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龙氏日常生活活动能力量表推广应用研究
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注册号:

Registration number:

ChiCTR2000034067 

最近更新日期:

Date of Last Refreshed on:

2020-06-28 

注册时间:

Date of Registration:

2020-06-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

龙氏日常生活活动能力量表推广应用研究 

Public title:

Research on the popularization and Application of Longshi Scale of Activities of Daily Living 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

龙氏日常生活活动能力量表推广应用研究 

Scientific title:

Research on the popularization and Application of Longshi Scale of Activities of Daily Living 

研究课题代号(代码):

Study subject ID:

深圳“三名工程”(SZSM201610039) 

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:

周静 

研究负责人:

王玉龙 

Applicant:

Jing Zhou 

Study leader:

Yulong Wang 

申请注册联系人电话:

Applicant telephone:

+86 15618230670 

研究负责人电话:

Study leader's telephone:

+86 13923448395 

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:

286980558@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

ylwang66@126.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:

中国广东省深圳市福田区笋岗西路3002号 

研究负责人通讯地址:

中国广东省深圳市福田区笋岗西路3002号 

Applicant address:

3002 Sungang Road, Futian District, Shenzhen, Guangdong, China 

Study leader's address:

3002 Sungang Road, Futian District, Shenzhen, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

518035 

研究负责人邮政编码:

Study leader's postcode:

518035 

申请人所在单位:

深圳市第二人民医院,深圳大学第一附属医院 

Applicant's institution:

Shenzhen Second People's Hospital, the First Affiliated Hospital of Shenzhen 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:

20180926006 

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:

深圳市第二人民医院医学伦理委员会 

Name of the ethic committee:

The medical ethics committee of Shenzhen People' Hospital (Shenzhen, China) 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-10-08 

伦理委员会联系人:

陈旭红 

Contact Name of the ethic committee:

Xuhong Chen 

伦理委员会联系地址:

中国广东省深圳市福田区笋岗西路3002号 

Contact Address of the ethic committee:

3002 Sungang Road, Futian District, Shenzhen, Guangdong, 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:

深圳市第二人民医院,深圳大学第一附属医院 

Primary sponsor:

Shenzhen Second People's Hospital, the First Affiliated Hospital of Shenzhen University 

研究实施负责(组长)单位地址:

中国广东省深圳市福田区笋岗西路3002号 

Primary sponsor's address:

3002 Sungang Road, Futian District, Shenzhen, Guangdong, 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):

广东省

市(区县):

深圳

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

深圳市第二人民医院,深圳大学第一附属医院

具体地址:

中国广东省深圳市福田区笋岗西路3002号,518035

Institution
hospital:

Shenzhen Second People's Hospital, The First Affiliated Hospital, Shenzhen University School of Medicine

Address:

3002 Sungang Road, Futian District

经费或物资来源:

深圳“三名工程”(批准编号: SZSM201610039) 

Source(s) of funding:

Shenzhen ''Sanming Project'' (SZSM201610039) 

研究疾病:

康复科常见疾病 

Target disease:

Common diseases in rehabilitation department 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

探究龙氏ADL量表是否可以在不同地区、不同民族、不同宗教信仰、不同的教育程度的人群中使用?探索影响龙氏ADL量表评定结果的可能因素,如研究对象性别、年龄、地域、民族、宗教、文化程度以及其它反应研究对象基本病情的因素? 

Objectives of Study:

To explore whether the Longshi Activities of Daily Living scale can be used by people in different regions, different ethnic groups, different religious beliefs, and different levels of education.To explore the possible factors that affect the evaluation results of the Longshi ADL scale, such as the gender, age, region, ethnicity, religion, education level of the research subject, and other factors that reflect the basic condition of the research subject. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1.成人组年龄18岁(包括18岁)以上,无论男女。 2.明确诊断为脑梗死、脑出血、脑外伤、脑肿瘤、脊髓损伤、周围神经肌肉疾病等康复科常见疾病。 3.愿意参与研究,并签署书面知情同意书,遵守程序。 

Inclusion criteria

1. Patients over 18 years old (including 18 years old) in adult group, male and female; 2. The patients were definitely diagnosed as cerebral infarction, cerebral hemorrhage, brain injury, brain tumor, spinal cord injury, peripheral neuromuscular disease and other common diseases in rehabilitation department; 3. Patients who are willing to participate in the study and sign a written informed consent and follow the procedure. 

排除标准:

不能签知情同意书,不愿意参与本研究的对象。 

Exclusion criteria:

Those who could not sign informed consent and not willing to participate in this study. 

研究实施时间:

Study execute time:

From2020-08-16To 2021-08-16 

征募观察对象时间:

Recruiting time:

From2020-08-16To 2021-08-16 

干预措施:

Interventions:

组别:

Case series

样本量:

12000

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

深圳 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

深圳市第二人民医院,深圳大学第一附属医院 

单位级别:

三级医院 

Institution
hospital:

Shenzhen Second People's Hospital, The First Affiliated Hospital, Shenzhen University School of Medicine  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

深圳 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

深圳市宝安中医院 

单位级别:

三级医院 

Institution
hospital:

Shenzhen Bao’an Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

深圳 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

东莞虎门医院 

单位级别:

二级医院 

Institution
hospital:

Dongguan Humen hospital  

Level of the institution:

Second Hospital 

测量指标:

Outcomes:

指标中文名:

信度

指标类型:

主要指标 

Outcome:

reliability

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

效度

指标类型:

主要指标 

Outcome:

validity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

评估耗时

指标类型:

主要指标 

Outcome:

Evaluation of time consuming

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 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):

横断面研究,无随机方法

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

Cross-sectional research,no randomization procedure

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

是否共享原始数据:

IPD sharing

否No

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):

病例收集完成后,可以在数据收集系统”康复快线

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

After the case collection is complete, you can view each piece of data in the data collection system

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:

全部数据均通过“康复快经线”电子采集系统采集和管理

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

All data are collected and managed by the "Rehabilitation Express" electronic collection system

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-06-22
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