ChiCTR2500112330 版本V1.0 版本创建时间2025/11/12 16:15:52 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：

 ChiCTR2500112330 

最近更新日期：

Date of Last Refreshed on：

 2025-11-12 16:15:35 

注册时间：

Date of Registration：

 2025-11-12 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

A 24-Week Physiotherapy Scoliosis-Specific Exercise (PSSE) Intervention Versus Standard Care for Reducing Cobb Angle and Improving Paraspinal Muscle Function in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Trial

Public title：

A 24-Week Physiotherapy Scoliosis-Specific Exercise (PSSE) Intervention Versus Standard Care for Reducing Cobb Angle and Improving Paraspinal Muscle Function in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The effectiveness of a 24-week PSSE intervention on cobb angle, and its impact on restoring oxygen dynamics in paraspinal muscles, paraspinal muscle symmetry, angle of trunk rotation, and overall well-being in adolescents with idiopathic scoliosis- a randomized controlled trial

Scientific title：

The effectiveness of a 24-week PSSE intervention on cobb angle, and its impact on restoring oxygen dynamics in paraspinal muscles, paraspinal muscle symmetry, angle of trunk rotation, and overall well-being in adolescents with idiopathic scoliosis- a randomized controlled trial

研究课题代号(代码)：

Study subject ID：

 HSEARS20240521001

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：

Winnie WY Chan 

研究负责人：

Dr. Arnold Wong  

Applicant：

Winnie WY Chan 

Study leader：

Dr. Arnold Wong  

申请注册联系人电话：

Applicant telephone：

 +852 9877 6575

研究负责人电话：

Study leader's
telephone：

+852 2766 6741

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：

 ptwinnie05@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 arnold.wong@polyu.edu.hk

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：

The Hong Kong Polytechnic University

研究负责人通讯地址：

The Hong Kong Polytechnic University, Hong Kong, Hong Kong

Applicant address：

The Hong Kong Polytechnic University

Study leader's address：

The Hong Kong Polytechnic University, Hong Kong, Hong Kong

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：

The Hong Kong Polytechnic University

Applicant's institution：

The Hong Kong Polytechnic University

研究负责人所在单位：

The Hong Kong Polytechnic University

Affiliation of the Leader：

The Hong Kong Polytechnic 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：

 HSEARS20240521001

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：

PolyU Institutional Review Board

Name of the ethic committee：

PolyU Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-09-13 00:00:00

伦理委员会联系人：

Secretary of Institutional Review Board

Contact Name of the ethic committee：

Secretary of Institutional Review Board

伦理委员会联系地址：

The Hong Kong Polytechnic University

Contact Address of the ethic committee：

The Hong Kong Polytechnic University

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2766 6379

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 nstitutional.review.board@polyu.edu.hk

研究实施负责（组长）单位：

The Hong Kong Polytechnic University

Primary sponsor：

The Hong Kong Polytechnic University

研究实施负责（组长）单位地址：

The Hong Kong Polytechnic University, Hong Kong

Primary sponsor's address：

The Hong Kong Polytechnic University, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Hong Kong

Country：

China

Province：

Hong Kong

City：

Hong Kong

单位(医院)：

The Hong Kong Polytechnic University

具体地址：

The Hong Kong Polytechnic University, Hong Kong

Institution
hospital：

The Hong Kong Polytechnic University

Address：

The Hong Kong Polytechnic University, Hong Kong

经费或物资来源：

NA

Source(s) of funding：

NA

研究疾病：

Adolescent idiopathic scoliosis  

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：

This study will investigate a 24-week Physiotherapy Scoliosis-Specific Exercise (PSSE) program for adolescents with idiopathic scoliosis, a condition that causes a curved spine and is often accompanied by imbalances in the paraspinal muscles (the muscles supporting the spine), including their activity and efficiency. While PSSE is a known treatment, its full effect on these underlying muscle problems is not yet fully understood. The main goal of this research is to test how effective the 24-week PSSE program is, compared to standard care alone, at improving the spinal curve (Cobb angle). We will also examine its impact on the paraspinal muscles, specifically how efficiently they use oxygen, their electrical activity measured by surface electromyography (sEMG), their stiffness, and the patient's overall quality of life.  

