CareToy - A Modular Smart System for Infants' Rehabilitation at Home Based on Mechatronic Toys

NACompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

April 30, 2015

Study Completion Date

December 31, 2015

Conditions
Preterms at Risk for Developmental Disorders
Interventions
DEVICE

CareToy

Infants randomized in the Intervention Group will begin the habilitation intervention immediately after evaluation at baseline. Rehabilitation staff, in accordance with each infant's needs and clinical characteristics, will set up the CareToy System to perform individualized intervention packages and its user's manual. So a personalized CareToy System will be delivered at infant's home. Moreover parents will attend a training course to use it. During each daily home - session (about 30 - 45 minutes overall) it will be proposed to the child various interactive activities in supine, prone and sitting position. The intervention phase lasts 4 weeks and each session will be remotely monitored by the rehabilitation staff.

OTHER

Standard Care

Current care advices in the management of preterm infants in the first months of life

Trial Locations (2)

2920

Helene Elsass Center, Holmegaardsvej 28

56128

IRCCS Stella Maris Foundation, Calambrone

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

BioRobotics Institute

OTHER

collaborator

STMicroelectronics SRL, Italy

UNKNOWN

collaborator

University of Ljubljana

OTHER

collaborator

University of Hamburg-Eppendorf

OTHER

collaborator

Fonden for Helen Elsass Center, Denmark

UNKNOWN

collaborator

Marketing Research & Development SPA, Italy

UNKNOWN

lead

IRCCS Fondazione Stella Maris

OTHER

NCT01990183 - CareToy - A Modular Smart System for Infants' Rehabilitation at Home Based on Mechatronic Toys | Biotech Hunter | Biotech Hunter