NCT01776736

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

Study of Posture Correction Girdle of Adolescents With Early Scoliosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: Female
• Age: 10 Years – 13 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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).

Timeline

• Start date: 2012-07-01
• Primary completion: 2020-12-30
• Completion: 2021-12-31
• First posted: 2013-01-28
• Last updated: 2022-08-16

Locations

1 site across 1 country: China