Objectives of Study：

This study will investigate a 24-week Physiotherapy Scoliosis-Specific Exercise (PSSE) program for adolescents with idiopathic scoliosis, a condition that causes a curved spine and is often accompanied by imbalances in the paraspinal muscles (the muscles supporting the spine), including their activity and efficiency. While PSSE is a known treatment, its full effect on these underlying muscle problems is not yet fully understood. The main goal of this research is to test how effective the 24-week PSSE program is, compared to standard care alone, at improving the spinal curve (Cobb angle). We will also examine its impact on the paraspinal muscles, specifically how efficiently they use oxygen, their electrical activity measured by surface electromyography (sEMG), their stiffness, and the patient's overall quality of life.

药物成份或治疗方案详述：

Participants in this randomized controlled trial will be assigned by chance to one of two groups. One group will receive the 24-week PSSE program in addition to their standard care, which may include observation or bracing. The other group will continue with only standard care and will not perform the PSSE exercises. Assessments will be conducted at the start of the study, immediately after the 24-week program, and again three months later to measure these changes. 

Description for medicine or protocol of treatment in detail：

Participants in this randomized controlled trial will be assigned by chance to one of two groups. One group will receive the 24-week PSSE program in addition to their standard care, which may include observation or bracing. The other group will continue with only standard care and will not perform the PSSE exercises. Assessments will be conducted at the start of the study, immediately after the 24-week program, and again three months later to measure these changes. 

纳入标准：

1. Adolescents aged 10 to 16 years. 2. Diagnosed with right-sided thoracic or thoracolumbar Adolescent Idiopathic Scoliosis (AIS), classified as Lenke types I, II, or III. 3. Have a primary Cobb angle between 10 and 45 degrees. 4. Show skeletal immaturity, indicated by a Risser sign of 0 to 3. 5. Able to read and write in Chinese. 6. Participation is allowed regardless of whether they are currently using a spinal brace

Inclusion criteria

1. Adolescents aged 10 to 16 years. 2. Diagnosed with right-sided thoracic or thoracolumbar Adolescent Idiopathic Scoliosis (AIS), classified as Lenke types I, II, or III. 3. Have a primary Cobb angle between 10 and 45 degrees. 4. Show skeletal immaturity, indicated by a Risser sign of 0 to 3. 5. Able to read and write in Chinese. 6. Participation is allowed regardless of whether they are currently using a spinal brace

排除标准：

1. Diagnosis of a neuromuscular disease (e.g., cerebral palsy, muscular dystrophy) or a congenital spinal disorder. 2. A history of spinal surgery. 3. Have already completed a full course of brace treatment. 4. Any condition or situation that would make it difficult to follow the study procedures and protocol.

Exclusion criteria：

1. Diagnosis of a neuromuscular disease (e.g., cerebral palsy, muscular dystrophy) or a congenital spinal disorder. 2. A history of spinal surgery. 3. Have already completed a full course of brace treatment. 4. Any condition or situation that would make it difficult to follow the study procedures and protocol.

研究实施时间：

Study execute time：

从 From 2024-05-25 00:00:00至 To 2026-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-05-25 00:00:00 至 To 2025-04-04 00:00:00

干预措施：

Interventions：

组别：

PSSE intervention group

样本量：

 35

Group：

PSSE intervention group

Sample size：

干预措施：

Physiotherapy Scoliosis-Specific Exercise (PSSE) Intervention

干预措施代码：

Intervention：

Physiotherapy Scoliosis-Specific Exercise (PSSE) Intervention

Intervention code：

组别：

Control group

样本量：

 35

Group：

Control group

Sample size：

干预措施：

Standard Care (Observation or bracing)

干预措施代码：

Intervention：

Standard Care (Observation or bracing)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

 Hong Kong 

Country：

China

Province：

Hong Kong

City：

Hong Kong

单位(医院)：

 the Hong Kong Polytechnic University 

单位级别：

 University 

Institution
hospital：

the Hong Kong Polytechnic University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Change in Major Cobb Angle

