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定向肌肉神经移植再生术(Targeted Muscle Reinnervation)后肌电驱动的仿生假肢替代上臂水平断臂患肢功能的探索性研究
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注册号:

Registration number:

ChiCTR-ONC-17014163 

最近更新日期:

Date of Last Refreshed on:

2017-12-27 

注册时间:

Date of Registration:

2017-12-26 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

定向肌肉神经移植再生术(Targeted Muscle Reinnervation)后肌电驱动的仿生假肢替代上臂水平断臂患肢功能的探索性研究 

Public title:

Compensating the upper limb function by using targeted muscle reinnervation strategy to motivate the myoelectric prosthesis: an exploratory study  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

定向肌肉神经移植再生术(Targeted Muscle Reinnervation)后肌电驱动的仿生假肢替代上臂水平断臂患肢功能的探索性研究 

Scientific title:

Compensating the upper limb function by using targeted muscle reinnervation strategy to motivate the myoelectric prosthesis: an exploratory study  

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:

冯俊涛 

研究负责人:

徐文东 

Applicant:

JUNTAO FENG 

Study leader:

WENDONG XU 

申请注册联系人电话:

Applicant telephone:

+86 18101614956 

研究负责人电话:

Study leader's telephone:

+86 13501961024 

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:

gentlvon@126.com 

研究负责人电子邮件:

Study leader's E-mail:

wendongxu@fudan.edu.cn 

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:

上海市静安区乌鲁木齐中路12号 

研究负责人通讯地址:

上海市静安区乌鲁木齐中路12号 

Applicant address:

12 Wulumuqi Middle Road, Jing'an District, Shanghai, China 

Study leader's address:

12 Wulumuqi Middle Road, Jing'an District, Shanghai, 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:

复旦大学附属华山医院 

Applicant's institution:

Huashan Hospital, 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:

2016-329 

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:

复旦大学附属华山医院伦理审查委员会 

Name of the ethic committee:

Huashan Institutional Review Board 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-09-20 

伦理委员会联系人:

吴翠云 

Contact Name of the ethic committee:

CUI YUN WU 

伦理委员会联系地址:

上海市乌鲁木齐中路12号 

Contact Address of the ethic committee:

12 Wulumuqi Middle Road, Jing'an District, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 021-52888045 

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:

复旦大学附属华山医院 

Primary sponsor:

Huashan Hospital, Fudan University 

研究实施负责(组长)单位地址:

上海市静安区乌鲁木齐中路12号 

Primary sponsor's address:

12 Wulumuqi Middle Road, Jing'an District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属华山医院

具体地址:

上海市静安区乌鲁木齐中路12号

Institution
hospital:

Huashan Hospital, Fudan University

Address:

12 Wulumuqi Middle Road, Jing'an District, Shanghai, China

经费或物资来源:

上海市科委重中之重项目 

Source(s) of funding:

The top priority project of Shanghai 

研究疾病:

上臂截肢 

Target disease:

upper arm amputation 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

证实上臂水平断臂患者可以通过定向肌肉神经移植再生术(Target Muscle Reinnervation)来重建正中、桡、尺、肌皮神经的信号传出,通过肌电驱动的仿生学假肢来替代断臂后缺失患肢,重建患侧上肢的功能。 

Objectives of Study:

To prove that through target muscle reinnervation technique, we can restore the signals of the ulnar, radial, median and musculocutaneous nerves in upper arm amputation patients and exploit these signals for the motivation of bionic prosthesis in compensation of the function of the defected limb. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

(1)各类原因导致的上臂水平断臂患者; (2)智力和语言功能正常 (3)年龄<45周岁,男女不限 (4)本人有通过手术改善残缺肢体功能的愿望 

Inclusion criteria

(1) upper limb amputation patients caused by different reasons; (2) Normal intelligance and language ability; (3) aged below 45 years old, male or female; (4) Willing to improve the upper limb ability through surgery. 

排除标准:

(1)有糖尿病、高血压等严重系统性疾病不能耐受手术; (2)个人原因或家属强烈要求终止手术者; (3)精神及心理异常者; 

Exclusion criteria:

1. diabetes mellitus, hypertension or other severe system disease, or cant tolerant the surgery; 2. the patient or relatives demand to end the surgery or treatment; 3. Mental or psychological disease. 

研究实施时间:

Study execute time:

From2016-10-01To 2019-10-01 

征募观察对象时间:

Recruiting time:

From2016-10-01To 2019-10-01 

干预措施:

Interventions:

组别:

Case series

样本量:

10

Group:

Case series

Sample size:

干预措施:

TMR术后驱动肌电假肢

干预措施代码:

Intervention:

TMR surgery with myoelectronic prosthesis

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:

三级医院 

Institution
hospital:

Huashan hospital of Fudan university  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

ARAT量表

指标类型:

主要指标 

Outcome:

ARAT 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:

DASH量表

指标类型:

次要指标 

Outcome:

DASH 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:

SHAP 量表

指标类型:

次要指标 

Outcome:

SHAP 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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 15 years
最大 Max age 55 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

由于只有一组,实验本身不随机

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

No randomization since there is only one group

盲法:

Blinding:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

在Resman公开

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

sharing in Resman

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:

使用纸质文档

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

Using scale book

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2017-12-26
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