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

IntroductionChildren 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 analysesA 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 registrationACTRN12613000181707

Automated injury segmentation to assist in the treatment of children with cerebral palsy

“…Study participants included children who were recruited as part of ongoing studies of children with unilateral CP [Boyd et al, 2013a;Boyd et al, 2013b]. For both studies, ethical approval was granted from the appropriate ethics committees.…”

“…For most of the children involved in this study (n = 89), several clinical scores of patient function were measured 0-22 weeks after MRI scanning as part of the ongoing studies on children with CP [Boyd et al, 2013a;Boyd et al, 2013b], in order to provide an overview of patient function. In this thesis, six of those clinical scores were utilised to represent patient motor, cognitive, visual and communicative function.…”

Measuring motor-training induced neuroplasticity using diffusion and functional MRI: a sensitive, pathology-robust approach

“…279 This difference reflects recovery of these participants' entire 7-16 years of life, which can be considered as an upper limit one can expect from several months of therapy. 11). Based on this literature, an increase of 8% was considered to be a balanced estimate of change for effective therapies conducted over a 6-month time frame (See Table 11).…”

“…Hybrid CIMT, in which the child trains with mCIMT prior to BIM, is another approach. 11 mCIMT and BIM are increasingly being delivered to individuals and groups in real-life situations to provide context to motor skill learning. 12 However, such therapy requires expertise, can be costly, and is not always accessible.…”

“…24 Family ecology and the therapeutic context were also identified as critical factors that influenced children's mastery motivation and engagement in therapy. 24 Although long-term retention of the functionality gained from upper-limb therapies is not frequently assessed, some evidence suggests that gains in functionality can last for at least [6][7][8][9][10][11][12] months after therapy in children with UCP. [25][26][27] .…”