指标类型：

主要指标

Outcome：

Change in Major Cobb Angle

Type：

Primary indicator

测量时间点：

Baseline and 24 weeks

测量方法：

EOS biplanar X-ray images

Measure time point of outcome：

Baseline and 24 weeks

Measure method：

EOS biplanar X-ray images

指标中文名：

Paraspinal Muscle Oxygen Recovery Time Asymmetry (TrAsy)

指标类型：

次要指标

Outcome：

Paraspinal Muscle Oxygen Recovery Time Asymmetry (TrAsy)

Type：

Secondary indicator

测量时间点：

Baseline, 24 weeks, and 32 weeks

测量方法：

The absolute difference (in seconds) in the time it takes for oxygen levels to recover in the back muscles on the two sides of the spine after exercise, measured with a Moxy muscle oximeter. A smaller value means more symmetrical muscle recovery.

Measure time point of outcome：

Baseline, 24 weeks, and 32 weeks

Measure method：

The absolute difference (in seconds) in the time it takes for oxygen levels to recover in the back muscles on the two sides of the spine after exercise, measured with a Moxy muscle oximeter. A smaller value means more symmetrical muscle recovery.

指标中文名：

Absolute Muscle Asymmetry Ratio (AMAR) of Muscle Stiffness

指标类型：

次要指标

Outcome：

Absolute Muscle Asymmetry Ratio (AMAR) of Muscle Stiffness

Type：

Secondary indicator

测量时间点：

Baseline, 24 weeks, and 32 weeks

测量方法：

The absolute difference in stiffness (in Newtons per meter) between the back muscles on the two sides of the spine at rest, measured with a MyotonPRO device. A smaller value indicates more symmetrical muscle stiffness.

Measure time point of outcome：

Baseline, 24 weeks, and 32 weeks

Measure method：

The absolute difference in stiffness (in Newtons per meter) between the back muscles on the two sides of the spine at rest, measured with a MyotonPRO device. A smaller value indicates more symmetrical muscle stiffness.

指标中文名：

Angle of Trunk Rotation (ATR)

指标类型：

次要指标

Outcome：

Angle of Trunk Rotation (ATR)

Type：

Secondary indicator

测量时间点：

Baseline, 24 weeks, and 32 weeks

测量方法：

The angle (in degrees) of trunk rotation measured at the most rotated part of the spine using a scoliometer during a forward bend test. A lower value indicates less trunk deformity.

Measure time point of outcome：

Baseline, 24 weeks, and 32 weeks

Measure method：

The angle (in degrees) of trunk rotation measured at the most rotated part of the spine using a scoliometer during a forward bend test. A lower value indicates less trunk deformity.

指标中文名：

Scoliosis Research Society-22r (SRS-22r) Questionnaire Score

指标类型：

次要指标

Outcome：

Scoliosis Research Society-22r (SRS-22r) Questionnaire Score

Type：

Secondary indicator

测量时间点：

Baseline, 24 weeks, and 32 weeks

测量方法：

A 22-item questionnaire measuring quality of life related to scoliosis, covering function, pain, self-image, mental health, and satisfaction. Scores range from 1 to 5 per domain, with a higher score indicating a better outcome.

Measure time point of outcome：

Baseline, 24 weeks, and 32 weeks

Measure method：

A 22-item questionnaire measuring quality of life related to scoliosis, covering function, pain, self-image, mental health, and satisfaction. Scores range from 1 to 5 per domain, with a higher score indicating a better outcome.

指标中文名：

Italian Spine Youth Quality of Life (ISYQOL) Questionnaire Score

指标类型：

次要指标

Outcome：

Italian Spine Youth Quality of Life (ISYQOL) Questionnaire Score

Type：

Secondary indicator

测量时间点：

Baseline, 24 weeks, and 32 weeks

测量方法：

A 20-item questionnaire measuring disease-specific quality of life in adolescents with scoliosis. A higher total score indicates a better quality of life.

