CareToy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Study population will be made up of premature infants recruited at the local Department of Neonatology. The eligibility of infants, i.e. children who meet the criteria for inclusion and exclusion, will be evaluated by the Neonatology team. Recruitment should take place after discharge from Neonatal Intensive Care Unit (NICU) until the age stated by inclusion criteria and will begin with the signing of the participation agreement by the parents. During the recruitment extensive perinatal data will be collected from medical records. Each clinical centre will maintain these data in an internal database storing. Every child will be evaluated on the basis of a standard neurological examination supplemented by movement analysis on video recording using Prechtl's Method Qualitative Assessment of General Movements.

The sample will be randomized in two groups in order to compare the effectiveness of the CareToy intervention program vs standard care on motor, cognitive and visual development. We designed the study as randomized clinical trial. The sample size was calculated on the basis of the primary outcome measure (Infant Motor Profile \[IMP\], see Outcome measures).

Before the starting of the RCT we have planned a short pilot phase where few infants in order to assess the feasibility of the CareToy training and to tune and set-up the CareToy system and the rehabilitation packages. These cases will follow the same steps planned for the RCT.

Conditions

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Preterms at Risk for Developmental Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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CareToy intervention

Group Type EXPERIMENTAL

CareToy

Intervention Type DEVICE

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.

Standard Care

Group Type OTHER

Standard Care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DEVICE

Standard Care

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

3 Months

Maximum Eligible Age

9 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes