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Effect of "Instructional Functional Electrical Stimulation Machine" on early rehabilitation of motor function after cerebral infarction
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注册号:

Registration number:

ChiCTR-TRC-10001159 

最近更新日期:

Date of Last Refreshed on:

2015-07-04 

注册时间:

Date of Registration:

2010-11-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

“信号式功能性电刺激治疗仪”在早期脑梗塞运动功能康复中的应用研究 

Public title:

Effect of "Instructional Functional Electrical Stimulation Machine" on early rehabilitation of motor function after cerebral infarction 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

脑血管病康复治疗新技术开发应用 

Scientific title:

New technique developments for the rehabilitation of cerebral vascular diseases 

研究课题代号(代码):

Study subject ID:

2007AA02Z482 

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:

贾杰 

研究负责人:

吴毅 

Applicant:

Jie JIA 

Study leader:

Yi WU 

申请注册联系人电话:

Applicant telephone:

+86 13611722357 

研究负责人电话:

Study leader's telephone:

+86 021 52887819 

申请注册联系人传真 :

Applicant Fax:

+86 021 52887820 

研究负责人传真:

Study leader's fax:

+86 021 52887820 

申请注册联系人电子邮件:

Applicant E-mail:

drjiajie1@163.com 

研究负责人电子邮件:

Study leader's E-mail:

shannonjj@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:

上海市乌鲁木齐中路12号 

研究负责人通讯地址:

上海市乌鲁木齐中路12号 

Applicant address:

12 Middle Urumqi Road, Shanghai 

Study leader's address:

12 Middle Urumqi Road, Shanghai 

申请注册联系人邮政编码:

Applicant postcode:

200040 

研究负责人邮政编码:

Study leader's postcode:

200040 

申请人所在单位:

复旦大学附属华山医院 

Applicant's institution:

Huasha Hospital of Fudan University 

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:

(2010)临审第(142)号 

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:

复旦大学附属华山医院伦理审查委员会 (HIRB) 

Name of the ethic committee:

Ethics committee of Huasha Hospital of Fudan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2010-08-20 

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:

科技部 

Primary sponsor:

Ministry of Science and Technology of China 

研究实施负责(组长)单位地址:

北京市海淀区复兴路乙15号 

Primary sponsor's address:

15B Fuxin Road, Haidian District, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

省(直辖市):

市(区县):

Country:

Province:

City:

单位(医院):

上海市科学技术委员会

具体地址:

Institution
hospital:

Science and technology commission of Shanghai

Address:

经费或物资来源:

科技部 

Source(s) of funding:

Ministry of Science and Technology of China 

研究疾病:

脑梗塞 

Target disease:

Cerebral infarction 

研究疾病代码:

ICD:I63.9 

Target disease code:

ICD:I63.9 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

通过前瞻性、随机、安慰电刺激对照研究,以上肢运动功能评分(MSS), Brunnstrom分级评分,简化Fugl-Meyer运动功能评分法,改良Ashworth分级法评定标准,功能综合评定量表(Functional Comprehensive Assessment,FCA)等5个量表作为客观量化指标,研究“信号式功能性电刺激治疗仪”在脑梗塞早期运动功能康复中的有效性,评价治疗期间“信号式功能性电刺激治疗仪”的安全性,进一步为该治疗仪的研发及投放市场提供临床有效性依据。 

Objectives of Study:

To evaluate the efficacy and safety of "Instructional Functional Electrical Stimulation Machine" on early rehabilitation of motor function after cerebral infarction based on upper limb motor status scale (MSS), Brunnstrom scale, simplified Fugl-Meyer motor scale, modified Ashworth scale, functional comprehensive assessment (FCA) in the prospective randomized controlled trial. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)40岁≤年龄≤80岁 (2)首次发生脑出血和脑梗死或既往发生过腔隙性脑梗死而无后遗症存在的患者 (3)诊断符合1995年全国第四届脑血管病学术会议通过的各类脑血管病诊断要点 (4)经头颅CT或MRI证实 (5)3天≤发病时间14天,存在肢体功能障碍 (6)患侧肢体的Brunnstrom分级1期 (7)临床试验之前未接受过正规康复治疗 (8)患者本人签署或由其直系亲属代签知情同意书 

