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
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Introduction: Children with congenital hemiplegia often present with limitations in using their impaired upper limb which impacts on independence in activities of daily living, societal participation and quality of life. Traditional therapy has 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 mCIMT suggests that the sequential application of mCIMT followed by bimanual training may optimise outcomes (Hybrid CIMT). It remains unclear whether more intensely delivered group based interventions (hCIMT) are superior to distributed models of individualised therapy. This study aims to determine the optimal density of upper limb training for children with congenital hemiplegia.Methods and analyses: A total of 50 children (25 in each group) with congenital hemiplegia will be recruited to participate in this randomized comparison trial. Children will be matched in pairs at baseline and randomly allocated to receive an intensive block group hybrid model of combined mCIMT followed by intensive bimanual training delivered in a day camp model (COMBiT; total dose 45 hours direct, 10 hours of indirect therapy), or a distributed model of standard 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 primary outcomes will be bimanual coordination and unimanual upper-limb capacity. Secondary outcomes will be participation 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 intention-to-treat basis. Comparisons will be between treatment groups using generalized linear models.
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INCITE: A randomised trial comparing constraint induced movement therapy and bimanual training in children with congenital hemiplegiaBoyd, Roslyn; Sakzewski, L.; Ziviani, J.; Abbott, D.; Badawy, R.; Gilmore, R.; Provan, K.; Tournier, J.; Macdonell, R.; Jackson, G. (2010)Background: Congenital hemiplegia is the most common form of cerebral palsy (CP) accounting for 1 in 1300 live births. These children have limitations in capacity to use the impaired upper limb and bimanual coordination ...
Participation outcomes in a randomized trial of 2 models of upper-limb rehabilitation for children with congenital hemiplegiaSakzewski, L.; Ziviani, J.; Abbott, D.; MacDonell, R.; Jackson, G.; Boyd, Roslyn (2011)Objective: To determine if constraint-induced movement therapy (CIMT) is more effective than bimanual training to improve occupational performance and participation in children with congenital hemiplegia. Design: Single-blind ...
Sakzewski, L.; Ziviani, J.; Boyd, Roslyn (2011)Objective: To delineate characteristics of best responders in a randomized trial comparing constraint-induced movement therapy (CIMT) to bimanual training for children with unilateral cerebral palsy. Design: Secondary ...