ChiCTR2100054320 版本V1.0 版本创建时间2022/11/11 10:33:44 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2100054320 

最近更新日期：

Date of Last Refreshed on：

 2021-12-13 10:12:46 

注册时间：

Date of Registration：

 2021-12-13 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Hong-Ji Luo：此为补注册，需在www.medresman.org上建立项目、审核原始数据并公示后才能补注册 比較改良壓力生物回饋裝置對青少年特發性脊柱側凸和非特發性脊柱側凸節段性脊柱運動控制

Public title：

Comparison of adolescent idiopathic scoliosis and healthy adolescent on spinal motor control difference.

注册题目简写：

English Acronym：

Spinal movement control in AIS

研究课题的正式科学名称：

比較改良壓力生物回饋裝置對青少年特發性脊柱側凸和非特發性脊柱側凸節段性脊柱運動控制

Scientific title：

Comparison of Segmental Spinal Movement Control in Adolescents with and without Idiopathic Scoliosis Using Modified Pressure Biofeedback Unit

研究课题代号(代码)：

Study subject ID：

 YM105010F

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：

Hong-Ji Luo 

研究负责人：

Hong-Ji Luo 

Applicant：

Hong-Ji Luo 

Study leader：

Hong-Ji Luo 

申请注册联系人电话：

Applicant telephone：

 +886 228267946

研究负责人电话：

Study leader's
telephone：

+886 228267946

申请注册联系人传真 ：

Applicant Fax：

 +886 228201841

研究负责人传真：

Study leader's fax：

 +886 228201841

申请注册联系人电子邮件：

Applicant E-mail：

 hjluo@nycu.edu.tw

研究负责人电子邮件：

Study leader's E-mail：

 hjluo@nycu.edu.tw

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：

中國臺灣省臺北市北投區立農街2段155號

研究负责人通讯地址：

中國臺灣省臺北市北投區立農街2段155號

Applicant address：

No.155, Sec.2, Linong Street, Taipei, 112 Taiwan, China

Study leader's address：

No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)

申请注册联系人邮政编码：

Applicant postcode：

 112

研究负责人邮政编码：

Study leader's postcode：

 112

申请人所在单位：

國立陽明交通大學物理治療暨輔助科技學系

Applicant's institution：

Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University

研究负责人所在单位：

國立陽明交通大學物理治療暨輔助科技學系

Affiliation of the Leader：

Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung 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：

 YM105010F

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：

國立陽明大學機構倫理委員會

Name of the ethic committee：

Institutional Review Board (IRB) of National Yang Ming University

伦理委员会批准日期：

Date of approved by ethic committee：

 2016-04-18 00:00:00

伦理委员会联系人：

國立陽明大學機構倫理委員會

Contact Name of the ethic committee：

Institutional Review Board (IRB)

伦理委员会联系地址：

中國臺灣省臺北市北投區立農街2段155號

Contact Address of the ethic committee：

No.155, Sec.2, Linong Street, Taipei, 112 Taiwan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +886 228239753

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 irb@ym.edu.tw

研究实施负责（组长）单位：

Self-financed study (by primary investigator)

Primary sponsor：

Self-financed study (by primary investigator)

研究实施负责（组长）单位地址：

中國臺灣省臺北市北投區立農街2段155號

Primary sponsor's address：

No.155, Sec.2, Linong Street, Taipei, 112 Taiwan, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

未说明

省(直辖市)：

未说明

市(区县)：

Country：

Not stated

Province：

Not stated

City：

单位(医院)：

未说明

具体地址：

未说明

Institution
hospital：

Not stated

Address：

Not stated

经费或物资来源：

Self-financed study (by primary investigator)

Source(s) of funding：

Self-financed study (by primary investigator)

研究疾病：

特發性脊柱側凸  

Target disease：

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

析因分组（即根据危险因素或暴露因素分组） 

Study design：

Factorial 

研究目的：

The purpose of this study was to compare the differences in local cervical, thoracic and lumbar motor control performance between adolescents with idiopathic scoliosis and healthy adolescents.  

