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注册号: Registration number: |
ChiCTR-OCH-12002238 |
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最近更新日期: Date of Last Refreshed on: |
2015-08-17 15:39:44 |
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注册时间: Date of Registration: |
2012-06-04 00:00:00 |
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注册号状态: |
补注册 |
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Registration Status: |
Retrospective registration |
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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 |
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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 |
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注册题目简写: |
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English Acronym: |
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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 |
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Scientific title: |
The development of appropriate technology for integral rehabilitation of cerebrovascular disease and the construction of Rehabilitation information platform |
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研究课题代号(代码): Study subject ID: |
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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: |
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申请注册联系人: |
赵军 |
研究负责人: |
张通 |
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Applicant: |
Zhao Jun |
Study leader: |
Zhang Tong |
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申请注册联系人电话: Applicant telephone: |
+86 010 87569491 |
研究负责人电话:
Study leader's |
+86 010 87569678 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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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 |
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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): |
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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 |
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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 |
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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: |
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申请人所在单位: |
中国康复研究中心 |
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Applicant's institution: |
China Rehabilitation Research Center |
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研究负责人所在单位: |
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Affiliation of the Leader: |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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: |
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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 |
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Name of the ethic committee: |
China Rehabilitation Research Center Ethics Committee |
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伦理委员会批准日期: Date of approved by ethic committee: |
2012-03-20 00:00:00 | ||
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伦理委员会联系人: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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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: |
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研究实施负责(组长)单位: |
中国康复研究中心 |
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Primary sponsor: |
China Rehabilitation Research Center |
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研究实施负责(组长)单位地址: |
北京市丰台区角门北路10号 |
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Primary sponsor's address: |
10 North Jiaomen Road, Fengtai district, Beijing, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
“十二五”国家科技支撑计划 |
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Source(s) of funding: |
12.5 State Science and Technic Major Project |
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研究疾病: |
脑血管病 |
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Target disease: |
cerebrovascular disease |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
其它 | ||
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Study phase: |
N/A |
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研究设计: |
队列研究 |
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Study design: |
Cohort study |
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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。 |
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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. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
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Inclusion criteria |
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排除标准: |
(1)不符合初发或复发脑血管病的诊断标准; |
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Exclusion criteria: |
1. Not meet the first or relapse cerebrovascular disease diagnosis standard; |
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研究实施时间: Study execute time: |
从 From 2012-01-01 00:00:00至 To 2015-12-31 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2012-01-01 00:00:00 至 To 2015-12-31 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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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 |
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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 |
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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 |
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盲法: |
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Blinding: |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
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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): |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
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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: |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |