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. Boyd, Jenny Ziviani, Leanne Sakzewski, Laura Miller, Joanne Bowden, Ross Cunnington, Robert Ware, Andrea Guzzetta, Richard AL Macdonell, Graeme D. Jackson, David F. Abbott, Stephen Rose

Research output: Contribution to journalArticle

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.

Original languageEnglish
Article number68
Pages (from-to)1-17
Number of pages17
JournalBMC Neurology
Volume13
DOIs
Publication statusPublished - Jun 28 2013

Fingerprint

Hemiplegia
Upper Extremity
Rehabilitation
Therapeutics
Quality of Life
Neuronal Plasticity
Occupational Therapy
Activities of Daily Living
Neuroimaging
Linear Models

Keywords

  • 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)
  • International classification of functioning
  • Mastery motivation
  • Modified constraint induced movement therapy (mCIMT)
  • Randomised clinical trial
  • Stroke

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

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; AL Macdonell, Richard; Jackson, Graeme D.; Abbott, David F.; Rose, Stephen.

In: BMC Neurology, Vol. 13, 68, 28.06.2013, p. 1-17.

Research output: Contribution to journalArticle

Boyd, Roslyn N. ; Ziviani, Jenny ; Sakzewski, Leanne ; Miller, Laura ; Bowden, Joanne ; Cunnington, Ross ; Ware, Robert ; Guzzetta, Andrea ; AL Macdonell, Richard ; Jackson, Graeme D. ; Abbott, David F. ; Rose, Stephen. / 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. In: BMC Neurology. 2013 ; Vol. 13. pp. 1-17.
@article{be1aa64bfc1a417884aa06b1c5a7a17c,
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",
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 = "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), International classification of functioning, Mastery motivation, Modified constraint induced movement therapy (mCIMT), Randomised clinical trial, Stroke",
author = "Boyd, {Roslyn N.} and Jenny Ziviani and Leanne Sakzewski and Laura Miller and Joanne Bowden and Ross Cunnington and Robert Ware and Andrea Guzzetta and {AL Macdonell}, Richard and Jackson, {Graeme D.} and Abbott, {David F.} and Stephen Rose",
year = "2013",
month = "6",
day = "28",
doi = "10.1186/1471-2377-13-68",
language = "English",
volume = "13",
pages = "1--17",
journal = "BMC Neurology",
issn = "1471-2377",
publisher = "BioMed Central",

}

TY - JOUR

T1 - COMBIT

T2 - 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

AU - Boyd, Roslyn N.

AU - Ziviani, Jenny

AU - Sakzewski, Leanne

AU - Miller, Laura

AU - Bowden, Joanne

AU - Cunnington, Ross

AU - Ware, Robert

AU - Guzzetta, Andrea

AU - AL Macdonell, Richard

AU - Jackson, Graeme D.

AU - Abbott, David F.

AU - Rose, Stephen

PY - 2013/6/28

Y1 - 2013/6/28

N2 - 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.

AB - 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.

KW - Bimanual upper limb training

KW - Brain (re)organisation

KW - Cerebral palsy

KW - Congenital hemiplegia

KW - Disability and health

KW - Functional magnetic resonance imaging (fMRI)

KW - Hybrid constraint induced movement therapy (hCIMT)

KW - International classification of functioning

KW - Mastery motivation

KW - Modified constraint induced movement therapy (mCIMT)

KW - Randomised clinical trial

KW - Stroke

UR - http://www.scopus.com/inward/record.url?scp=84883250017&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84883250017&partnerID=8YFLogxK

U2 - 10.1186/1471-2377-13-68

DO - 10.1186/1471-2377-13-68

M3 - Article

C2 - 23809257

AN - SCOPUS:84883250017

VL - 13

SP - 1

EP - 17

JO - BMC Neurology

JF - BMC Neurology

SN - 1471-2377

M1 - 68

ER -