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青少年特发性脊柱侧凸患者矫形器穿戴时间与人格特征的相关性
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注册号:

Registration number:

ChiCTR2000034658 

最近更新日期:

Date of Last Refreshed on:

2020-07-14 

注册时间:

Date of Registration:

2020-07-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

青少年特发性脊柱侧凸患者矫形器穿戴时间与人格特征的相关性 

Public title:

Correlation between orthosis wearing time and personality characteristics in adolescent idiopathic scoliosis patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

青少年特发性脊柱侧凸患者矫形器穿戴时间与个性特征的相关性研究 

Scientific title:

Correlation between orthosis wearing time and personality characteristics in adolescent idiopathic scoliosis patients 

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:

郑倩 

研究负责人:

许涛 

Applicant:

Qian Zheng 

Study leader:

Tao Xu 

申请注册联系人电话:

Applicant telephone:

+86 18694040735 

研究负责人电话:

Study leader's telephone:

+86 13507129858 

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:

1355372846@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

rehabcc@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:

中国湖北省武汉市硚口区解放大道1095号 

研究负责人通讯地址:

中国湖北省武汉市硚口区解放大道1095号 

Applicant address:

1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei, China 

Study leader's address:

1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei, 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:

430030 

申请人所在单位:

华中科技大学同济医学院附属同济医院康复医学科 

Applicant's institution:

Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095#, Jiefang Avenue,Qiaokou District, Wuhan 430030, Hubei, China 

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:

TJ-IRB20191003 

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:

华中科技大学同济医学院附属同济医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-10-25 

伦理委员会联系人:

杜艾桦 

Contact Name of the ethic committee:

Aihua Du 

伦理委员会联系地址:

中国湖北省武汉市硚口区解放大道1095号华中科技大学同济医学院附属同济医院科研处 

Contact Address of the ethic committee:

Research Department, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Qiaokou District,Wuhan, Hubei, 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:

华中科技大学同济医学院附属同济医院康复医学科 

Primary sponsor:

Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology 

研究实施负责(组长)单位地址:

中国湖北省武汉市硚口区解放大道1095号 

Primary sponsor's address:

1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei, 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):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

华中科技大学同济医学院附属同济医院

具体地址:

硚口区解放大道1095号

Institution
hospital:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address:

1095 Jiefang Avenue, Qiaokou District

经费或物资来源:

无 

Source(s) of funding:

No 

研究疾病:

青少年特发性脊柱侧凸 

Target disease:

Adolescent idiopathic scoliosis  

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:

青少年特发性脊柱侧凸患者矫形器穿戴时间与个性特征的相关性研究。 

Objectives of Study:

Correlation between orthosis wearing time and personality characteristics in adolescent idiopathic scoliosis patients. 

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)符合SOSORT矫形器治疗纳入标准 ① 年龄10-16岁; ② 诊断为特发性脊柱侧凸,Cobb角度为20-45°; ③ Risser佂 0-2度; ④ 女性患者需是月经初潮之前或者月经初潮后一年以内; ⑤ 未接受过相关治疗。 (2)接受矫形器治疗; (3)配合定期复查随访; (4)坚持治疗至少1年。 

Inclusion criteria

1. Meet the SOSORT orthotics treatment inclusion criteria (1) Aged 10-16 years; (2) Diagnosed as idiopathic scoliosis, Cobb angle is 20-45°; (3) Risser sign 0-2 degrees; (4) Female patients must be before menstruation or within one year after menstruation; (5) Have not received relevant treatment. 2. Receive orthotic treatment; 3. Cooperate with regular review and follow-up; 4. Adhere to treatment for at least 1 year. 

排除标准:

(1)近期有骨骼肌肉系统损伤者; (2)心肺系统疾患者; (3)认知、精神疾患者。 

Exclusion criteria:

1. Those with recent skeletal and muscular system injuries; 2. Patients with cardiopulmonary diseases; 3. Patients with cognitive and mental disorders. 

研究实施时间:

Study execute time:

From2020-08-01To 2022-12-31 

征募观察对象时间:

Recruiting time:

From2020-08-01To 2022-12-31 

干预措施:

Interventions:

组别:

case series

样本量:

85

Group:

case series

Sample size:

干预措施:

矫形器治疗

干预措施代码:

Intervention:

Orthosis treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

华中科技大学同济医学院附属同济医院 

单位级别:

三级甲等 

Institution
hospital:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

艾森克个性问卷评估

指标类型:

主要指标 

Outcome:

Eysenck personality questionnaire evaluation

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:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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):

不适用

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

N/A

盲法:

N/A

Blinding:

N/A

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:

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):

暂无

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

Temporarily not available

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:

病例记录表、电子采集和管理系统

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

Case Record Form, CRF; 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:

 2020-07-13
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