Completed

NCT Number: NCT01990183

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

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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Key information

Conditions

Preterms at Risk for Developmental Disorders

Age range

3 month–9 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helene Elsass Center, Holmegaardsvej 28, Charlottenlund, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard care

Other

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

Primary outcomes

Changes on Infant Motor Profile (IMP)

Time frame: 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

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.

Secondary outcomes

Changes on Alberta Infant Motor Scale (AIMS)

Time frame: 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)

This scale examines delayed and abnormal motor development in infants overtime and is valid for assessment from term until 18 months of age. It has a good psychometric properties, it is quick to administer with limited handling and focuses on achievement of motor milestones, quality of posture and movement outcomes. Sensitivity of AIMS items has been demonstrated in differentiate preterm's infant motor development, that typically results in lower scores, and full term infants motor development.
CareToy for Clinics (CareToy C)

Time frame: 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)

CareToy Evaluation Packages will be carried out using a highly equipped system, called Caretoy C in a subgroup of the enrolled infants. This evaluation is mainly composed by visual packages designed to evaluate some different infants visual abilities i.e. attention, audio-visual, fixation shift and novelty.
Changes on Teller Acuity Cards

Time frame: 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)

Teller Acuity Cards II is a paediatric test used to evaluate visual acuity. It is based on behavioural response by judging infant's attention to a series of cards showing stripes of different widths. This tool allows rapid assessment of resolution (grating) visual acuity in infants, young children, and other populations where verbal response to recognition (letter) visual acuity charts is difficult or impossible. It evaluates infants' acuity development and it has been used in several studies for diagnostic purposes and to measure results of early intervention.
Changes on Bayley III - Cognitive subscale

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

his scale is sensitive in detecting differences between normative sample and children at risk for delayed development, such as premature infants. It has normative value referenced assessments, with means of 100 and Standard Deviation [SD] of 15 points. Children whose scores are 2 SDs below the normative value in a domain are considered as having a significant delay in that domain. Bayley---III is appropriate for administration to children between the ages of 1 month and 42 months (although norms extend downward to age 16 days). The Bayley III revision includes Cognitive, Language, Motor, Social-Emotional, and Adaptive Behaviour scales. Items on the cognitive subscale assess sensor-motor development, exploration, manipulation, object relatedness, concept formation, problem-solving and memory, all functions promoted during the CareToy sessions.

Other outcomes

Ages & Stages Questionnaire (ASQ)

Time frame: 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)

It has been developed as a screening tool for developmental delay in infants in numerous paediatric populations with reported sensitivity, a measure of true positives, and specificity, a measure of true negatives, varying, with most studies reporting higher accuracy in at - risk populations.

This questionnaire will be given to parents after enrolment in order to define the most appropriate starting time for each infant.
Social - Emotional Scale of BSID-III

Time frame: 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)

The survey uses this observational rating scale that provides a general indication of the infant's level of social- emotional development and information about whether or not sensory processing difficulties are present.
Parenting Stress Index (PSI)

Time frame: 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)

This is a self-report questionnaire designed to identify specific parental, child, and situational characteristics most commonly associated with dysfunctional parenting. Currently, the PSI is mostly used as a screening instrument for early identification of parent- child systems, which are under stress and at risk of developing dysfunctional parenting behaviour. Validity of PSI is good and has been established in numerous studies on children with developmental problems, behaviour problems, disabilities and illnesses, as well as studies of at- risk families, and cross - cultural studies

Sponsors and collaborators

Lead sponsor

IRCCS Fondazione Stella Maris

Other

Collaborators

BioRobotics Institute
Fonden for Helen Elsass Center, Denmark
Marketing Research & Development SPA, Italy
STMicroelectronics SRL, Italy
University of Hamburg-Eppendorf
University of Ljubljana

Registry information

Acronym: CareToy

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Nov 21, 2013
Registry last updated: Feb 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.