ChiCTR-IOR-17013514 版本V1.0 版本创建时间2017/11/23 23:02:50 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：

 ChiCTR-IOR-17013514 

最近更新日期：

Date of Last Refreshed on：

 2017-11-23 23:02:35 

注册时间：

Date of Registration：

 2017-11-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

三維超聲波檢查系統運用於脊柱側彎評估和改善脊柱矯形器的設計

Public title：

Design and Evaluation of Orthotic Treatment for Patients with Adolescent Idiopathic Scoliosis using a Purpose-design Assessment Frame and 3-Dimensional Clinical Ultrasound Analysis

注册题目简写：

English Acronym：

Using ultrasound and assessment frame to design and evaluate the spinal orthoses for scoliotic patients

研究课题的正式科学名称：

三維超聲波檢查系統運用於脊柱側彎評估和改善脊柱矯形器的設計

Scientific title：

Design and Evaluation of Orthotic Treatment for Patients with Adolescent Idiopathic Scoliosis using a Purpose-design Assessment Frame and 3-Dimensional Clinical Ultrasound Analysis

研究课题代号(代码)：

Study subject ID：

 CREC Ref: 2016.134

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：

CUHK_CCRB00570

申请注册联系人：

Sai-wing SIN 

研究负责人：

Sai-wing SIN 

Applicant：

Sai-wing SIN 

Study leader：

Sai-wing SIN 

申请注册联系人电话：

Applicant telephone：

 +852 235053930

研究负责人电话：

Study leader's
telephone：

+852 235053930

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：

 sinsw@ha.org.hk

研究负责人电子邮件：

Study leader's E-mail：

 sinsw@ha.org.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/491

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/491

申请注册联系人通讯地址：

Department of Prosthetics and Orthotics, Prince of Wales Hospital, CUHK, Shatin, Hong Kong SAR, China

研究负责人通讯地址：

Department of Prosthetics and Orthotics, Prince of Wales Hospital, CUHK, Shatin, Hong Kong SAR, China

Applicant address：

Department of Prosthetics and Orthotics, Prince of Wales Hospital, CUHK, Shatin, Hong Kong SAR, China

Study leader's address：

Department of Prosthetics and Orthotics, Prince of Wales Hospital, CUHK, Shatin, Hong Kong SAR, 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：

申请人所在单位：

Department of Prosthetics and Orthotics, PWH

Applicant's institution：

Department of Prosthetics and Orthotics, PWH

研究负责人所在单位：

Department of Prosthetics and Orthotics, PWH

Affiliation of the Leader：

Department of Prosthetics and Orthotics, PWH

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：

 2016.134

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2013-08-26 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

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：

Sai-wing SIN

Primary sponsor：

Sai-wing SIN

研究实施负责（组长）单位地址：

Department of Prosthetics and Orthotics, Prince of Wales Hospital, CUHK, Shatin, Hong Kong SAR, China

Primary sponsor's address：

Department of Prosthetics and Orthotics, Prince of Wales Hospital, CUHK, Shatin, Hong Kong SAR, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

No

Source(s) of funding：

No

研究疾病：

脊柱側彎  

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：

三維超聲波檢查系統運用於脊柱側彎評估和改善脊柱矯形器的設計  

Objectives of Study：

Design and Evaluation of Orthotic Treatment for Patients with Adolescent Idiopathic Scoliosis using a Purpose-design Assessment Frame and 3-Dimensional Clinical Ultrasound Analysis

药物成份或治疗方案详述：

Experimental group: To control the progression of moderate curves in patients with adolescent idiopathic scoliosis (AIS), spinal orthoses have been prescribed for decades.The procedure of orthosis design initiates with the casting (scanning) of the patient's trunk as a reference for the fabrication of orthosis. Traditionally, the experiential judgment of orthotist and available pre-orthosis radiographs play the fundamental role in the procedure to modify the captured trunk model. This subjective method necessitates the development of an objective real-time method of orthosis casting while the correction of spinal curvature during the casting (scanning) is documented to achieve the intended correction before the fabrication of orthosis. This prospective randomized study evaluates the effectiveness of an innovative design method with 3-D ultrasound and assessment frame in orthotic treatment of scoliotic patients to assess the potential superiority of this modified casting procedure over the conventional casting method. The brace wearing will continue according to the protocols of SRS/SOSORT normally till complete skeletal maturity. 1 hour in assessment/casting session and 15 minutes during the first in-brace assessment session. Once during the casting and then once during the first in-brace assessment. Control group: The control group will receive the conventional casting procedure for the orthosis design of adolescent idiopathic scoliosis. Both groups will wear the brace according to the protocols introduced by SRS/SOSORT. No difference from usual conventional treatment in terms of brace dosage. 

