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The Combination of Swallowing Training and Acupuncture: an Effective Rehabilitation Method for Post-Stroke Dysphagia
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注册号:

Registration number:

ChiCTR-IOR-14005249 

最近更新日期:

Date of Last Refreshed on:

2014-09-24 

注册时间:

Date of Registration:

2014-09-17 

注册号状态:

 

Registration Status:

 

注册题目:

针刺联合吞咽训练对卒中后吞咽障碍的疗效观察 

Public title:

The Combination of Swallowing Training and Acupuncture: an Effective Rehabilitation Method for Post-Stroke Dysphagia 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

卒中后吞咽障碍的评价及康复治疗 

Scientific title:

Assessment and treatment in patients with dysphagia after stoke 

研究课题代号(代码):

Study subject ID:

NO.JX5B36 

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:

郑婵娟 

研究负责人:

夏文广 

Applicant:

Chanjuan ZHENG 

Study leader:

Wenguang XIA 

申请注册联系人电话:

Applicant telephone:

+86 18971317115 

研究负责人电话:

Study leader's telephone:

+86 13377897278 

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:

chanjuanzheng.student@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

docxwg@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:

湖北省武汉市江汉区菱角湖路11号 湖北省新华医院康复医学科 

研究负责人通讯地址:

湖北省武汉市江汉区菱角湖路11号 湖北省新华医院康复医学科 

Applicant address:

Department of Physical Medicine and Rehabilitation, Hubei Xinhua Hospital, Wuhan, China 

Study leader's address:

Department of Physical Medicine and Rehabilitation, Hubei Xinhua Hospital, Wuhan, 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:

湖北省新华医院 

Applicant's institution:

Hubei Xinhua Hospital 

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:

2012007 

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:

湖北省新华医院伦理委员会 

Name of the ethic committee:

The ethic committee of Hubei Xinhua Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-04-24 

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:

湖北省新华医院 

Primary sponsor:

Hubei Xinhua Hospital 

研究实施负责(组长)单位地址:

湖北省武汉市江汉区菱角湖11号 

Primary sponsor's address:

Department of Physical Medicine and Rehabilitation, Hubei Xinhua Hospital, Wuhan, 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):

湖北省

市(区县):

Country:

China

Province:

Hubei

City:

单位(医院):

湖北省新华医院

具体地址:

湖北省武汉市江汉区菱角湖11号

Institution
hospital:

Hubei Xinhua Hospital

Address:

Department of Physical Medicine and Rehabilitation

经费或物资来源:

湖北省卫生厅 

Source(s) of funding:

Hubei province health department 

研究疾病:

脑卒中 

Target disease:

Stroke 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

探讨针刺联合吞咽训练对卒中后吞咽障碍的疗效 

Objectives of Study:

To assess the effect of swallowing training combined with acupuncture on the swallowing function of patients with post-stroke dysphagia. 

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:

符合 1995 年中华医学会第四次全国脑血管病学术会议修订的《各类脑血管疾病诊断要点》,并经 CT或MRI确诊为脑梗死或脑出血患者;无肺部疾患;年龄在40~80岁之间;意识清楚,能合作;知情同意并签署知情同意书 

Inclusion criteria

Conformity with Diagnosis of Cerebrovascular Disease (1995), the primary diagnosis of stroke with magnetic resonance imaging (MRI) or computerized tomography (CT) scans,an age between 40 and 80 years, the ability to follow instructions and engage in study procedures, and ability to give informed consent. 

排除标准:

合并严重的肝、肾、血液病变以及内分泌系统原发病者;精神失常,或智力及认知功能低下;既往有或同时合并有影响吞咽功能的其他疾病,如头颈部肿瘤、食管肿瘤、颅脑损伤、重症肌无力、格林-巴利等疾病。 

Exclusion criteria:

The presence of serious diseases of the liver, kidney, hematological system or endocrine system, psychiatric disorders, cognitive impairment and some other diseases that can impair swallowing function, such as tumors of the head and neck, esophageal neoplasms, craniocerebral injury, myasthenia gravis, or Guillain-Barre Syndrome. 

研究实施时间:

Study execute time:

From2012-01-20To  

干预措施:

Interventions:

组别:

观察组和对照组

样本量:

486

Group:

Two groups

Sample size:

干预措施:

针刺+吞咽训练 vs 吞咽训练

干预措施代码:

Intervention:

acupuncture + training vs trainin

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

省(直辖市):

市(区县):

23 

Country:

Province:

23 

City:

23 

单位(医院):

323 

单位级别:

23 

Institution
hospital:

232  

Level of the institution:

23 

测量指标:

Outcomes:

指标中文名:

标准吞咽障碍评分

指标类型:

主要指标 

Outcome:

Standardized Swallowing Assessment

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

吞咽透视检查评分

指标类型:

主要指标 

Outcome:

Videofluoroscopic 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:

日常生活能力评分

指标类型:

主要指标 

Outcome:

Modified Barthel Index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

吞咽生活质量评分

指标类型:

主要指标 

Outcome:

Swallowing-Related Quality of Life

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 40 years
最大 Max age 78 years

性别:

Gender:

随机方法(请说明由何人用什么方法产生随机序列):

利用随机数字表将研究对象随机分为实验组和对照组

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

The subjects were randomly divided into two groups selected by randomization with a 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):

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:

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-09-17
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