醒脑开窍针刺法结合现代康复技术治疗急性缺血性脑卒中后认知功能障碍的临床研究

注册号:

Registration number:

AMCTR-IOR-18000225 

注册号获得时间:

Date of releasing the registration number:

2018/11/20 10:13:21 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

醒脑开窍针刺法结合现代康复技术治疗急性缺血性脑卒中后认知功能障碍的临床研究 

Public title:

The synergistic effect of consciousness restoring obstruction clearing needing technique and cognitive training on post-stroke cognitive dysfunction 

研究课题的正式科学名称:

醒脑开窍针刺法结合现代康复技术治疗急性缺血性脑卒中后认知功能障碍的临床研究 

Scientific title:

The synergistic effect of consciousness restoring obstruction clearing needing technique and cognitive training on post-stroke cognitive dysfunction 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR1800019505 

申请注册联系人:

覃渝茜 

研究负责人:

茅敏 

Applicant:

Qin Yuxi 

Study leader:

Mao Min 

申请注册联系人电话:

Applicant telephone:

+86 13880908749 

研究负责人电话:

Study leader's telephone:

+86 18108037969 

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:

1582881952@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

1422778067@qq.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:

四川省成都市温江区八一路81号 

研究负责人通讯地址:

四川省成都市高新区万象北路18号 

Applicant address:

81 Bayi Road, Wenjiang District, Chengdu, Sichuan, China 

Study leader's address:

18 North Wanxiang Road, Gaoxin District, Chengdu, Sichuan, 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:

四川省八一康复中心(四川省康复医院) 

Applicant's institution:

Sichuan 81 Rehabilitation Center (Sichuan provincial rehabilitational 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:

CKLL-2018005 

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:

四川省八一康复中心(四川省康复医院) 

Name of the ethic committee:

Sichuan Bayi Rehabilitation Center (Sichuan Provincial Rehabilitational Hospital) 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-10-19 

研究实施负责(组长)单位:

四川省八一康复中心(四川省康复医院) 

Primary sponsor:

Sichuan Bayi Rehabilitation Center (Sichuan Provincial Rehabilitational Hospital) 

研究实施负责(组长)单位地址:

川省八一康复中心(四川省康复医院) 

Primary sponsor's address:

81 Bayi Road, Wenjiang District, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

成都市中西医结合医院

具体地址:

四川省成都市高新区万象北路18号

Institution
hospital:

Chengdu Integrated TCM & Western Medicine Hospital

Address:

18 North Wanxiang Road, Gaoxin District, Chengdu, Sichuan, China

国家:

省(直辖市):

市(区县):

Country:

Province:

City:

单位(医院):

具体地址:

Institution
hospital:

Address:

经费或物资来源:

自筹 

Source(s) of funding:

self-collected 

研究疾病:

脑卒中和认知障碍 

Target disease:

post-stroke cognitive dysfunction 

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:

脑卒中是认知障碍发生最常见的病因,脑卒中后的认知障碍临床发病率高达75%,严重影响患者生活质量。目前临床上多以综合性康复治疗手段治疗卒中后的认知障碍。大量文献证实康复治疗中的认知训练对卒中后患者的认知障碍有明确的治疗作用。在中国,针灸作为传统医学的重要分支,大量文献证实石学敏院士独创的醒脑开窍针刺法能改善卒中后认知功能。考虑到认知障碍病情的复杂性,目前临床治疗以多种方法综合治疗为主,针刺治疗和认知康复训练等现代康复训练对认知功能的临床效果没有进行过系统性的比较,两者联合使用是否具有治疗叠加效应也暂不明确。因此,本文拟设计针刺治疗结合认知康复训练讨论两者是否有协同作用。 

Objectives of Study:

Stroke is one of the most common causes of cognitive impairment. Up to 75% of stroke survivors may be considered to have cognitive impairment, which severely limit individual autonomy for successful reintegration into family, work and social life. In China, the clinical efficacy of consciousness restoring obstruction clearing needing technique in post-stroke cognitive impairment has been previously demonstrated. Conventional cognitive rehabilitation and has also shown to be effective in improvement of cognitive function of affected patients. However, the cognitive impairment after stroke is so complexity that one single treatment cannot resolve effectively. Besides, the effects of acupuncture and cognitive training have not been systematically compared, nor has the possibility of a synergistic effect of combination of the two therapeutic modalities been evaluated. Our primary aim of this trial is to evaluate the synergistic effect of acupuncture and cognitive training on cognitive dysfunction after stroke. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

