Preterms at Risk for Developmental Disorders Clinical Trial
— CareToyOfficial title:
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.
| Status | Completed |
| Enrollment | 44 |
| Est. completion date | December 2015 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 3 Months to 9 Months |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Helene Elsass Center | Holmegaardsvej 28 | Charlottenlund |
| Italy | IRCCS Stella Maris Foundation | Calambrone | Pisa |
| Lead Sponsor | Collaborator |
|---|---|
| IRCCS Fondazione Stella Maris | BioRobotics Institute - Scuola Superiore Sant'Anna, Italy, Fonden for Helen Elsass Center, Denmark, Marketing Research & Development SPA, Italy, STMicroelectronics SRL, Italy, University of Hamburg, University of Ljubljana |
Denmark, Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Ages & Stages Questionnaire (ASQ) | 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. |
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) | No |
| Other | Social - Emotional Scale of BSID-III | 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. | 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) | No |
| Other | Parenting Stress Index (PSI) | 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 | 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) | No |
| Primary | 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 | No |
| Secondary | Changes on Alberta Infant Motor Scale (AIMS) | 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. | 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) | No |
| Secondary | CareToy for Clinics (CareToy C) | 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. | 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) | No |
| Secondary | Changes on Teller Acuity Cards | 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. | 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) | No |
| Secondary | Changes on Bayley III - Cognitive subscale | 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. | T0 (baseline, 1week before beginning of Study period);T3: 18 months of Corrected Age (CA) | No |