Home based early intervention with CareToy-Revised in infants with early brain injury: a randomized controlled trial.

Introduction: Intensive, family-centered early intervention (EI) may support neurodevelopment during a period of high neuroplasticity in infants with perinatal brain injury who are at high risk of cerebral palsy (CP). CareToy-Revised (CT-R) is a smart, home-based, parent-delivered system that provides individualized, goal-directed EI. Aims: To determine the effects of CT-R on early motor development of infants with brain injury, thus at high risk of developing CP, comparing it with another known EI, namely the Infant Massage (IM). Methods: Thirty-eight infants with perinatal brain injury, at high risk of cerebral palsy (CT-R Results: The groups presented no significant differences at baseline. At T1, the CT-R group showed significantly higher IMP raw scores for total score, symmetry, and performance than the IM group. For PDMS-2, TAC, and BSID-III cognition, no significant between-group differences were found. After adjustment for covariates, CT-R showed effectiveness at T1 across the IMP domains (total Discussion: CT-R significantly improved the early motor development of infants with early brain injury, supporting the potential value of intensive, individualized, home-based, and parent-delivered EI. Clinical Trial Registration: NCT03234959 on ClinicalTrials.gov.