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多模式镜像VR康复对脑卒中认知 与上肢运动及脑功能的机制研究
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注册号:

Registration number:

ChiCTR1900027987 

最近更新日期:

Date of Last Refreshed on:

2019-12-07 

注册时间:

Date of Registration:

2019-12-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

多模式镜像VR康复对脑卒中认知 与上肢运动及脑功能的机制研究 

Public title:

The mechanism of cognition, upper extremity and brain function of stroke rehabilitation via multimodal mirror VR. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

多模式镜像VR康复对脑卒中认知 与上肢运动及脑功能的机制研究 

Scientific title:

The mechanism of cognition, upper extremity and brain function of stroke rehabilitation via multimodal mirror VR. 

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:

张益慧 

研究负责人:

蒋松鹤 

Applicant:

Yihui Zhang 

Study leader:

Songhe Jiang 

申请注册联系人电话:

Applicant telephone:

+86 15258638622 

研究负责人电话:

Study leader's telephone:

+86 13600661860 

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:

313908069@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

863191168@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:

浙江省温州市鹿城区学院西路109号温州医科大学附属第二医院 

研究负责人通讯地址:

浙江省温州市鹿城区学院西路109号温州医科大学附属第二医院 

Applicant address:

109 Xueyuan Road West, Lucheng District, Wenzhou, Zhejiang, China 

Study leader's address:

109 Xueyuan Road West, Lucheng District, Wenzhou, Zhejiang, 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:

温州医科大学附属第二医院 

Applicant's institution:

The Second Affiliated Hospital of Wenzhou Medical 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:

LCKY2019-167 

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:

温州医科大学附属第二医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of the Second Affiliated Hospital of Wenzhou Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-06-05 

伦理委员会联系人:

朱雪琼 

Contact Name of the ethic committee:

Xueqiong Zhu 

伦理委员会联系地址:

浙江省温州市鹿城区学院西路109号温州医科大学附属第二医院 

Contact Address of the ethic committee:

The Second Affiliated Hospital of Wenzhou Medical University, 109 Xueyuan Road West, Lucheng District, Wenzhou, Zhejiang, China 

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:

温州医科大学附属第二医院 

Primary sponsor:

The Second Affiliated Hospital of Wenzhou Medical University 

研究实施负责(组长)单位地址:

浙江省温州市鹿城区学院西路109号温州医科大学附属第二医院 

Primary sponsor's address:

109 Xueyuan Road West, Lucheng District, Wenzhou, Zhejiang, 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):

浙江

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

温州医科大学附属第二医院

具体地址:

浙江省温州市鹿城区学院西路109号温州医科大学附属第二医院

Institution
hospital:

The Second Affiliated Hospital of Wenzhou Medical University

Address:

109 Xueyuan Road West, Lucheng District, Wenzhou

经费或物资来源:

温州医科大学附属第二医院、育英儿童医院杨观虎教授外专人才启动经费 

Source(s) of funding:

The fund for foreign talents of Professor Yang Guanhu of the Second Affiliated Hospital of Wenzhou Medical University and Yuying children's Hospital  

研究疾病:

脑卒中 

Target disease:

stroke 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

探讨针对脑卒中患者的镜像运动的多模式镜像VR对脑卒中认知与上肢运动及脑功能的机制研究 

Objectives of Study:

To explore the mechanism of stroke rehabilitation of cognition, upper extremity and brain function.  

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:

针对认知功能的研究: (1)年龄18-70岁; (2)首次卒中且在3个月内; (3)生命体征稳定; (4)无空间幽闭综合征 针对上肢功能的研究: (1)年龄18-70岁; (2)首次卒中且在3个月内; (3)生命体征稳定; (4)MMSE大于等于15分的认知能力; (5)Brunnstrom II及IV期  

Inclusion criteria

Research on cognitive function: 1. aged 18-70 years; 2. First stroke within 3 months; 3. Stable vital signs; 4. No space claustrophobia syndrome. Research on upper limb function: 1. aged 18-70 years; 2. First stroke within 3 months; 3. Stable vital signs; 4. Cognitive ability with MMSE >=15 points; 5. Brunnstrom stage II and IV. 

排除标准:

针对认知功能的研究: (1)有视觉障碍患者; (2)具有过敏、出血、哮喘、美尼尔综合征或耳石症等不适合VR设备疾病的患者; (3)有语言或听觉障碍患者; (4)因各种原因不愿配合的患者 针对上肢功能的研究: (1)有视觉、语言或听觉障碍患者; (2)有过敏、出血、帕金森、阿尔兹海默症、骨折等不适合VR设备疾病的患者; (3)重要脏器功能减退或衰竭; (4)因各种原因不愿配合的患者 

Exclusion criteria:

Research on cognitive function: 1. patients with visual impairment; 2. Patients with allergies, bleeding, asthma, Meniere's syndrome or otolith that are not suitable for VR device diseases; 3. Patients with language or hearing impairment; 4. Patients who are unwilling to cooperate for various reasons. Research on upper limb function: 1. patients with vision, language or hearing impairment; 2. patients with allergies, bleeding, Parkinson's disease, Alzheimer's disease, fracture and other diseases not suitable for VR equipment; 3. patients with important organ dysfunction or failure; 4. patients who are unwilling to cooperate due to various reasons. 

研究实施时间:

Study execute time:

From2019-12-20To 2021-06-20 

征募观察对象时间:

Recruiting time:

From2019-12-20To 2021-06-20 

干预措施:

Interventions:

组别:

实验组

样本量:

60

Group:

Experimental group

Sample size:

干预措施:

传统康复+多模式镜像VR

干预措施代码:

Intervention:

Conventional rehabilitation + Multimode mirror VR

Intervention code:

组别:

对照组

样本量:

60

Group:

Control group

Sample size:

干预措施:

传统康复+假VR康复训练

干预措施代码:

Intervention:

Conventional rehabilitation + Sham multimode mirror VR

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

温州医科大学附属第二医院 

单位级别:

三甲医院 

Institution
hospital:

The Second Affiliated Hospital of Wenzhou Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

功能磁共振

指标类型:

主要指标 

Outcome:

Functional magnetic resonance

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

近红外成像

指标类型:

主要指标 

Outcome:

Near infrared imaging

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:

标本中文名:

组织:

Sample Name:

None

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

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

首诊医师采用随机数字表法进行分组

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

The first doctors group patients by random number table

盲法:

单盲

Blinding:

Single blind

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):

不公开

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

Not public

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:

Redcap

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

Redcap

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-12-07
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