Objectives of Study：

The purpose of this study was to compare the differences in local cervical, thoracic and lumbar motor control performance between adolescents with idiopathic scoliosis and healthy adolescents.

药物成份或治疗方案详述：

The researchers collected the basic information of each subject and then carried out the evaluation of the local cervical, thoracic and lumbar motor control test. The measuring instrument used in this study was the pressure biofeedback unit that was linked to a screen of displaying pressure value and to a personal laptop to record pressure data during the testing process. The local cervical, thoracic and lumbar motor control test was divided into the neck, chest and waist tests. Variables examined in this study included parameters of pressure value (the amount of deviation, the amplitude of fluctuation) and time (the percentage of time within the target pressure range, the time point of began to appear outside the target pressure range). 

Description for medicine or protocol of treatment in detail：

The researchers collected the basic information of each subject and then carried out the evaluation of the local cervical, thoracic and lumbar motor control test. The measuring instrument used in this study was the pressure biofeedback unit that was linked to a screen of displaying pressure value and to a personal laptop to record pressure data during the testing process. The local cervical, thoracic and lumbar motor control test was divided into the neck, chest and waist tests. Variables examined in this study included parameters of pressure value (the amount of deviation, the amplitude of fluctuation) and time (the percentage of time within the target pressure range, the time point of began to appear outside the target pressure range). 

纳入标准：

Idiopathic scoliosis group:
1) be diagnosed with adolescent idiopathic scoliosis;
2) cobb angle between 10 to 45 degrees;
3) aged between 10 to 18 year-old.

Healthy adolescent group:
1) aged between 10 to 18 year-old.

Inclusion criteria

Idiopathic scoliosis group:
1) be diagnosed with adolescent idiopathic scoliosis;
2) cobb angle between 10 to 45 degrees;
3) aged between 10 to 18 year-old.

Healthy adolescent group:
1) aged between 10 to 18 year-old.

排除标准：

Idiopathic scoliosis group: the participants:
1) can not understand and follow verbal cue;
2) have numbness, weakness or dysesthesia;
3) received spine surgery at past year;
4) have other diseases or chronic disease would affect physical performance;
5) have leg length discrepancy (>1cm).

Healthy adolescent group: the participants:
1) can not understand and follow verbal cues;
2) have diseases of orthopedics, like scoliosis;
3) have numbness, weakness or dysesthesia;
4) have other diseases or chronic disease would affect physical performance;
5) have leg length discrepancy (>1cm).

Exclusion criteria：

Idiopathic scoliosis group: the participants:
1) can not understand and follow verbal cue;
2) have numbness, weakness or dysesthesia;
3) received spine surgery at past year;
4) have other diseases or chronic disease would affect physical performance;
5) have leg length discrepancy (>1cm).

Healthy adolescent group: the participants:
1) can not understand and follow verbal cues;
2) have diseases of orthopedics, like scoliosis;
3) have numbness, weakness or dysesthesia;
4) have other diseases or chronic disease would affect physical performance;
5) have leg length discrepancy (>1cm).

研究实施时间：

Study execute time：

从 From 2016-04-18 00:00:00至 To 2017-03-29 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2016-04-18 00:00:00 至 To 2017-03-29 00:00:00

干预措施：

Interventions：

组别：

特发性脊柱侧凸与健康青少年

样本量：

 40

Group：

idiopathic scoliosis and healthy adolescents

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 臺灣 

市(区县)：

 臺北 

Country：

China

Province：

Taiwan

City：

Taipei

单位(医院)：

 國立陽明交通大學 

单位级别：

 大學 

Institution
hospital：

National Yang-Ming University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

颈部、胸部和腰椎运动控制性能

指标类型：

主要指标

Outcome：

Cervical, thoracic and lumbar motor control performance

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 10 岁 years
最大 Max age 17 岁 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）：

No

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

This study was cross-section observational study (not a randomized clinical trial).

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

N/A

Blinding：

N/A

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）：

No

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

Not applicable

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：

N/A

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

Not applicable

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-12-13 10:12:46