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

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.

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

Sponsors & Collaborators

• BioRobotics Institute

  collaborator OTHER

• STMicroelectronics SRL, Italy

  collaborator UNKNOWN

• University of Ljubljana

  collaborator OTHER

• University of Hamburg-Eppendorf

  collaborator OTHER

• Fonden for Helen Elsass Center, Denmark

  collaborator UNKNOWN

• Marketing Research & Development SPA, Italy

  collaborator UNKNOWN

• IRCCS Fondazione Stella Maris

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

9 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-07-31

Primary Completion

2015-04-30

Completion

2015-12-31

Countries

• Denmark
• Italy

Study Locations