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Influence of motor imaginary therapy on functional magnetic resonance imaging of patients with acute cerebral infarction
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注册号:

Registration number:

ChiCTR-OCC-10001330 

最近更新日期:

Date of Last Refreshed on:

2015-07-11 

注册时间:

Date of Registration:

2010-12-13 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

运动想像疗法对急性脑梗死患者功能磁共振的影响 

Public title:

Influence of motor imaginary therapy on functional magnetic resonance imaging of patients with acute cerebral infarction 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

运动想象疗法对急性脑梗死患者上肢瘫痪的效果及脑功能MRI的改变 

Scientific title:

Effect and change of movement imagine therapy on acute cerebral infarction patients with upper limb paralysis and brain functional MRI 

研究课题代号(代码):

Study subject ID:

2010-1-54 

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:

冉茂胜 

研究负责人:

冉茂胜 

Applicant:

Maosheng Ran 

Study leader:

Maosheng Ran 

申请注册联系人电话:

Applicant telephone:

+86 13919171770 

研究负责人电话:

Study leader's telephone:

+86 13919171770 

申请注册联系人传真 :

Applicant Fax:

+86 931 8362771 

研究负责人传真:

Study leader's fax:

+86 931 8362771 

申请注册联系人电子邮件:

Applicant E-mail:

moscn@163.com 

研究负责人电子邮件:

Study leader's E-mail:

moscn@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:

兰州市靖远路388号 

研究负责人通讯地址:

兰州市靖远路388号 

Applicant address:

388 Jingyuan Road, Lanzhou, Gansu, China 

Study leader's address:

388 Jingyuan Road, Lanzhou, Gansu, China 

申请注册联系人邮政编码:

Applicant postcode:

730046 

研究负责人邮政编码:

Study leader's postcode:

730046 

申请人所在单位:

兰州市第二人民医院 

Applicant's institution:

No.2 hospital of Lanzhou 

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:

CHiECRCT-2011015 

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:

中国临床试验注册中心 

Name of the ethic committee:

Chinese Clinical Trial Register 

伦理委员会批准日期:

Date of approved by ethic committee:

2011-04-17 

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:

兰州市第二人民医院 

Primary sponsor:

No.2 hospital of Lanzhou 

研究实施负责(组长)单位地址:

兰州市金昌路75号 

Primary sponsor's address:

388 Jingyuan Road, Lanzhou, Gansu, 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):

甘肃

市(区县):

Country:

China

Province:

Gansu

City:

单位(医院):

兰州市科技局

具体地址:

城关区金昌北路75号

Institution
hospital:

Bureau of Science

Address:

75 Jinchang Road, Lanzhou

国家:

中国

省(直辖市):

甘肃

市(区县):

Country:

China

Province:

Gansu

City:

单位(医院):

兰州市卫生局

具体地址:

兰州市卫生局

Institution
hospital:

Lanzhou city health bureau

Address:

Lanzhou city health bureau

经费或物资来源:

兰州市科技攻关计划项目 

Source(s) of funding:

Lanzhou Torch-plan Projects 

研究疾病:

急性期脑梗死 

Target disease:

Acute cerebral infarction 

研究疾病代码:

ICD:I63.9 

Target disease code:

ICD:I63.9 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

探讨运动想像疗法对急性期脑梗死偏瘫患者上肢功能恢复的影响,尤其是寻找其在功能磁共振成像测定的血氧水平依赖指标上的变化,为临床工作提供确实依据。 

Objectives of Study:

To study the effects of motor imaginary therapy on the functional outcomes of the upper limb in patients with hemiplegic paralysis, especially to seek the changes of the blood oxygen level measured by functional magnetic resonance imaging, provide conclusive evidence for clinical work. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

(1)经临床症状、体征以及CT或MRI确诊为脑梗死; (2)梗死部位为大脑中动脉供血区; (3)首次发病或虽既往有发作但未遗留神经功能缺损; (4)发病3 d内; (5)人院时意识清楚,Glasgow昏迷量表(GlasgowComaScale,GCS)评分>8分; (6)无明显感觉和智能障碍,即简易精神状态检查(Mini- MentalStatusExamination,MMSE)≥15分; (7)肢体 无严重疼痛或痉挛(修订Ashworth分级≤2级); (8)年龄<70岁。 

Inclusion criteria

1. Diagnosed cerebral infarction by clinical symptoms, physical signs and CT or MRI; 2. The blood of Infarction area is supplied by the middle cerebral artery; 3. The first attack or always attack but not left neurologic deficits 4. Disease within three days; 5. The consciousness is clear when admitted to hospital, score of GCS >8; 6. No obvious feelings and mental retardation, score of MMSE >= 15; 7. Limbs without severe pain or spasm (revised Ashworth classes =< 2); 8. Age<70 years old. 

排除标准:

(1)各种类型的脑出血、蛛网膜下腔出血和短暂性脑缺血发作(TIA); (2)病情恶化,出现新发脑梗死或继发脑出血或大面积脑梗死;(3)有癫痫发作史或有任何发作临床表现者; (4)严重心肺、肝、肾功能不全者; (5)感觉性失语、严重记忆障碍、注意障碍、视觉障碍及交流障碍; (6)存在明显颅内压增高征象。 

Exclusion criteria:

1. All kinds of cerebral hemorrhage, subarachnoid hemorrhage and transient ischemic attack (TIA); 2. The state of the illness deteriorates, appear new cerebral infarction or subsequent cerebral hemorrhage or massive cerebral infarction; 3. Have epilepsy history or have any attack clinical manifestations; 4. Serious damaged cardiopulmonary, liver and kidney function; 5. Sensory aphasia, severe memory disorders, attention deficit, visual obstacle and exchange barrier; 6. The performance of obvious intracranial pressure heighten 

研究实施时间:

Study execute time:

From2009-08-01To 2011-05-31 

干预措施:

Interventions:

组别:

A

样本量:

50

Group:

A

Sample size:

干预措施:

治疗组在常规治疗同时进行运动想像治疗

干预措施代码:

Intervention:

The treatment group receives conventional therapy combined with motor imaginary therapy.

Intervention code:

组别:

B

样本量:

50

Group:

B

Sample size:

干预措施:

对照组常规治疗

干预措施代码:

Intervention:

The treatment group receives conventional therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

甘肃 

市(区县):

 

Country:

China 

Province:

Gansu 

City:

 

单位(医院):

兰州市第二人民医院 

单位级别:

市级 

Institution
hospital:

The Second People's Hospital of Lanzhou  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

FMA、 FIM 量表、fMRI-BOLD 测定

指标类型:

主要指标 

Outcome:

Measure the changes of FMA, FIM and fMRI-BOLD scale

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 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):

计算机软件

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

computer generation

盲法:

医生和病人 否

Blinding:

Doctors and patients: no

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

兰州市第二人民医院

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

No.2 hospital of Lanzhou

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:

兰州市第二人民医院

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

No.2 hospital of Lanzhou

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2010-12-13
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