Measure time point of outcome：

Baseline, 24 weeks, and 32 weeks

Measure method：

A 20-item questionnaire measuring disease-specific quality of life in adolescents with scoliosis. A higher total score indicates a better quality of life.

指标中文名：

Spinal Appearance Questionnaire (SAQ) Score

指标类型：

次要指标

Outcome：

Spinal Appearance Questionnaire (SAQ) Score

Type：

Secondary indicator

测量时间点：

Baseline, 24 weeks, and 32 weeks

测量方法：

A questionnaire that assesses self-perception of spinal appearance. Scores range from 1 (best appearance) to 5 (worst appearance), with a lower total score indicating a more positive body image.

Measure time point of outcome：

Baseline, 24 weeks, and 32 weeks

Measure method：

A questionnaire that assesses self-perception of spinal appearance. Scores range from 1 (best appearance) to 5 (worst appearance), with a lower total score indicating a more positive body image.

指标中文名：

International Physical Activity Questionnaire-Short Form (IPAQ-C) Score

指标类型：

附加指标

Outcome：

International Physical Activity Questionnaire-Short Form (IPAQ-C) Score

Type：

Additional indicator

测量时间点：

Baseline, 24 weeks, and 32 weeks

测量方法：

A 9-item questionnaire that estimates weekly physical activity levels across different intensities (vigorous, moderate, walking, sitting). The score is reported as total Metabolic Equivalent of Task (MET)-minutes per week.

Measure time point of outcome：

Baseline, 24 weeks, and 32 weeks

Measure method：

A 9-item questionnaire that estimates weekly physical activity levels across different intensities (vigorous, moderate, walking, sitting). The score is reported as total Metabolic Equivalent of Task (MET)-minutes per week.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

NA

组织：

Sample Name：

NA

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 10 岁 years
最大 Max age 16 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）：

Randomization & Blinding Details Eligible participants were randomly allocated to either the PSSE intervention group or the standard care control group. The randomization sequence was computer-generated using block randomization with randomly mixed block sizes of 4 and 6. To ensure a balanced distribution of key prognostic factors, the randomization was stratified by: Curve type (right thoracic vs. thoracolumbar curve) Risser sign (0-1 vs. 2-3)

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

Randomization & Blinding Details Eligible participants were randomly allocated to either the PSSE intervention group or the standard care control group. The randomization sequence was computer-generated using block randomization with randomly mixed block sizes of 4 and 6. To ensure a balanced distribution of key prognostic factors, the randomization was stratified by: Curve type (right thoracic vs. thoracolumbar curve) Risser sign (0-1 vs. 2-3)

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：

Blinding (Masking): Who was blinded: Outcome assessors and the statistician analyzing the data were blinded to group assignment. Who was NOT blinded: Due to the nature of the exercise intervention, the participants and the therapists delivering the PSSE program could not be blinded. However, the treating therapists were not involved in the randomization process or the outcome assessments.

Blinding：

Blinding (Masking): Who was blinded: Outcome assessors and the statistician analyzing the data were blinded to group assignment. Who was NOT blinded: Due to the nature of the exercise intervention, the participants and the therapists delivering the PSSE program could not be blinded. However, the treating therapists were not involved in the randomization process or the outcome assessments.

是否共享原始数据：

IPD sharing

是Yes

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）：

Individual participant data that underlie the results reported will be shared after de-identification. Data will be available beginning 6 months following main results publication to researchers who provide a methodologically sound proposal. Data will be shared via secure data repository with a data use agreement.

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

Individual participant data that underlie the results reported will be shared after de-identification. Data will be available beginning 6 months following main results publication to researchers who provide a methodologically sound proposal. Data will be shared via secure data repository with a data use agreement.

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：

Data will be available beginning 6 months following main results publication to researchers who provide a methodologically sound proposal. Data will be shared via secure data repository with a data use agreement.

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

Data will be available beginning 6 months following main results publication to researchers who provide a methodologically sound proposal. Data will be shared via secure data repository with a data use agreement.

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：

  2025-11-12 16:15:35