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Safety and Efficacy of Posture Correction Girdle for Adolescent With Early Scoliosis

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Posture Correction Girdle
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring Scoliosis, Posture correction

Eligibility Criteria

10 Years - 13 Years (Child)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 10 to 13 years
  • Diagnosis of AIS in early stage
  • Primary Cobb angle equals to or less than 20 degrees
  • Pre-menarchal or post-menarchal by no more than 1 year
  • Ability to read and understand English or Chinese
  • At high risk for curve progression
  • Skeletally immature (Risser grade 0, 1, or 2)
  • Physical and mental ability to adhere to posture correction girdle protocol

Exclusion Criteria:

  • Contraindications for x-ray exposure
  • Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
  • History of previous surgical or orthotic treatment for AIS
  • Contraindications for pulmonary and / or exercise tests
  • Psychiatric disorders
  • Recent trauma
  • Recent traumatic (emotional) event

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Posture Correction Girdle

Arm Description

Posture Correction Girdle applied for 8 hours per day. Clinical, radiographic, and self-report follow-up within the girdling period (6 months).

Outcomes

Primary Outcome Measures

Progression of the spinal curve
No progression of the spinal curve (no increase of Cobb angle) by radiographic measures.

Secondary Outcome Measures

Progression of the spinal curve
The progression of the spinal curve within control (increase of Cobb angle < 5 degrees)
Posture improvement
Improvement of posture by clinical photographs assessment

Full Information

First Posted
January 24, 2013
Last Updated
August 14, 2022
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT01776736
Brief Title
Safety and Efficacy of Posture Correction Girdle for Adolescent With Early Scoliosis
Official Title
Study of Posture Correction Girdle of Adolescents With Early Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2012 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
For AIS, the caring of patients with spinal deformities has a long and varied history. Severe spinal deformities can greatly reduce pulmonary and cardiac functions, which may lead to death from cardiopulmonary failure. Therefore, surgery is generally suggested when the curvature of the spine is greater than 45-50 degrees. The adverse psychological impact of orthoses treatment on patients and its poor compliance has been a well-recognised problem. Some orthotic research studies indicate that early intervention of spinal deformities is particularly desirable. Taking into consideration current clinical practices, if the curve is less than 20 degrees, even if the child is at a high risk of progressive spinal deformity during the age of 10-16 at puberty, treatment is nothing more than just observation. This project aims to combine clinical experience with textile and materials sciences to research and develop a posture correction girdle for adolescents with early scoliosis. As a result, this will reduce the future likelihood of brace wear or surgery. In this study, the eligible subjects will be given tailor-made posture correction girdles to wear it 8 hours daily. Monitoring and observation will be provided during the six months girdling period. Data will be collected before and after the girdling by X-ray radiograph for analysis, in order to comparison the spine curvature condition. Locomotion of the subject with and without wearing the posture correction girdle will also be reference.
Detailed Description
For AIS, the caring of patients with spinal deformities has a long and varied history. Severe spinal deformities can greatly reduce pulmonary and cardiac functions, which may lead to death from cardiopulmonary failure. Therefore, surgery is generally suggested when the curvature of the spine is greater than 45-50 degrees. The adverse psychological impact of orthoses treatment on patients and its poor compliance has been a well-recognised problem. Some orthotic research studies indicate that early intervention of spinal deformities is particularly desirable. Taking into consideration current clinical practices, if the curve is less than 20 degrees, even if the child is at a high risk of progressive spinal deformity during the age of 10-16 at puberty, treatment is nothing more than just observation. This project aims to combine clinical experience with textile and materials sciences to research and develop a posture correction girdle for adolescents with early scoliosis. As a result, this will reduce the future likelihood of brace wear or surgery. The eligible subjects will be given tailor-made posture correction girdles. Monitoring and observation will be provided during the girdling period. Data will be collected before and after the girdling by X-ray radiograph for analysis, in order to comparison the spine curvature condition. Locomotion of the subject with and without wearing the posture correction girdle will also be reference.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
Scoliosis, Posture correction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Posture Correction Girdle
Arm Type
Experimental
Arm Description
Posture Correction Girdle applied for 8 hours per day. Clinical, radiographic, and self-report follow-up within the girdling period (6 months).
Intervention Type
Device
Intervention Name(s)
Posture Correction Girdle
Intervention Description
Posture Correction Girdle applied for 8 hours per day. Clinical, radiographic, and self-report follow-up within the girdling period (6 months).
Primary Outcome Measure Information:
Title
Progression of the spinal curve
Description
No progression of the spinal curve (no increase of Cobb angle) by radiographic measures.
Time Frame
From baseline to 6 months
Secondary Outcome Measure Information:
Title
Progression of the spinal curve
Description
The progression of the spinal curve within control (increase of Cobb angle < 5 degrees)
Time Frame
From baseline to 6 months
Title
Posture improvement
Description
Improvement of posture by clinical photographs assessment
Time Frame
From baseline to 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 10 to 13 years Diagnosis of AIS in early stage Primary Cobb angle equals to or less than 20 degrees Pre-menarchal or post-menarchal by no more than 1 year Ability to read and understand English or Chinese At high risk for curve progression Skeletally immature (Risser grade 0, 1, or 2) Physical and mental ability to adhere to posture correction girdle protocol Exclusion Criteria: Contraindications for x-ray exposure Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature History of previous surgical or orthotic treatment for AIS Contraindications for pulmonary and / or exercise tests Psychiatric disorders Recent trauma Recent traumatic (emotional) event
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Yip, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kit-Lun Yick, Ph.D
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Study Chair
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
China

12. IPD Sharing Statement

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Safety and Efficacy of Posture Correction Girdle for Adolescent With Early Scoliosis

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