三维姿势矫正联合感觉运动训练对轻中度青少年特发性脊柱侧弯功能的影响

注册号:

Registration number:

ChiCTR2500114581 

最近更新日期:

Date of Last Refreshed on:

2025-12-15 12:02:05 

注册时间:

Date of Registration:

2025-12-15 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

三维姿势矫正联合感觉运动训练对轻中度青少年特发性脊柱侧弯功能的影响

Public title:

Three-Dimensional Postural Correction Combined with Sensorimotor Training on Functional Improvement in Adolescents with Mild to Moderate Idiopathic Scoliosis

注册题目简写:

English Acronym:

研究课题的正式科学名称:

三维姿势矫正联合感觉运动训练对轻中度青少年特发性脊柱侧弯功能的影响

Scientific title:

Three-Dimensional Postural Correction Combined with Sensorimotor Training on Functional Improvement in Adolescents with Mild to Moderate Idiopathic Scoliosis

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:

王丽媛 

研究负责人:

刘华;王丽媛 

Applicant:

Liyuan Wang 

Study leader:

Hua Liu; Liyuan Wang 

申请注册联系人电话:

Applicant telephone:

+86 156 1560 2829

研究负责人电话:

Study leader's
telephone:

+86 10 8209 9064

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:

24008021024@cupes.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

liuhua@cupes.edu.cn

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:

北京市海淀区北三环西路11号

研究负责人通讯地址:

北京市海淀区北三环西路11号

Applicant address:

No. 11, West Beisanhuan Road, Haidian District, Beijing

Study leader's address:

No. 11, West Beisanhuan Road, Haidian District, Beijing

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:

首都体育学院

Applicant's institution:

Capital University of Physical Education and Sports

研究负责人所在单位:

首都体育学院

Affiliation of the Leader:

Capital University of Physical Education and Sports

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2025A146

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:

首都体育学院学术委员会伦理道德专门委员会

Name of the ethic committee:

Ethics and Ethics Committee of Capital Sports Institute

伦理委员会批准日期:

Date of approved by ethic committee:

2025-11-12 00:00:00

伦理委员会联系人:

付全

Contact Name of the ethic committee:

Fu Quan

伦理委员会联系地址:

北京市海淀区北三环西路11号

Contact Address of the ethic committee:

Capital University of Physical Education And Sports

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10 8209 9157

伦理委员会联系人邮箱:

Contact email of the ethic committee:

fuquan@cupes.edu.cn

研究实施负责(组长)单位:

首都体育学院

Primary sponsor:

Capital University of Physical Education And Sports

研究实施负责(组长)单位地址:

北京市海淀区北三环西路11号

Primary sponsor's address:

No. 11, North Third Ring Road West, Haidian District, Beijing

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):

海淀

Country:

China

Province:

Beijing

City:

Haidian

单位(医院):

首都体育学院

具体地址:

北京市海淀区北三环西路11号首都体育学院

Institution
hospital:

Capital University of Physical Education And Sports

Address:

Capital Institute of Physical Education, 11 Beisanhuan West Road, Haidian District, Beijing

经费或物资来源:

北京社科基金项目(编号:24YTB018):基于ICF框架青少年脊柱健康评估体系构建与实证研究

Source(s) of funding:

Beijing Social Science Foundation Project (No. :24YTB018): Construction and empirical study of adolescent spinal health assessment system based on ICF framework

研究疾病:

青少年特发性脊柱侧弯  

Target disease:

Adolescent Idiopathic Scoliosis

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:

其它 

Study phase:

N/A

研究设计:

随机平行对照 

Study design:

Parallel 

研究目的:

探讨三维姿势矫正联合感觉运动训练对AIS患者躯干旋转角、静态姿势稳定性、动态平衡、功能性动作筛查、肺活量、肌电、生活质量的疗效,并进一步探讨感觉运动训练对AIS患者的康复效果及潜在机制,为丰富AIS的运动疗法手段,推广感觉运动训练在AIS中的应用提供理论证据。  

Objectives of Study:

To investigate the therapeutic effects of three-dimensional postural correction combined with sensorimotor training on trunk rotation angle, static postural stability, dynamic balance, functional movement screening, vital capacity, electromyography, and quality of life in patients with adolescent idiopathic scoliosis (AIS). Furthermore, to explore the rehabilitation effectiveness and potential mechanisms of sensorimotor training in AIS, thereby providing theoretical evidence for enriching exercise-based interventions for AIS and promoting the application of sensorimotor training in this population.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

(1)有心血管疾病、呼吸系统疾病、急性骨折等运动相关禁忌证者; (2)曾接受过脊柱手术或其他脊柱侧弯保守治疗; (3)存在神经肌肉或前庭系统异常的患者; (4)患者因认知障碍、行为问题或其他原因无法按计划完成评估和康复训练。

Exclusion criteria:

1. Individuals with contraindications to exercise, such as cardiovascular disease, respiratory disorders, or acute fractures; 2. Those who have undergone spinal surgery or received other conservative treatments for scoliosis; 3. Patients with neuromuscular disorders or vestibular system abnormalities; 4. Individuals who are unable to complete the planned assessments or rehabilitation training due to cognitive impairment, behavioral problems, or other limiting factors.

研究实施时间:

Study execute time:

From 2026-03-01 00:00:00 To 2026-07-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-03-01 00:00:00 To 2026-03-20 00:00:00

干预措施:

Interventions:

组别:

试验组1

样本量:

7

Group:

Experimental Group 1

Sample size:

干预措施:

三维姿势矫正训练

干预措施代码:

Intervention:

Three-Dimensional Postural Correction Training

Intervention code:

组别:

试验组2

样本量:

7

Group:

Experimental Group 2

Sample size:

干预措施:

三维姿势矫正训练联合感觉运动训练

干预措施代码:

Intervention:

Three-Dimensional Postural Correction Training Combined with Sensorimotor Training

Intervention code:

组别:

对照组

样本量:

7

Group:

control group

Sample size:

干预措施:

健康教育

干预措施代码:

Intervention:

Health education

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):

首都体育学院  

单位级别:

大学  

Institution
hospital:

Capital University of Physical Education And Sports

Level of the institution:

Capital University of Physical Education And Sports

测量指标:

Outcomes:

指标中文名:

躯干旋转角度

指标类型:

主要指标

Outcome:

trunk rotation angle

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

静态姿势稳定性

指标类型:

主要指标

Outcome:

Static postural stability

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

动态平衡能力

指标类型:

主要指标

Outcome:

Dynamic balance ability

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

表面肌电

指标类型:

主要指标

Outcome:

surface electromyography

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺活量

指标类型:

主要指标

Outcome:

vital capacity

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

功能性动作筛查

指标类型:

次要指标

Outcome:

Functional Movement Screen

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量

指标类型:

次要指标

Outcome:

quality of life

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体力活动

指标类型:

次要指标

Outcome:

physical activity

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:

标本中文名:

组织:

Sample Name:

None

Tissue:

人体标本去向

其它  

说明

Fate of sample:

0thers  

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 10 years
最大 Max age 18 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):

随机数法:电脑生成随机数分组

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

Random number method:Computer generated random number grouping.

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:

单盲:受试者不知道自己属于哪个分组。

Blinding:

Single blind:The subjects did not know which group they belonged to.

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):

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

None

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:

利用各项仪器进行测试获取数据,记录在excel表中,在excel表中进行数据的管理。

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

Use various instruments to test and obtain data, record in Excel, and manage the data in Excel.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2025-12-15 12:01:48