“醒脑开窍”康复方案治疗中风后运动性失语的队列研究

注册号:

Registration number:

AMCTR-IOC-19000303 

注册号获得时间:

Date of releasing the registration number:

2019/10/23 21:40:35 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

“醒脑开窍”康复方案治疗中风后运动性失语的队列研究 

Public title:

A Cohort Study for 'Xing-Nao Kai-Qiao' Rehabilitation Program in the Treatment of Motor Aphasia after Stroke 

研究课题的正式科学名称:

“醒脑开窍”康复方案治疗中风后运动性失语的队列研究 

Scientific title:

A Cohort Study for 'Xing-Nao Kai-Qiao' Rehabilitation Program in the Treatment of Motor Aphasia after Stroke 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

张玉凤 

研究负责人:

孟智宏 

Applicant:

Zhang Yufeng 

Study leader:

Meng Zhihong 

申请注册联系人电话:

Applicant telephone:

+86 18623686407 

研究负责人电话:

Study leader's telephone:

+86 18722699933 

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:

1136329535@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

yj1988mzh@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:

天津市南开区鞍山西道314号 

研究负责人通讯地址:

天津市南开区鞍山西道314号 

Applicant address:

314 West Anshan Road, Nankai District, Tianjin, China 

Study leader's address:

314 West Anshan Road, Nankai District, Tianjin, 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:

天津中医药大学第一附属医院 

Applicant's institution:

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

研究实施负责(组长)单位:

天津中医药大学第一附属医院 

Primary sponsor:

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

天津市南开区鞍山西道314号 

Primary sponsor's address:

314 West Anshan Road, Nankai District, Tianjin, 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):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津中医药大学第一附属医院

具体地址:

天津市南开区鞍山西道314号

Institution
hospital:

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Address:

314 West Anshan Road, Nankai District

经费或物资来源:

中央财政专项经费 

Source(s) of funding:

Central government special funds 

研究疾病:

中风后运动性失语 

Target disease:

Motor Aphasia after Stroke 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

探讨“醒脑开窍”康复方案治疗中风后运动性失语的时效规律 

Objectives of Study:

Exlore the time-effect rule of the "invigorating brain rehabilitation" treatment program to treat motor aphasia after stroke 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

(1)符合中风后运动性失语的诊断标准; (2)首次出现中风后失语; (3)观察组1:中风急性期,即发病时间≤14天; 观察组2:中风恢复期部分,即15天≤发病时间≤3个月。 (4)失语症严重程度0-3级,能配合进行言语训练; (5)意识清醒,生命体征平稳; (6)年龄 45~75岁; (7)本人或家属签署知情同意书,门诊治疗依从性良好。 

Inclusion criteria

(1) meet the diagnostic criteria for motor aphasia after stroke; (2) Aphasia appears for the first time after stroke; (3) group 1: in the acute stroke period within 14 days after the onset; group 2: in the stroke recovery period between 15 days to 3 months after onset; (4) The severity of aphasia is 0-3, which can be used in conjunction with speech training; (5) Consciousness of consciousness and stable vital signs; (6) Aged 45 to 75 years old; (7) Patient or family signed an informed consent form, and the outpatient with good compliance. 

排除标准:

(1)合并有肝、肾、造血系统和内分泌系统等严重原发性疾病; (2)有视听异常、严重认知障碍、精神性疾病, 不能配合检查和治疗; (3)妊娠、哺乳期妇女。 

Exclusion criteria:

(1) combined with severe primary diseases such as liver, kidney, hematopoietic system and endocrine system; (2) There are abnormalities in audio-visual, severe cognitive impairment, and mental illness, which cannot be combined with examination and treatment; (3) Pregnant and lactating women. 

研究实施时间:

Study execute time:

From2018-12-01To 2021-12-31 

干预措施:

Interventions:

组别:

观察组1

样本量:

100

Group:

Group 1

Sample size:

干预措施:

醒脑开窍针刺法+语言训练

干预措施代码:

Intervention:

'Xing-Nao Kai-Qia' acupuncture therapy plus Language training

Intervention code:

组别:

观察组2

样本量:

100

Group:

Group 2

Sample size:

干预措施:

醒脑开窍针刺法+语言训练

干预措施代码:

Intervention:

'Xing-Nao Kai-Qia' acupuncture therapy plus Language training

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

西方失语症成套测验

指标类型:

主要指标 

Outcome:

Western Aphasia Battery

Type:

Primary indicator 

指标中文名:

功能性语言沟通能力检查法

指标类型:

主要指标 

Outcome:

Functional Language Communication Capability Check

Type:

Primary indicator 

指标中文名:

波士顿失语症严重程度分级

指标类型:

次要指标 

Outcome:

Boston Diagnostic Aphasia Examination

Type:

Secondary indicator 

指标中文名:

美国国立院神经功能缺损评分(NIHSS)

指标类型:

次要指标 

Outcome:

NIH Stroke Scale

Type:

Secondary indicator 

指标中文名:

SAQOL-39生活质量量表评分

指标类型:

次要指标 

Outcome:

SAQOL-39 Quality of Life Scale

Type:

Secondary indicator 

指标中文名:

脑卒中专用生活质量量表(SS-QOL)

指标类型:

次要指标 

Outcome:

Stroke-specific quality of life scale

Type:

Secondary indicator 

指标中文名:

中医健康量表

指标类型:

主要指标 

Outcome:

the Health Scale of Traditional Chinese Medicine

Type:

Primary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

Blepharospasm Disability Index

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 45 years
最大 Max age 75 years

随机方法(请说明由何人用什么方法产生随机序列):

根据发病阶段形成2个队列。

性别:

男性

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

N/A, Two cohorts are formed according to the stage of the disease

Gender:

Male

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

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):

向主要研究者申请后公开

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

Apply to the main researcher for publication.

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

纸质CRF和EDC系统共同使用。

The repository and management of the data(Please specify what repository will be used for management of the metadata):

Paper CRF and EDC systems are used together.

创建人:

Creater Name:

 2019-10-22
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