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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 RN, Ziviani J, Sakzewski L, Miller L, Bowden J, Cunnington R, Ware R, Guzzetta A, Al Macdonell R, Jackson GD, Abbott DF, Rose S - BMC Neurol (2013)

Bottom Line: It remains unclear whether more intensely delivered group based interventions (hCIMT) are superior to distributed models of individualised therapy.Secondary outcomes will be participation and quality of life.ACTRN12613000181707.

View Article: PubMed Central - HTML - PubMed

Affiliation: Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, Faculty of Health Sciences, The University of Queensland, Brisbane, Australia. r.boyd@uq.edu.au

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.

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Related in: MedlinePlus

CONSORT flow chart for COMBiT trial.
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Figure 1: CONSORT flow chart for COMBiT trial.

Mentions: Children will attend either the Royal Children’s Hospital or The University of Queensland in Brisbane for baseline and follow up assessments. Children randomised to COMBiT will participate in a two week day camp during school holidays commencing within one month of baseline assessments. Participants randomised to standard care will be allocated a local therapist and individual therapy sessions will commence within one month of baseline assessments. The experimental design and outcome measures are depicted in Figure 1.


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 RN, Ziviani J, Sakzewski L, Miller L, Bowden J, Cunnington R, Ware R, Guzzetta A, Al Macdonell R, Jackson GD, Abbott DF, Rose S - BMC Neurol (2013)

CONSORT flow chart for COMBiT trial.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3750247&req=5

Figure 1: CONSORT flow chart for COMBiT trial.
Mentions: Children will attend either the Royal Children’s Hospital or The University of Queensland in Brisbane for baseline and follow up assessments. Children randomised to COMBiT will participate in a two week day camp during school holidays commencing within one month of baseline assessments. Participants randomised to standard care will be allocated a local therapist and individual therapy sessions will commence within one month of baseline assessments. The experimental design and outcome measures are depicted in Figure 1.

Bottom Line: It remains unclear whether more intensely delivered group based interventions (hCIMT) are superior to distributed models of individualised therapy.Secondary outcomes will be participation and quality of life.ACTRN12613000181707.

View Article: PubMed Central - HTML - PubMed

Affiliation: Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, Faculty of Health Sciences, The University of Queensland, Brisbane, Australia. r.boyd@uq.edu.au

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.

Show MeSH
Related in: MedlinePlus