COMBIT: Protocol of a randomised comparison trial of COMbined modified constraint induced movement therapy and bimanual intensive training with distributed model of standard upper limb rehabilitation in children with congenital hemiplegia

摘要

Introduction: Children with congenital hemiplegia often present with limitations in using their impaired upper limbwhich impacts on independence in activities of daily living, societal participation and quality of life. Traditional therapyhas adopted a bimanual training approach (BIM) and more recently, modified constraint induced movement therapy(mCIMT) has emerged as a promising unimanual approach. Evidence of enhanced neuroplasticity following mCIMTsuggests that the sequential application of mCIMT followed by bimanual training may optimise outcomes (HybridCIMT). It remains unclear whether more intensely delivered group based interventions (hCIMT) are superior todistributed models of individualised therapy. This study aims to determine the optimal density of upper limb trainingfor children with congenital hemiplegia.Methods and analyses: A total of 50 children (25 in each group) with congenital hemiplegia will be recruited toparticipate in this randomized comparison trial. Children will be matched in pairs at baseline and randomly allocated toreceive an intensive block group hybrid model of combined mCIMT followed by intensive bimanual training deliveredin a day camp model (COMBiT; total dose 45 hours direct, 10 hours of indirect therapy), or a distributed model ofstandard occupational therapy and physiotherapy care (SC) over 12 weeks (total 45 hours direct and indirect therapy).Outcomes will be assessed at 13 weeks after commencement, and retention of effects tested at 26 weeks. The primaryoutcomes will be bimanual coordination and unimanual upper-limb capacity. Secondary outcomes will beparticipation and quality of life. Advanced brain imaging will assess neurovascular changes in response to treatment.Analysis will follow standard principles for RCTs, using two-group comparisons on all participants on an intentionto-treatbasis. Comparisons will be between treatment groups using generalized linear models.