Inclusion criteria

(1) Aged between 40 and 80 years old; (2) First onset of cerebral hemorrhage or cerebral infarction; or previous lacunar cerebral infarction without sequelae; (3) In accordance with the diagnosis criteria released in the 4th National Conference on Cerebral Vascular Diseases in 1995; (4) Confirmed by CT or MRI; (5) Onset of the disease between 3 and 14 days, with limbs dysfunction; (6) Brunnstrom scale of affected limbs: stage 1; (7) Receive no standard rehabilitation therapy before the study; (8) Sign informed consent forms. 

排除标准:

(1)意识不清,MMSE量表评价提示痴呆,合并感觉性失语或精神障碍等疾患,不能配合检查及治疗的住院患者 (2)合并心、肝、肾和造血系统等严重原发性疾病的患者 (3)有四肢骨关节疾病所致的运动功能障碍 (4)既往有认知障碍、神经精神病史、药物滥用及酗酒史 (5)有重要脏器功能衰竭或病情危重的脑卒中患者以及癌症等对患者生存质量的影响超过中风后肢体功能障碍的疾病或状态 (6)安置心脏起搏器的患者 (7)不能完成基本疗程,依从性可能不好者(即不能坚持治疗)及难以随访者 (8)前臂及小腿部皮肤有感染、破损者 (9)伴有溃疡及出血倾向疾病的患者 

Exclusion criteria:

(1) With presentation of consciousness disturbances, or with dementia according to MMSE scale, combined with sensory aphasia and psychic disorders that cannot cooperate; (2) Comorbidities with severe primary diseases of heart, liver, kidney and hematological system; (3) Combined with motor dysfunction caused by osteoarthritis diseases; (4) History of cognitive disorders, psychic disorders and drugs or alcohol abuse; (5) Combined with primary organs dysfunction and critically ill patients; or combined with other diseases that might cause more influences the quality of life than the limbs dysfunction after stroke, such as cancer; (6) Patients with cardiac pacemakers; (7) Patients with poor compliance or not suitable for follow-ups; (8) Skin infections or lesions on forearms and legs; (9) With ulcers or diseases that have a tendency to hemorrhage 

研究实施时间:

Study execute time:

From2010-05-01To 2011-05-31 

干预措施:

Interventions:

组别:

A

样本量:

60

Group:

A

Sample size:

干预措施:

传统康复治疗+信号式功能性电刺激安慰治疗(周一至周五:每天一次,每次20分钟,持续八周)

干预措施代码:

Intervention:

conventional rehabilitation training + instructional functional electrical stimulation (placebo; Monday to Friday: 20 minutes per day, for 8 weeks)

Intervention code:

组别:

B

样本量:

60

Group:

B

Sample size:

干预措施:

传统康复治疗+信号式功能性电刺激治疗(周一至周五:每天一次,每次20分钟,持续八周)

干预措施代码:

Intervention:

conventional rehabilitation training + instructional functional electrical stimulation (Monday to Friday: 20 minutes per day, for 8 weeks)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

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:

市级医院(三级甲等) 

Institution
hospital:

Huasha Hospital of Fudan University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

上肢运动功能评分(MSS)

指标类型:

主要指标 

Outcome:

upper-limb MSS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

简化Fugl-Meyer运动功能评分法

指标类型:

次要指标 

Outcome:

simplified Fugl-Meyer motor scale

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 40 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):

随机数字表

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

random number table

盲法:

Blinding:

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):

复旦大学附属华山医院

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

Huasha Hospital of Fudan University

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:

复旦大学附属统计学教研室

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

Statistics division of Huasha Hospital of Fudan University

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2010-11-17
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