Functional Intimate Apparel for Adolescents With Early Scoliosis
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      Adolescent idiopathic scoliosis (AIS) is a prevalent chronic condition that gradually leads
      to the three dimensional deformity of the spine. Spinal curvature increases in youths as
      puberty progresses. Generally, only observation is suggested for adolescents with early
      scoliosis (Cobb's angle ≤ 20°). Rigid brace treatment is too draconian for them due to the
      high corrective force which nearly constrains all movements. Flexible brace treatment is an
      alternative; however, its efficacy is still controversial. Functional intimate apparel with a
      specialized design for teenagers with scoliosis is limited and most part of them can only
      provide some improvement for bad postures, such as hunchback. A scientific approach should be
      used to design and develop functional intimate apparel as a treatment option for adolescents
      with early scoliosis.

      This project aims to combine clinical experience with textiles and materials sciences to
      research and develop a functional intimate apparel 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 a functional intimate apparel to wear for
      8 hours a day. Monitoring and observation will be provided during a 6-month wear trial. The
      effectiveness of the functional intimate apparel will be evaluated by pre- and post-
      treatment X-ray radiography and sonography.
    

Detailed description: 
      This project aims to combine clinical experience with textiles and materials sciences to
      research and develop a functional intimate apparel for adolescents with early scoliosis. As a
      result, this will reduce the future likelihood of brace wear or surgery.

      The design of functional intimate apparel will incorporate different mechanisms, such as a)
      compression and pulling forces through a close fit of the intimate apparel, b) lumbar flexion
      by using a supporting belt, c) transverse forces applied by inserting pads inside the pocket
      lining with the principle of the 3-point pressure system, d) axial rotation or coupled motion
      by using a system with uneven straps, and e) an active mechanism that aims to shift the trunk
      away from areas of pressure.

      In this study, the eligible subjects will be given a functional intimate apparel to wear for
      8 hours a day. Monitoring and observation will be provided during a 6-month wear trial. The
      effectiveness of the functional intimate apparel will be evaluated by pre- and post-
      treatment X-ray radiography and sonography.
    

Intervention name(s): Functional Intimate Apparel
Intervention type(s): Device
Intervention description(s): The design of functional intimate apparel will incorporate different mechanisms, such as a) compression and pulling forces through a close fit of the intimate apparel, b) lumbar flexion by using a supporting belt, c) transverse forces applied by inserting pads inside the pocket lining with the application of 3-point pressure system, d) axial rotation or coupled motion by using uneven straps, and e) an active mechanism that aims to shift the trunk away from areas of pressure.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are 2 groups of subjects. One group receives the treatment of functional intimate apparel which is called FIA group while one group receives observation only, which is called control group.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Functional intimate apparel; Adolescent Idiopathic scoliosis