Safety and Efficacy of Posture Correction Girdle for Adolescent With Early Scoliosis
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

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.
    

Intervention name(s): Posture Correction Girdle
Intervention type(s): Device
Intervention description(s): Posture Correction Girdle applied for 8 hours per day. Clinical, radiographic, and self-report follow-up within the girdling period (6 months).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Scoliosis; Posture correction