患者年龄在18岁到75岁之间,病程在2个月内的首次卒中患者(卒中诊断标准依据心血管疾病诊断标准),伴随有认知障碍(认知障碍诊断标准依据简易精神状态量表:文盲≤ 17分,小学文化≤ 20分,中学文化程度≤ 24分),自愿签订知情同意书。 

Inclusion criteria

patients aged 18 to 75 years old, with first-ever stroke in past two months (according to the criteria of Diagnostic Criteria for All Kinds of Cerebrovascular Disease) with cognitive impairments [screened by Mini-Mental Status Examination (MMSE): illiterate (uneducated) group ≤ 17points; primary school (years of education ≤ 6 years) group ≤ 20 points; middle school or higher (years of education > 6 years) group ≤ 24 points]. Conscious, stable physical condition and signed informed consent of patient. 

排除标准:

1、已确诊有精神系统疾病的患者;2、不能配合完成认知训练有听觉或视觉障碍的患者;3、孕妇和哺乳期妇女(因为不能确定针刺对胎儿和妇女的影响故排除);4、有出血倾向或有血液系统疾病的患者(因为针刺会刺破皮肤,造成出血不能及时止血,故排除);5、严重心血管系统、肝脏、肾脏疾患或其他严重疾病的患者;6、已参加过别的认知训练可能影响实验结果的患者。 

Exclusion criteria:

Pre-existing psychological disorders will be excluded; severe visual and/or hearing problems (impede the operation of cognitive training); Inability to follow instructions (impede cognitive training or assessment); Pregnant and lactating women (it is still unclear whether acupuncture will lead to abortion or other side effects); Bleeding disorder (the acupuncture procedure involves penetration of the skin, therefore we will exclude participants with thrombocytopenia, and so on); Serious illnesses of the heart, liver, or kidney, or other severe diseases (there may be risks that acupuncture induces stress action and thus harms patients with serious illness); Participating in other clinical trials that would affect the evaluation results of this study. 

研究实施时间:

Study execute time:

From2018-12-01To 2019-03-31 

干预措施:

Interventions:

组别:

基础康复治疗

样本量:

70

Group:

G1

Sample size:

干预措施:

仅进行物理康复治疗

干预措施代码:

Intervention:

physiotherapy only

Intervention code:

组别:

基础康复治疗+针刺治疗

样本量:

70

Group:

G2

Sample size:

干预措施:

物理治疗和针刺治疗

干预措施代码:

Intervention:

physiotherapy and acupuncture

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川省八一康复中心(四川省康复医院) 

单位级别:

三级甲等 

Institution
hospital:

Sichuan Bayi Rehabilitation Center (Sichuan Provincial Rehabilitational Hospital)  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

成都中西医结合医院 

单位级别:

三级甲等 

Institution
hospital:

Chengdu Integrated TCM & Western Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

MMSE评定量表

指标类型:

主要指标 

Outcome:

MMSE scale

Type:

Primary indicator 

指标中文名:

p300脑电图

指标类型:

主要指标 

Outcome:

p300 electroencephalogram

Type:

Primary indicator 

采集人体标本:

Collecting sample(s)
from participants:

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 0 years
最大 Max age 0 years

随机方法(请说明由何人用什么方法产生随机序列):

随机分配序列由一名独立统计学家使用统计学软件SAS9.1PLAN句子编辑生成,该统计学家来自于四川大学华西医学院循证医学中心,不参与该实验研究。符合纳入标准的患者通过随机和盲法分配到4个研究组(G1,G2,G3,G4),确保每一例患者分配到4个组的几率一致。随机分组的序列号有专门指定的一名助教负责保管隐藏,所有研究人员在最后结果完成后才能知晓相关结果。分配到有针灸治疗的针灸治疗师将被直接告知分配的组别。所有患者在分配好组别后均会被告知所分组别名称和相关干预措施。

性别:

男女均可

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

The random allocation sequence will be produced by an independent statistician via the PLAN sentences of the statistical software SAS9.1, who works in the Evidence- Based Center of the Sichuan University and is not involved in the study. The eligible patients will be randomly and blindly allocated to the

Gender:

Both

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):

文章发表后一年

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

report published with one year

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):

电子病例记录表

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

Case Record Form, CRF

创建人:

Creater Name:

 2018-11-16
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