Objectives Congenital hemiplegia is the most common form of cerebral palsy (CP). Children with unilateral CP show signs of upper limb asymmetry by 8 months corrected age (ca) but are frequently not referred to therapy until after 12 months ca. This study compares the efficacy of infant-friendly modified constraint-induced movement therapy (Baby mCIMT) to infant friendly bimanual therapy (Baby BIM) on upper limb, cognitive and neuroplasticity outcomes in a multisite randomised comparison trial.
Methods and analysis 150 infants (75 in each group), aged between 3 and 6 months ca, with asymmetric brain injury and clinical signs of upper extremity asymmetry will be recruited. Children will be randomised centrally to receive equal doses of either Baby mCIMT or Baby BIM. Baby mCIMT comprises restraint of the unimpaired hand using a simple restraint (eg, glove, sock), combined with intensive parent implemented practice focusing on active use of the impaired hand in a play-based context. In contrast, Baby BIM promotes active play requiring both hands in a play-based context. Both interventions will be delivered by parents at home with monthly home visits and interim telecommunication support by study therapists. Assessments will be conducted at study entry; at 6, 12 months ca immediately postintervention (primary outcome) and 24 months ca (retention). The primary outcome will be the Mini-Assisting Hand Assessment. Secondary outcomes include the Bayley Scale for Infant and Toddler Development (cognitive and motor domains) and the Hand Assessment of Infants. A subset of children will undertake MRI scans at 24 months ca to evaluate brain lesion severity and brain (re)organisation after intervention.
Ethics and dissemination Full ethical approvals for this study have been obtained from the relevant sites. The findings will be disseminated in peer-reviewed publications.
Trial registration number Australian and New Zealand Clinical Trials Registry: ACTRN12615000180516, Pre results.
- brain injury
- congenital hemiplegia
- early intervention
- cerebral palsy
- constraint induced movement therapy
- bimanual therapy
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Contributors RNB is the chief investigator (CI) and together with JZ, LS, IN, NB, KP, CE, SG, AG, KW, JV, CM, RW and SR designed, established and achieved funding for this research study. CM, MW, LF also contributed to study design. RNB, LS, CM, MW, SG and CE are responsible for ethics applications and reporting. RNB, LS, IN, CE and SG are responsible for recruitment. RNB, LS, IN, CE, SG and CM supervise the data collection and implementation of the training programme. RNB, KP and SR were responsible for design and implementation of the Advanced Brain Imaging outcomes. RNB, JZ, LS, IN, NB, KP, CE, SG, AG, KW, JV, CM, RW will take lead roles on preparation for publications on the clinical outcomes of the study and RNB, SR, SF, KP and AG will take lead roles on the neuroscience publications from the study. RW will take on a lead role of the statistical analysis for the study. RB and the CIs drafted the final version of this manuscript. All authors contributed to the writing of this manuscript and have critically reviewed and approved the final version. All data from this study will be submitted to peer review journals.
Funding This protocol and randomised trial is funded by the Australian National Health and Medical Research Council (NHMRC) Project Grant for REACH 1059332; NHMRC Early Career Fellowship no.1090828 (LS); NHMRC Research Fellowship (RB) 1105038. This study is funded by the Australian National Health and Medical Research Council (NHMRC) for a project grant no 1078877. The NHMRC has provided people support for the following team members: a Research Fellowship (RB, 1105038), Early Career Fellowship (LS, No1090828, KW, No 631712).
Competing interests None declared.
Patient consent Obtained.
Ethics approval Full ethical approvals for this study have been obtained from the Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/14/QRCH/376: ethical review provided for 20 sites: Lady Cilento Children’s Hospital, Royal Brisbane and Women’s Hospital, Mater Mothers’ Hospital, Gold Coast University Hospital, Sunshine Coast University Hospital, Nambour General Hospital, The Children’s Hospital at Westmead, Children’s Hospital Randwick, Westmead Hospital, Royal North Shore Hospital, Liverpool Hospital, Nepean Hospital, Royal Prince Alfred Hospital, Royal Women’s Hospital, St George Hospital, Blacktown Hospital, Campbelltown Hospital, John Hunter Children’s Hospital, Royal Children’s Hospital and Monash Medical Centre), Medical Ethics Committee of The University of Queensland (2015000013), Cerebral Palsy Alliance Ethics Committee (2015-01-02) and the Princess Margaret Hospital Human Research Ethics Committee (2015023EP: ethical review provided for two sites: Princess Margaret Hospital for Children and King Edward Memorial Hospital for Women).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The funding bodies have no role in the study design, data collection, management, analysis and interpretation of data; writing of the report; and the decision to submit the reports for publication. The authors have ultimate authority over these activities. There is no additional unpublished data from this study to be shared.
Press Release None.
Correction notice None.
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