Ergonomic Brace Wear for Adolescent Idiopathic Scoliosis
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      This study assesses the effectiveness of a new scoliosis brace design for adolescent
      idiopathic scoliosis (AIS) patients, named Ergonomic Brace, by comparing the outcome with
      hard brace in terms of three aspects:

        1. To assess the efficacy in spinal correction

        2. To evaluate the improvement made to the body appearance of AIS subjects

        3. To evaluate the impacts on the quality of life (QoL) of AIS subjects

      All participants will be fitted with an Ergonomic Brace and required to wear it during the
      days of experiment only. The ongoing treatment with hard brace will not be substituted with
      the Ergonomic Brace, unless its immediate treatment effect is equivalent to hard brace and
      with approval from the doctor.
    

Detailed description: 
      1. To assess the efficacy in spinal correction

           The efficacy of the Ergonomic Brace refers to the magnitude of spinal correction that
           could be obtained for patients with AIS. The assessments in this study focus on two
           aspects, which are i) the in-brace correction and ii) the interface pressure. In-brace
           correction is used to judge the quality of bracing and also a prognostic indicator for
           the long-term treatment outcome. Clinical parameters such as Cobb angle, vertebral
           rotation and trunk listing will be measured with radiographs by a single observer.
           Interface pressure in this study refers to the pressure between the brace and the trunk
           of subject. The purpose is to assess the time response of trunk to the intervention of
           the Ergonomic Brace, and correlation will also be made with the extent of spinal
           correction.

        2. To evaluate the improvement made to the body appearance of AIS subjects

           The trunk aesthetic profile of AIS subjects are being affected by spinal deformities.
           Surface topography of the subjects will be captured by 3D body scanner, and followed by
           the evaluation of body aesthetics through the trunk asymmetry scales called POTSI and
           ATSI index. The purpose is to compare the surface topography change before and after
           wearing the Ergonomic Brace.

        3. To evaluate the impacts on the QoL of AIS subjects

      Bracing can negatively affect the QoL of patients with AIS. The Chinese version of Brace
      Questionnaire (BrQ) will be adopted in this study to compare the impact of hard brace and
      Ergonomic Brace on the QoL of AIS subjects. Difficulties experienced by AIS subjects during
      bracing will be highlighted and used for future improvements in scoliosis brace design.
    

Intervention name(s): Ergonomic Brace vs hard brace
Intervention type(s): Device
Intervention description(s): Visit 1:
Usual check-up: standing in-brace radiograph of hard brace and doctor consultation
Pressure measurement of participant wearing their hard brace
Visit 2:
Brace Questionnaire (BrQ) for hard brace; Trunk Appearance Perception Scale (TAPS)
3D body scanning (before wearing the Ergonomic Brace)
Fitting of the Ergonomic Brace
Pressure measurement of participant wearing the Ergonomic Brace (instant)
Pressure measurement of participant wearing the Ergonomic Brace (after 2 hours)
3D body scanning (after wearing the Ergonomic Brace for 2 hours)
Brace Questionnaire (BrQ) for the Ergonomic Brace
Visit 3:
Standing in-brace radiograph of the Ergonomic Brace
Doctor consultation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Scoliosis brace; Conventional treatment for Adolescent Idiopathic Scoliosis; In-brace correction; Trunk listing; Vertebral rotation; Interface pressure; 3D body scanning; Surface topography; Trunk asymmetry; Quality of Life