Clinical Trials

We are optimising neuroplasticity because the brain’s capacity to recover after injury is what makes early rehabilitation scientifically possible. Neuroplasticity encompasses the ability of the brain to organize/reorganize its circuitry and produce new cells (neurogenesis) and connections (synaptogenesis) combined with environmental stimulation and enrichment protects neurons and promotes the secretion of growth factors in the brain.

The CRE team build on their strong track records undertaking RCTs of interventions for infants/children with CP and their families. CRE members have undertaken many of the largest RCTs in rehabilitation, prevention of hip displacement, pharmacology to reduce spasticity and early interventions. Our strong track records in epidemiological studies and population-based cohort studies enable development of international trials. Our links to CP registers will enable us to test the changes in neurodevelopment and school readiness outcomes for children with CP identified earlier, who received neuroprotectants & earlier neuro-rehabilitation.

Current Projects in this theme:

Cell Therapies Clinical Trials - 

  • SCUBI Trial - Phase 1 Safety trial of sibling-matched UCB for cerebral palsy
  • CORD-SAFE: Autologous umbilical cord blood derived cells in EPT infants
  • Using genomics to define the response to stem cell therapy

Phase II Clinical Trials, RCTs of New Interventions - 

  • RCT of Erythropoietin (EPO) for CP
  • SuPreme: Neuroprotective role of sulphate among preterm babies
  • GAME: Harnessing Neuroplasticity: RCT Goal-directed Motor Enrichment for infant CP
  • EARLY PACT: Parenting Acceptance and Commitment Therapy: RCT of a web-based intervention for parents of infants diagnosed early with CP
  • PROTECT Me: RCT of Antenatal Melatonin Supplementation in Fetal Growth Restriction for Fetal Neuroprotection
  • REACH: Randomised trial Rehabilitation EArly for Congenital Hemiplegia
  • VISIBLE: Randomised trial Early Intervention for Seeing Impaired babies
  • LEAP-Indigenous Trial: Learning through Everyday Activities with Parents for Aboriginal and Torres Strait Islander infants at risk of adverse neurodevelopmental outcomes
  • HABIT-ILE: RCT of Hand Arm Bimanual Intensive Training Including Lower Extremity training for children with bilateral CP
  • Preschool HABIT-ILE: RCT for 2-to-5 year old children with bilateral CP
  • ParticiPAte CP: Optimising participation in physically active leisure for children with CP: A multisite RCT.
  • Liberty Trial: Pre-post trial of Closed Loop direct spinal cord stimulation to reduce spasticity and improve function in children with CP
  • ACTIVE STRIDES CP: RCT of Intensive Rehabilitation (Combined Intensive Gait & Cycling Training) for children with moderate to severe CP.
  • The Friends Project: Efficacy of telehealth delivered social skills training for ABI/CP.

Clinical and Population Based Longitudinal Studies - 

 

 

Past clinical trials and RCTs in this theme:

  • Botulinum toxin-A on muscle structure/function in children with CP.
  • Preventing Adverse Outcomes of Neoantal Hypoxic Ischaemic Encephalopathy with Erythropoeitin: A Randomised Controlled Multicentre Australian Trial. (PAEAN Trial)
  • RCT of a parenting program for parents of very preterm infants. (Prem Baby Triple P)
  • Parenting Acceptance and Commitment Therapy (PACT): a trial of an innovative web-based intervention for parents of children with cerebral palsy. (PACT)