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

Boyd, Roslyn N., Ziviani, Jenny, Sakzewski, Leanne, Miller, Laura, Bowden, Joanne, Cunnington, Ross, Ware, Robert, Guzzetta, Andrea, Macdonell, Richard A. L., Jackson, Graeme D., Abbott, David F. and Rose, Stephen (2013) 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. BMC Neurology, 13 68.1-68.17. doi:10.1186/1471-2377-13-68

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Author Boyd, Roslyn N.
Ziviani, Jenny
Sakzewski, Leanne
Miller, Laura
Bowden, Joanne
Cunnington, Ross
Ware, Robert
Guzzetta, Andrea
Macdonell, Richard A. L.
Jackson, Graeme D.
Abbott, David F.
Rose, Stephen
Title 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
Formatted title
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
Journal name BMC Neurology   Check publisher's open access policy
ISSN 1471-2377
Publication date 2013-06
Sub-type Article (original research)
DOI 10.1186/1471-2377-13-68
Open Access Status DOI
Volume 13
Start page 68.1
End page 68.17
Total pages 17
Place of publication London, United Kingdom
Publisher BioMed Central
Collection year 2014
Language eng
Formatted 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
Keyword Bimanual upper limb training
Brain (re)organisation
Cerebral palsy
Congenital hemiplegia
Disability and health
Functional magnetic resonance imaging (fMRI)
Hybrid constraint induced movement therapy (hCIMT)
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

 
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