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

NCT01990183 | Completed DMC

• 1 other identifier: ICT-2011.5.1-287932
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 2

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.

Conditions

Preterms at Risk for Developmental Disorders

Keywords

preterm infants; early intervention; enrichment; cognitive, motor, visual development; tele-rehabilitation

Outcome Measures

Primary Outcomes (1)

• Changes on Infant Motor Profile (IMP)

  IMP is a reliable video-based assessment of motor behaviour in infancy from 3 to 18 months. It addresses to the child's motor abilities and evaluates motor behaviour in five domains: (1) variation, (2) variability (ability to select motor strategies), (3) movement fluency, (4) movement symmetry, and (5) motor performance. It has been validated in preterm and full term infants. This tool is intended to detect and quantify changes after intervention and it is reported as having a satisfactory intra and inter observer reliability and a very good concurrent validity with Alberta Infant Motor Scale and Touwen Infant Neurological Examination.

  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

Secondary Outcomes (4)

• Changes on Alberta Infant Motor Scale (AIMS)

  T0 (baseline,1wk before beginning of Study period);T1(within 1 wk after end of 1st training/control period; before cross-over);T2 (within 1wk after end of 2nd training/control 2nd period, after cross-over) T3 (18 mths of corrected age)

• CareToy for Clinics (CareToy C)

  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)

• Changes on Teller Acuity Cards

  T0 (baseline,1wk before beginning of Study period);T1(within 1 wk after end of 1st training/control period; before cross-over);T2 (within 1wk after end of 2nd training/control 2nd period, after cross-over) T3 (18 mths of corrected age)

• Changes on Bayley III - Cognitive subscale

  T0 (baseline, 1week before beginning of Study period);T3: 18 months of Corrected Age (CA)

Other Outcomes (3)

• Ages & Stages Questionnaire (ASQ)

  T0 (baseline,1wk before beginning of Study period);T1(within 1 wk after end of 1st training/control period; before cross-over);T2 (within 1wk after end of 2nd training/control 2nd period, after cross-over); T3 (18 mths of corrected age)

• Social - Emotional Scale of BSID-III

  T0 (baseline,1wk before beginning of Study period);T1(within 1 wk after end of 1st training/control period; before cross-over);T2 (within 1wk after end of 2nd training/control 2nd period, after cross-over); T3 (18 mths of corrected age)

• Parenting Stress Index (PSI)

  T0 (baseline,1wk before beginning of Study period);T1(within 1 wk after end of 1st training/control period; before cross-over);T2 (within 1wk after end of 2nd training/control 2nd period, after cross-over) T3 (18 mths of corrected age)

Study Arms (2)

CareToy

EXPERIMENTAL

CareToy intervention

Device: CareToy

Standard Care

OTHER

Standard Care

Other: Standard Care

Interventions

CareToy 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.

CareToy

Standard Care OTHER

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

Standard Care

Eligibility Criteria

• Age: 3 Months - 9 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• months form (from 3 months to 4 months 30 days) score ≥ 10;
• months form (from 5 months to 6 months 30 days) score ≥ 5 - \< 50;
• months form (from 7 months to 8 months 30 days) ≥ 10 - \<30

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead
• BioRobotics Institute: collaborator
• STMicroelectronics SRL, Italy: collaborator
• University of Ljubljana: collaborator
• University of Hamburg-Eppendorf: collaborator
• Fonden for Helen Elsass Center, Denmark: collaborator
• Marketing Research & Development SPA, Italy: collaborator

Study Sites (2)

Helene Elsass Center

Holmegaardsvej 28, Charlottenlund, 2920, Denmark

Location

IRCCS Stella Maris Foundation

Calambrone, Pisa, 56128, Italy

Location

Related Publications (4)

• Rizzi R, Menici V, Cioni ML, Cecchi A, Barzacchi V, Beani E, Giampietri M, Cioni G, Sgandurra G; Clinical CareToy-R Consortium. Concurrent and predictive validity of the infant motor profile in infants at risk of neurodevelopmental disorders. BMC Pediatr. 2021 Feb 6;21(1):68. doi: 10.1186/s12887-021-02522-5.

  PMID: 33549070 DERIVED

• Sgandurra G, Beani E, Inguaggiato E, Lorentzen J, Nielsen JB, Cioni G. Effects on Parental Stress of Early Home-Based CareToy Intervention in Low-Risk Preterm Infants. Neural Plast. 2019 Jan 22;2019:7517351. doi: 10.1155/2019/7517351. eCollection 2019.

  PMID: 30804992 DERIVED

• Sgandurra G, Lorentzen J, Inguaggiato E, Bartalena L, Beani E, Cecchi F, Dario P, Giampietri M, Greisen G, Herskind A, Nielsen JB, Rossi G, Cioni G; CareToy Consortium. A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the 'CareToy System'. PLoS One. 2017 Mar 22;12(3):e0173521. doi: 10.1371/journal.pone.0173521. eCollection 2017.

  PMID: 28328946 DERIVED

• Sgandurra G, Bartalena L, Cioni G, Greisen G, Herskind A, Inguaggiato E, Lorentzen J, Nielsen JB, Sicola E; CareToy Consortium. Home-based, early intervention with mechatronic toys for preterm infants at risk of neurodevelopmental disorders (CARETOY): a RCT protocol. BMC Pediatr. 2014 Oct 15;14:268. doi: 10.1186/1471-2431-14-268.

  PMID: 25319764 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 21, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 12, 2016

Record last verified: 2016-02

Locations

DK (1); IT (1)