Study protocol for the Australasian Cerebral Palsy Musculoskeletal Health Network (AusCP MSK) prospective cohort study: early detection of musculoskeletal complications in young children with moderate to severe cerebral palsy (GMFCS III–V)

Abstract Background Cerebral palsy (CP) is the most common physical disability of childhood, affecting movement and posture, resulting from a neurological insult during pregnancy or the neonatal period. While the brain lesion is static, the musculoskeletal sequelae in CP are often progressive and lifelong, associated with pain and can impact the lives of children with CP, their families and the healthcare system. The Australasian Cerebral Palsy Musculoskeletal Health Network (AusCP MSK) study will conduct comprehensive, population-based surveillance of children with moderate to severe functional mobility limitations (Gross Motor Function Classification System (GMFCS) levels III–V) to explore the early biomarkers of, and interactions between, musculoskeletal complications related to CP, including hip displacement, scoliosis and skeletal fragility. Methods The AusCP MSK study involves three cohorts of children. Cohort A (n=500) is a multicentre retrospective (3 years) and prospective (4 years) cohort study in children aged 4–9 years that will be implemented at five sites across Australia and New Zealand. Retrospective data will include clinical history, information on CP diagnosis and other investigations (previous X-rays and biochemistry). Primary prospective outcomes will involve measures of hip displacement (migration percentage, acetabular index, femoral head orientation, Hilgenreiner’s epiphyseal angle), scoliosis (Anteroposterior/Posteroanterior and lateral spine X-ray), skeletal fragility (Dual Energy X-ray Absorptiometry, peripheral quantitative computed tomography), motor function (GMFCS, Manual Ability Classification System (MACS) and Communication Function Classification System (CFCS)) and range of movement (lower limb and spine). Cohort B (n=4000) is a retrospective analysis of data to evaluate fractures in children up to 18 years of age with CP (GMFCS I–V) from the New South Wales (NSW)/Australian Capital Territory CP Registers linked with corresponding records from NSW administrative health data (n=3000), and a New Zealand cohort of linked data from the New Zealand Cerebral Palsy Register to the Accident Compensation Corporation data for fracture claims (n=1000). Cohort C (n=30) will cross-sectionally examine bone quality through a transiliac bone biopsy in children undergoing scheduled hip surgery. Relationships between early biomarkers, early brain structure and musculoskeletal complications will be explored using multilevel mixed-effect models. Ethics and dissemination Ethical approval for this study was granted by Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee, The University of Queensland Human Research Ethics Committee and the New Zealand Health and Disability Ethics Committee. Research outcomes will be disseminated via scientific conferences and publications in peer-reviewed journals; to the National Bodies and Clinicians; and to people with CP and their families. Trial registration number Australian New Zealand Clinical Trials Registry number: ACTRN12622000788774p