CompletedNot Applicable

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

Denmark, Italy44 participantsStarted 2013-07

Plain-language 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.

Who can participate

Age range

3 Months – 9 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * gestational age ≥ 28+0 weeks and 32+6 weeks * corrected age at baseline: between 3 and 9 months; * achievement of predefined cut off scores in gross motor ability derived from Ages \& Stages Questionnaire® Third Edition (ASQ-3), in relation to corrected age (Bricker and Squires, 1999) In detail: * 4 months form (from 3 months to 4 months 30 days) score ≥ 10; * 6 months form (from 5 months to 6 months 30 days) score ≥ 5 - \< 50; * 8 months form (from 7 months to 8 months 30 days) ≥ 10 - \<30 Exclusion Criteria: * infants with gestational age \< 28 weeks or ≥ 33 weeks * infants small for gestational age (i.e. weight below the 10th, ref) * presence of brain damage (i.e. brain malformation, intra-ventricular haemorrhage \[IVH\] \>1 ; any degree of periventricular leukomalacia (ref) * known epilepsy or other form of seizure * severe sensory deficits (blindness, deafness) * other severe non neurological malformations * participation in other experimental studies having rehabilitation aims

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes on Infant Motor Profile (IMP)

Timeframe: T0(baseline, 1week before beginning of Study period);T1 (within 1 week after the end of the first training/control period; before the cross-over); T2 (within 1 week after the end of the second training/control 2nd period, after cross-over), T3: 18 months

Trial details

NCT IDNCT01990183

SponsorIRCCS Fondazione Stella Maris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-04

View on ClinicalTrials.gov More Preterms at Risk for Developmental Disorders trials