CareToy Early Intervention in Infants at Risk for Cerebral Palsy

Cerebral Palsy (CP), due to pre-perinatal brain lesions, is a main cause of childhood disabilities with high cost for individuals and society. Early Intervention (EI), if intensive enough but affordable by patients, family and health services can improve its outcome. A recent Cochrane review indicates the positive effects of Infant Massage (IM) in gross and fine motor skills, visual development and parent infants interaction in preterm infants. Recently, a new technological tool, called CareToy has been developed as a tele-rehabilitation tool for delivering at home EI. The effects of CT training on neurodevelopmental outcome have been recently tested in a sample of low-risk preterm infants with very promising results. The aim of the project is to provide evidence, by a RCT, of the efficacy of CareToy (CT) training versus Infant Massage, in a sample of 45 infants aged 3-12 months (or with motor competencies from initial head control to unstable sitting position) at high risk for CP according to strict clinical and neuroradiological signs. Enrolled infants will be randomized in 2 groups: CareToy and Infant Massage. Infants allocated in CT group will perform a training with CT while the others will perform infant massage. Both trainings will be carried out at home by parents with the monitoring of the therapists. Both interventions will last 8 weeks. All enrolled infants will be evaluated at baseline (T0),9 wks after the CT/IM (T1), 9 wks after T1 (T2) and at 18 months of post term age (T3). Infant Motor Profile will be the primary outcome measure.