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

NCT ID: NCT01776736

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-01
• Study Completion Date: 2021-12-31

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.

Conditions

Adolescent Idiopathic Scoliosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Posture Correction Girdle

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

Group Type: EXPERIMENTAL

Posture Correction Girdle

Intervention Type: DEVICE

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

Interventions

Posture Correction Girdle

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

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Joanne Yip

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joanne Yip, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Kit-Lun Yick, Ph.D

Role: STUDY_CHAIR

The Hong Kong Polytechnic University

Locations

The Hong Kong Polytechnic University

Hong Kong, , China

Countries

China

Other Identifiers

ITF-237-11

Identifier Type: -

Identifier Source: org_study_id