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Open Access Study protocol

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

Roslyn N Boyd12*, Jenny Ziviani23, Leanne Sakzewski12, Laura Miller12, Joanne Bowden1, Ross Cunnington4, Robert Ware78, Andrea Guzzetta19, Richard AL Macdonell10116, Graeme D Jackson10126, David F Abbott106 and Stephen Rose5

Author Affiliations

1 Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, Faculty of Health Sciences, The University of Queensland, Brisbane, Australia

2 Children’s Allied Health Research, Royal Children’s Hospital Herston, Brisbane, Australia

3 School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia

4 School of Psychology & Queensland Brain Institute, The University of Queensland, Brisbane, Australia

5 CSIRO, ICT Australian e-Health Research Centre, Royal Brisbane and Women's Hospital, Centre for Clinical Research, The University of Queensland, Brisbane, Queensland, Australia

6 Brain Research Institute, Florey Institute of Neuroscience and Mental Health (Melbourne Brain Centre, Austin Hospital), Victoria, Australia

7 Queensland Children’s Medical Research Institute, The University of Queensland, Brisbane, Queensland, Australia

8 School of Population Health, The University of Queensland, Brisbane, Australia

9 Department of Developmental Neuroscience, Stella Maris Scientific Institute, Pisa, Italy

10 Department of Medicine, The University of Melbourne, Victoria, Australia

11 Department of Neurology, Austin Health, Heidelberg, Victoria, Australia

12 Department of Radiology, The University of Melbourne, Victoria, Australia

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BMC Neurology 2013, 13:68  doi:10.1186/1471-2377-13-68

Published: 28 June 2013

Abstract

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.

Trial registration

ACTRN12613000181707

Keywords:
Congenital hemiplegia, Cerebral palsy, Stroke, Randomised clinical trial, Modified constraint induced movement therapy (mCIMT), Bimanual upper limb training, Hybrid constraint induced movement therapy (hCIMT); Functional magnetic resonance imaging (fMRI), Brain (re)organisation, International classification of functioning, Disability and health, Mastery motivation