Brace Weaning Protocol Comparing Gradual and Immediate Weaning
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      This is a non-blinded, randomized controlled trial for testing two brace weaning protocols
      namely immediate removal of brace or gradual weaning of brace over a course of 6 months for
      adolescent idiopathic scoliosis (AIS) patients. These patients will have follow-up visits at
      6-months, 12-months and 24-months intervals. By comparing between the two groups in terms of
      change of Cobb angle, truncal balance, health-related quality of life measures at the set
      time-points, the investigators aim to gain insights of whether different brace-weaning
      protocol will be more beneficial in patients' clinical and quality of life measure outcomes.
    

Detailed description: 
      The aims of this study are: 1) To compare the degree of Cobb angle and truncal balance
      maintenance between immediate removal and gradual brace weaning protocols for AIS patients
      who have completed brace treatment; 2) To determine factors for poor maintenance of Cobb
      angle and truncal balance after brace weaning; 3) To determine if the current standardized
      criteria for initiating brace weaning is appropriate.

      The investigators' hypothesis is that an AIS patient requires gradual brace weaning to allow
      better adaptation to an unloaded environment without the brace thereby resulting with a
      better truncal balance. It is also hypothesized that the immediate removal of brace for a AIS
      patient is as effective in terminating bracing treatment when compared to gradual brace
      weaning over a 6-month period.

      The investigators will recruit AIS patients managed at the Duchess of Kent Children's
      Hospital (DKCH) in Hong Kong. As there is no definition for "brace weaning", we adopt the
      protocol that our center has been using. Hence the investigators will be comparing two
      protocols: 1) brace wearing time shortened to night wearing for 6 more months before stopping
      bracing altogether or 2) immediate brace weaning on the day of patient recruitment. All
      patients will be recruited on the day of clinic consultation where the decision for brace
      weaning is made. Those with underarm (Boston) bracing are included in the study. All subjects
      are followed-up longitudinally up to 2 years after brace weaning has been issued. Hence this
      includes three clinic visits with one at 6 months to complete the gradual brace weaning
      protocol, and at 1 and 2 years to observe for any delayed changes to the overall curvature
      and balance including loss of truncal balance and Cobb angle deterioration. This does not
      deviate significantly from our usual care as all AIS subjects are usually followed-up at
      6-monthly intervals and thus this duration of follow-up is strictly adherent to and
      standardized.

      Eligible patients who have consented to take part will be randomly allocated to one of the
      two protocols, and group designation will be decided by a computer-generated randomized
      table. Restricted randomization through blocking will be used according to the equal
      proportion rule (1:1). The random allocation sequence will be managed independently, and the
      random coding is concealed to all research staff until all data analyses have been completed.
      The clinicians and research assistants will not be blinded to treatment allocation, as the
      participants are required to implement bracing protocols and schedule longitudinal follow-up.

      Apart from the Cobb angle measurement, all subjects undergo weight, height and arm span
      measurements, health-related quality of life (HRQOL) and utility measurements, and whole
      spine standing posteroanterior (PA) and lateral radiographs at each clinic visit as per
      routine clinic protocol. The refined Scoliosis Research Society 22-item (SRS-22r)
      questionnaire and the EuroQoL 5-Dimension 5-Level (EQ5D) questionnaire will thus be provided
      at every visit.
    

Intervention name(s): Brace weaning
Intervention type(s): Other
Intervention description(s): For AIS patients who have been wearing Boston brace and attend clinic consultation where the decision for brace weaning is made, then weaning protocol of either arm will be prescribed
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A non-blinded, randomized controlled trial for testing two brace weaning protocols, being immediate removal of brace or gradual weaning of brace, over a course of 6 months.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: brace weaning