Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: CareToy: a Smart System for Early Home-based Intervention in Infants at High Risk for Cerebral Palsy
Brief Summary: 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.


Options:
A: Arm Label: Early stimulation; Type: EXPERIMENTAL; Interventions: Other: Early stimulation | Arm Label: Conventional care; Type: ACTIVE_COMPARATOR; Interventions: Other: Conventional care | Intervention Type: OTHER; Name: Early stimulation; Assigned to Arm(s): Early stimulation | Intervention Type: OTHER; Name: Conventional care; Assigned to Arm(s): Conventional care
B: Arm Label: Term group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Usual care program group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Clinic-based interveniton program group; Type: EXPERIMENTAL; Interventions: Behavioral: clinic-based intervention program and home-based intervention program | Arm Label: Home-based interveniton program group; Type: EXPERIMENTAL; Interventions: Behavioral: clinic-based intervention program and home-based intervention program | Intervention Type: BEHAVIORAL; Name: clinic-based intervention program and home-based intervention program; Assigned to Arm(s): Clinic-based interveniton program group, Home-based interveniton program group
C: Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: SPEEDI_Early; Type: EXPERIMENTAL; Interventions: Behavioral: Supporting Play Exploration and Developmental Intervention (SPEEDI) | Arm Label: SPEEDI_Late; Type: EXPERIMENTAL; Interventions: Behavioral: Supporting Play Exploration and Developmental Intervention (SPEEDI) | Intervention Type: BEHAVIORAL; Name: Supporting Play Exploration and Developmental Intervention (SPEEDI); Assigned to Arm(s): SPEEDI_Early, SPEEDI_Late
D: Arm Label: CareToy Intervention; Type: EXPERIMENTAL; Interventions: Device: CareToy intervention | Arm Label: Infant Massage; Type: ACTIVE_COMPARATOR; Interventions: Other: Infant Massage | Intervention Type: DEVICE; Name: CareToy intervention; Assigned to Arm(s): CareToy Intervention | Intervention Type: OTHER; Name: Infant Massage; Assigned to Arm(s): Infant Massage

Answer: D