

Chongqing

City:

单位(医院):

中国人民解放军第三军医大学 

单位级别:

大学 

Institution
hospital:

the Chinese People's Liberation Army third Military Medical University

Level of the institution:

university

国家:

中国

省(直辖市):

陕西省 

市(区县):

 

Country:

China

Province:

Shanxi

City:

单位(医院):

中国人民解放军第四军医大学 

单位级别:

大学 

Institution
hospital:

he Chinese People's Liberation Army fourth Military Medical University

Level of the institution:

university

国家:

中国

省(直辖市):

安徽省 

市(区县):

 

Country:

China

Province:

Anhui

City:

单位(医院):

安徽省立医院 

单位级别:

三级甲等医院 

Institution
hospital:

Anhui provincial hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

广东省 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

深圳市第二人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

Shenzhen second people's hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

广东省 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

暨南大学 

单位级别:

大学 

Institution
hospital:

Jinan University

Level of the institution:

university

国家:

中国

省(直辖市):

浙江省 

市(区县):

 

Country:

China

Province:

Zhejiang

City:

单位(医院):

浙江大学 

单位级别:

大学 

Institution
hospital:

Zhejiang University

Level of the institution:

university

国家:

中国

省(直辖市):

江苏省 

市(区县):

 

Country:

China

Province:

Jiangsu

City:

单位(医院):

南京市第一医院 

单位级别:

三级甲等医院 

Institution
hospital:

The first hospital in nanjing

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

吉林省 

市(区县):

 

Country:

China

Province:

Jilin

City:

单位(医院):

北华大学附属医院 

单位级别:

三级甲等医院 

Institution
hospital:

The hospital of north China university

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

河南省 

市(区县):

 

Country:

China

Province:

Henan

City:

单位(医院):

郑州大学第二附属医院 

单位级别:

三级甲等医院 

Institution
hospital:

The second hospital affiliated zhengzhou university

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

湖北省 

市(区县):

 

Country:

China

Province:

Hubei

City:

单位(医院):

华中科技大学同济医学院附属同济医院 

单位级别:

三级甲等医院 

Institution
hospital:

Tongji Hospital Affiliated to Tongji Medical College Huazhong University of Science and Technology

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

宁夏回族自治区 

市(区县):

 

Country:

China

Province:

Ningxia Hui Autonomous Region

City:

单位(医院):

宁夏医科大学 

单位级别:

大学 

Institution
hospital:

Ningxia Medical University

Level of the institution:

university

国家:

中国

省(直辖市):

广东省 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

南方医科大学 

单位级别:

三级甲等医院 

Institution
hospital:

Southern Medical University

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

四川省 

市(区县):

 

Country:

China

Province:

Sichuan

City:

单位(医院):

四川省医学科学院四川省人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

Sichuan academy of medical sciences, sichuan provincial people's hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

黑龙江 

市(区县):

 

Country:

China

Province:

Hei Longjiang

City:

单位(医院):

哈尔滨医科大学 

单位级别:

大学 

Institution
hospital:

Harbin Medical University

Level of the institution:

university

国家:

中国

省(直辖市):

上海市 

市(区县):

 

Country:

China

Province:

Shanghai

City:

单位(医院):

同济大学 

单位级别:

大学 

Institution
hospital:

Tongji University

Level of the institution:

university

国家:

中国

省(直辖市):

青海省 

市(区县):

 

Country:

China

Province:

Qinghai

City:

单位(医院):

青海省人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

Qinghai province people's hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

上海市 

市(区县):

 

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市第一人民医院分院 

单位级别:

三级甲等医院 

Institution
hospital:

The first people's hospital of Shanghai branch

Level of the institution:

Tertiary A hospital

测量指标:

Outcomes:

指标中文名:

Fugl-Meyer量表

指标类型:

主要指标

Outcome:

Fugl-Meyer scale

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

失语症根据西方失语症成套测验

指标类型:

主要指标

Outcome:

WBA

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视频X线吞咽功能检查

指标类型:

主要指标

Outcome:

videofluoroscopy swallowing study

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

日常生活活动能力

指标类型:

主要指标

Outcome:

activity of daily living

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

MOCA量表

指标类型:

主要指标

Outcome:

MOCA

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

功能磁共振

指标类型:

主要指标

Outcome:

fMRI

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

简易上肢功能检查

指标类型:

主要指标

Outcome:

STEF

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Wolf运动功能量表

指标类型:

主要指标

Outcome:

Wolf Motor Function Test

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:

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 years
最大 Max age 80 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):

由中国康复中心采用整体随机方案产生随机序列

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

random sequence is generated by China rehabilitation cent-er using whole rand-om method

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

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):

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

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:

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

数据与安全监察委员会:

Data and Safety Monitoring Committee:

注册人:

Name of Registration:

 2012-06-07 00:00:00