Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: CareToy - A Modular Smart System for Infants' Rehabilitation at Home Based on Mechatronic Toys
Brief Summary: Stroke and other neurological conditions affect the population of infants in percentages that cannot be considered marginal. Preterm infants are the highest infants at risk for neurological damage. Currently, infants have rehabilitation sessions few times a week in rehabilitation centres but according to basic neuroscience it would be necessary to provide them with an early, intensive and multiaxial intervention. One option to reduce the cost of the entire European Healthcare System while increasing the practice of rehabilitation is to devise therapies and technologies that can be administered at home by caregivers and telemonitored by rehabilitation staff. The aim of this proposal is to promote early intervention in the first year of life and to reinforce therapy by "CareToy": a portable low cost smart system telemonitored thus augmenting the clinical effectiveness of the therapy while reducing the cost. The smart system is based on a common baby gym, composed of different modules: a) an instrumented baby gym with mechatronic hanging toys, so that the infants' actions on the gym can be measured and stimulated, b) a vision module, for measuring and promoting infants' attention and gaze movements and c) a sensorized mat for measuring and promoting postural control. Each module will also incorporate built-in signal processor, memory and wireless communication. A fourth telerehabilitation module completes the system that allows the system to remotely communicate with the rehabilitation staff for monitoring and assessing the rehabilitation techniques. CareToy and the effectiveness of home rehabilitation based on this system will be validated by clinical trials on at least 50 preterm infants. The result of this project could have a large impact. CareToy may become a commercial product, manufactured on a large scale and distributed not only in rehabilitation centres but also at homes, sold or rented by the Health Care System to families as a therapeutic tool for care intensity.


Options:
A: Arm Label: MT during and after NICU; Type: EXPERIMENTAL; Interventions: Behavioral: MT during NICU, Behavioral: MT after NICU, Other: Standard care | Arm Label: MT during NICU; Type: EXPERIMENTAL; Interventions: Behavioral: MT during NICU, Other: Standard care | Arm Label: MT after NICU; Type: EXPERIMENTAL; Interventions: Behavioral: MT after NICU, Other: Standard care | Arm Label: No MT; Type: EXPERIMENTAL; Interventions: Other: Standard care | Intervention Type: BEHAVIORAL; Name: MT during NICU; Assigned to Arm(s): MT during NICU, MT during and after NICU | Intervention Type: BEHAVIORAL; Name: MT after NICU; Assigned to Arm(s): MT after NICU, MT during and after NICU | Intervention Type: OTHER; Name: Standard care; Assigned to Arm(s): MT after NICU, MT during NICU, MT during and after NICU, No MT
B: Arm Label: Phase 1: Standard Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Phase 1: Facilitated infant care; Type: EXPERIMENTAL; Interventions: Behavioral: Family Nurture Intervention | Arm Label: Phase 2: Effectiveness; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Family Nurture Intervention | Intervention Type: BEHAVIORAL; Name: Family Nurture Intervention; Assigned to Arm(s): Phase 1: Facilitated infant care, Phase 2: Effectiveness
C: Intervention Type: BEHAVIORAL; Name: Sensitizing parents; Assigned to Arm(s): N/A
D: Arm Label: CareToy; Type: EXPERIMENTAL; Interventions: Device: CareToy | Arm Label: Standard Care; Type: OTHER; Interventions: Other: Standard Care | Intervention Type: DEVICE; Name: CareToy; Assigned to Arm(s): CareToy | Intervention Type: OTHER; Name: Standard Care; Assigned to Arm(s): Standard Care

Answer: D