Description for medicine or protocol of treatment in detail：

Experimental group: To control the progression of moderate curves in patients with adolescent idiopathic scoliosis (AIS), spinal orthoses have been prescribed for decades.The procedure of orthosis design initiates with the casting (scanning) of the patient's trunk as a reference for the fabrication of orthosis. Traditionally, the experiential judgment of orthotist and available pre-orthosis radiographs play the fundamental role in the procedure to modify the captured trunk model. This subjective method necessitates the development of an objective real-time method of orthosis casting while the correction of spinal curvature during the casting (scanning) is documented to achieve the intended correction before the fabrication of orthosis. This prospective randomized study evaluates the effectiveness of an innovative design method with 3-D ultrasound and assessment frame in orthotic treatment of scoliotic patients to assess the potential superiority of this modified casting procedure over the conventional casting method. The brace wearing will continue according to the protocols of SRS/SOSORT normally till complete skeletal maturity. 1 hour in assessment/casting session and 15 minutes during the first in-brace assessment session. Once during the casting and then once during the first in-brace assessment. Control group: The control group will receive the conventional casting procedure for the orthosis design of adolescent idiopathic scoliosis. Both groups will wear the brace according to the protocols introduced by SRS/SOSORT. No difference from usual conventional treatment in terms of brace dosage. 

纳入标准：

1. Adolescent idiopathic patients;
2. Risser's Sign 0-2;
3. Primary curve magnitude 25 to 40 degrees;
4. Females either pre-menarche or less than one year post-menacarche.

Inclusion criteria

1. Adolescent idiopathic patients;
2. Risser's Sign 0-2;
3. Primary curve magnitude 25 to 40 degrees;
4. Females either pre-menarche or less than one year post-menacarche.

排除标准：

1. Physical or mental disability preventing patients from complying with the bracing protocol;
2. Curve types of high thoracic due to the limitation of the apparatus to apply the force in that level.

Exclusion criteria：

1. Physical or mental disability preventing patients from complying with the bracing protocol;
2. Curve types of high thoracic due to the limitation of the apparatus to apply the force in that level.

研究实施时间：

Study execute time：

从 From 1990-01-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2017-11-27 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 40

Group：

Two groups

Sample size：

干预措施：

No intervention

干预措施代码：

Intervention：

No intervention

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Prince of Wales Hospital, CUHK 

单位级别：

 Prince of Wales Hospital, CUHK 

Institution
hospital：

Prince of Wales Hospital, CUHK

Level of the institution：

Prince of Wales Hospital, CUHK

测量指标：

Outcomes：

指标中文名：

In-brace correction

指标类型：

主要指标

Outcome：

In-brace correction

Type：

Primary indicator

测量时间点：

Before treatment-assessment session (0 week), fitting session , first in-brace X-ray session (4-6 weeks)

测量方法：

≥30% Correction in 3D ultrasound assessment

Measure time point of outcome：

Before treatment-assessment session (0 week), fitting session , first in-brace X-ray session (4-6 weeks)

Measure method：

≥30% Correction in 3D ultrasound assessment

指标中文名：

Changes in Cobb angle

指标类型：

次要指标

Outcome：

Changes in Cobb angle

Type：

Secondary indicator

测量时间点：

Before treatment-assessment session (0 week), first in-brace X-ray session (4-6 weeks)

测量方法：

≤ 5° with and without brace assessed in radiographs

Measure time point of outcome：

Before treatment-assessment session (0 week), first in-brace X-ray session (4-6 weeks)

Measure method：

≤ 5° with and without brace assessed in radiographs

采集人体标本：

Collecting sample(s)
from participants：

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 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）：

Randomized control trial

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

Randomized control trial

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Single-blind, Investigator/research team

Blinding：

Single-blind, Investigator/research team

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

Not stated

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

Not stated

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：

Not stated

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

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2017-11-23 23:02:35