今天是:2020-08-11 星期二

针灸促进中风后足内翻康复的生物力学机制研究
下载XML文档

注册号:

Registration number:

ChiCTR-IPC-15006889 

最近更新日期:

Date of Last Refreshed on:

2015-08-06 

注册时间:

Date of Registration:

2015-08-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

针灸促进中风后足内翻康复的生物力学机制研究 

Public title:

The biomechanical effect of acupuncture for post-stroke strephenopodia 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于RSSCAN步态系统探讨针刺促进中风后足内翻康复的生物力学效应机制研究 

Scientific title:

A study of the biomechanical effect of acupuncture for post-stroke strephenopodia base on the RSSCAN gait system 

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:

张勇 

研究负责人:

张勇 

Applicant:

Yong Zhang 

Study leader:

Yong Zhang 

申请注册联系人电话:

Applicant telephone:

+86 13601229422 

研究负责人电话:

Study leader's telephone:

+86 13601229422 

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:

zhangyong_tcm@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangyong_tcm@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.dzmhospital.com 

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:

北京市东城区海运仓5号东直门医院康复科 

研究负责人通讯地址:

北京市东城区海运仓5号东直门医院康复科 

Applicant address:

5 Haiyuncang, Dongcheng District, Beijing, China 

Study leader's address:

5 Haiyuncang, Dongcheng District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100700 

研究负责人邮政编码:

Study leader's postcode:

100700 

申请人所在单位:

北京中医药大学东直门医院 

Applicant's institution:

Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine 

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:

ECPJ-BDY-2015-25 

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:

北京中医药大学东直门医院医学伦理委员会 

Name of the ethic committee:

IRB of Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-07-20 

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:

北京中医药大学东直门医院 

Primary sponsor:

Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine 

研究实施负责(组长)单位地址:

北京市东城区海运仓5号东直门医院康复科 

Primary sponsor's address:

5 Haiyuncang, Dongcheng District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医药大学东直门医院

具体地址:

北京市东城区海运仓5号

Institution
hospital:

Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine

Address:

5 Haiyuncang, Dongcheng District, Beijing, China

经费或物资来源:

北京中医药大学校级课题科研立项支持 

Source(s) of funding:

Funded by Beijing University of Chinese Medicine 

研究疾病:

中风病 

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:

探索性研究/预试验 

Study phase:

研究目的:

应用RSSCAN步态系统探讨针灸促进中风后足内翻康复的生物力学效应机制 

Objectives of Study:

To study of the biomechanical effect of acupuncture for post-stroke strephenopodia base on the RSSCAN gait system 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

1.符合现代医学缺血性中风的诊断标准,并由CT或MRI检查证实; 2.性别男女均可,年轻在35-75岁之间; 3.首次发病或虽既往有中风病史但未遗留神经功能障碍(mRS≤2分); 4.中风病发病后生命体征平稳开始至发病6个月以内的患者; 5.本次发病具有足内翻症状,且能够独立行走6米以上; 6.患者血压稳定在160/100mmHg以下; 7.能够配合课题研究,简易智能精神状态检查MMSE≥24分; 8.患者本人或其监护人同意参加研究并签署知情同意书 

Inclusion criteria

1. confirmed stroke patients with CT or MRI results; 2. adults between 35 and 70 years old; 3. first episode of stroke or recurrent stroke without neuro-functional disablility; 4. stable condition after stroke and within 6 months of the onset; 5. with unilateral lower limb strephenopodia and could walk at least 6 meters; 6. blood pressure lower than 160/100 mmHg; 7. sufficient cognition to follow commands, Mini-Mental State Examination (MMSE) score > 24; 8. the informed consent form signed. 

排除标准:

1.符合脑梗死诊断标准,但经过溶栓或手术治疗的患者; 2.符合脑梗死诊断标准,但发病超过半年的患者; 3.蛛网膜下腔出血、脑出血、TIA、脑肿瘤、脑外伤等不符合诊断的患者; 4.本次发病没有足内翻症状,或有足内翻症状但不能行走6米以上; 5.中风后病情不稳定或病情趋于恶化及出现新的梗死或出血的患者; 6.合并有腰椎病、膝骨关节病变、足部病变等其他能够影响患者行走步态的疾病; 7.合并有严重的心、肺、肝、肾等重要脏器及血液系统功能异常的患者; 8.妊娠或哺乳期的妇女; 8.正在参加其他临床研究的患者。 

Exclusion criteria:

1. received thrombolytic therapy or surgery; 2. stroke beyong 6 months after the onset; 3. other kind of stroke; 4. stroke without strephenopodia or with but could not walk 6 miters; 5. vital signs are not stable or with worsen conditions; 6. osteoarticular diseases of lower limbs, the foot, or the lumbar that would affect gait posture; 7. severe primary diseases of the cardiovascular system, liver, kidney, or hematopoietic system; 8. pregnant or lactating women; 9. participating in other clinical trials. 

研究实施时间:

Study execute time:

From2015-05-01To 2016-04-30 

征募观察对象时间:

Recruiting time:

From2015-09-01To 2016-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

treatment group

Sample size:

干预措施:

针灸

干预措施代码:

Intervention:

acupuncture

Intervention code:

组别:

试验组

样本量:

30

Group:

treatment group

Sample size:

干预措施:

现代康复

干预措施代码:

Intervention:

conventional rehabilitation programs

Intervention code:

组别:

对照组

样本量:

30

Group:

control group

Sample size:

干预措施:

现代康复

干预措施代码:

Intervention:

conventional rehabilitation programs

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医药大学东直门医院 

单位级别:

三甲医院 

Institution
hospital:

Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

足底压力冲量变化

指标类型:

主要指标 

Outcome:

dynamic plantar pressure distribution

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

足底压力分布

指标类型:

主要指标 

Outcome:

static plantar contact area

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

行走时相

指标类型:

次要指标 

Outcome:

time of walk phase

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Berg平衡量表

指标类型:

次要指标 

Outcome:

Berg Balance 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:

FMA量表

指标类型:

次要指标 

Outcome:

Fugl-Meyer Assessment

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SSQOL脑卒中生活质量量表

指标类型:

次要指标 

Outcome:

Stroke-Specific Quality of Life 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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 35 years
最大 Max age 75 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):

课题负责人随机数字表法制作随机信封

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

Random envelope designed by investigitor

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/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:

 2015-08-06
返回列表