A pilot study on early home-based intervention through an intelligent baby gym (CareToy) in preterm infants

Sgandurra, Giuseppina; Bartalena, Laura; Cecchi, Francesca; Cioni, Giovanni; Giampietri, Matteo; Greisen, Gorm; Herskind, Anna; Inguaggiato, Emanuela; Lorentzen, Jakob; Nielsen, Jens Bo; Orlando, Martina; Dario, P.

doi:10.1016/j.ridd.2016.01.013

Cited by 39 publications

(37 citation statements)

References 27 publications

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“…A previous pilot study confirmed both feasibility of the CareToy System as a tool in promoting EI in infants and validity of study design [16–17]. This Randomized Clinical Trial (RCT) study was aimed at testing short-term effects of CareToy training on motor and visual development in 3–9 month old preterm infants.…”

Section: Introductionmentioning

confidence: 80%

“…CareToy intervention (detailed in Sgandurra et al [12,16]) is an intensive, highly customized, home-based, family-centred training program, provided through remote management of a CareToy system delivered at home. It consists of specific goal-directed activities, called scenarios, remotely planned by the clinical/rehabilitative staff according to specific infant needs and capabilities.…”

Section: Methodsmentioning

confidence: 99%

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A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the 'CareToy System'

et al. 2017

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CareToy system is an innovative tele-rehabilitative tool, useful in providing intensive, individualized, home-based, family-centred Early Intervention (EI) in infants. Our aim was to evaluate, through a Randomized Clinical Trial (RCT) study, the effects of CareToy intervention on early motor and visual development in preterm infants. 41 preterm infants (range age: 3.0–5.9 months of corrected age) were enrolled and randomized into two groups, CareToy and Standard Care. 19 infants randomized in CareToy group performed a 4-week CareToy program, while 22 allocated to control group completed 4 weeks of Standard Care. Infant Motor Profile (IMP) was primary outcome measure, Alberta Infant Motor Scale (AIMS) and Teller Acuity Cards were secondary ones. Assessments were carried out at baseline (T0) and at the end of CareToy training or Standard Care period (T1). T1 was the primary endpoint. After RCT phase, 17 infants from control group carried out a 4-week CareToy program, while 18 infants from the CareToy group continued with Standard Care. At the end of this phase, infants were re-assessed at T2. In RCT phase, delta IMP total score and variation and performance sub-domains were significantly higher (P<0.050) in CareToy group if compared to Standard Care group. Similar results were found for Teller Acuity Cards, while no differences between groups were found for AIMS. No differences were found in any outcome measure results (T2-T0), between infants who started CareToy training before or after one month of standard care. This RCT study confirms the results of a previous pilot study, indicating that CareToy system can provide effective home-based EI.Trial Registration: This trial has been registered at www.clinicaltrials.gov (Identifier NCT01990183).

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Section: Introductionmentioning

confidence: 80%

Section: Methodsmentioning

confidence: 99%

A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the 'CareToy System'

et al. 2017

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“…The selected outcome measures demonstrate good correlation to clinical assessment scores, while the proposed training scenarios and goals are adequately designed to stimulate task-specific infant activity responses. A clinical pilot study 40 has recently additionally demonstrated that the CareToy system seems to be a feasible device for providing EI, but future work is needed to show if the CareToy system is able to provide a tele-rehabilitation program and detect changes through the training. It is expected that the proposed home environment-based stimulation and assessment system could, besides the ability of realistic toy play and natural environment, due to high accuracy, reliability, and objectivity of integrated sensor systems provide the opportunity i) to practice activities, more enjoyable than traditional therapy tasks, thereby encouraging training intensity through high trial repetitions and ii) to perform a family and child-centred approach, supporting them at implementation of the rehabilitation training.…”

Section: Discussionmentioning

confidence: 99%

CareToy: Stimulation and Assessment of Preterm Infant’s Activity Using a Novel Sensorized System

et al. 2016

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Early intervention programs aim at improving cognitive and motor outcomes of preterm infants. Intensive custom-tailored training activities are usually accompanied by assessment procedures, which have shortcomings, such as subjectivity, complex setups, and need for structured environments. A novel sensorized system, called CareToy, was designed to provide stimulation in the form of goal-directed activity training scenarios and motor pattern assessment of main developmental milestones, such as rolling activity, grasping, and postural stability. A group of 28 differently skilled preterm infants were enrolled. Acquired measurement data were analysed with dedicated sensor data processing algorithms, along with clinical evaluation of motor ability. High correlation among technically determined parameters and Alberta Infant Motor Scale values was determined by Pearson correlation coefficients. Due to good accuracy and possibility of single motor skill subfield analysis, results confirm system suitability for motor ability assessment. Statistical analysis of inter-motor ability group and inter-training goal data comparisons demonstrate system's appropriateness for goal-directed activity stimulation. The proposed system has evident potential of being an important contribution to the field of infant motor development assessment, expanding accessibility of early intervention programs and affecting rehabilitation effectiveness of preterm infants.

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“…Based on the chosen primary outcome measure, Infant Motor Profile (IMP [31],), and on IMP results of a pilot study and of previously conducted RCT in preterm infants without congenital brain lesions [15, 19, 20] and considering a 80% power and a significant level of 0.05 and a effect size of at least 0.6, a sample of 38 children is required. However, considering also a 10% of drop-out rate, a minimum of 42 infants will be required.…”

Section: Methodsmentioning

confidence: 99%

“…All children were assessed with specific and standardized scales and questionnaires, immediately before and immediately after treatment period. Results of the study showed that CareToy training has a positive effect on promoting short-term visual and motor infant’s development [19, 20]. …”

Section: Introductionmentioning

confidence: 99%

Early intervention at home in infants with congenital brain lesion with CareToy revised: a RCT protocol

Sgandurra

Beani

Giampietri³

et al. 2018

BMC Pediatr

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BackgroundCongenital brain lesions expose infants to be at high-risk for being affected by neurodevelopmental disorders such as cerebral palsy (CP). Early interventions programs can significantly impact and improve their neurodevelopment. Recently, in the framework of the European CareToy (CT) Project (www.caretoy.eu), a new medical device has been created to deliver an early, intensive, customized, intervention program, carried out at home by parents but remotely managed by expert and trained clinicians. Reviewing results of previous studies on preterm infants without congenital brain lesion, the CT platform has been revised and a new system created (CT-R).This study describes the protocol of a randomised controlled trial (RCT) aimed to evaluate, in a sample of infants at high-risk for CP, the efficacy of CT-R intervention compared to the Infant Massage (IM) intervention.Methods/designThis RCT will be multi-centre, paired and evaluator-blinded. Eligible subjects will be preterm or full-term infants with brain lesions, in first year of age with predefined specific gross motor abilities. Recruited infants will be randomized into CT-R and IM groups at baseline (T0). Based on allocation, infants will perform an 8-week programme of personalized CareToy activities or Infant Massage. The primary outcome measure will be the Infant Motor Profile. On the basis of power calculation, it will require a sample size of 42 infants. Moreover, Peabody Developmental Motor Scales-Second Edition, Teller Acuity Cards, standardized video-recordings of parent-infant interaction and wearable sensors (Actigraphs) will be included as secondary outcome measures. Finally, parents will fill out questionnaires (Bayley Social-Emotional, Parents Stress Index). All outcome measures will be carried out at the beginning (T0) and at end of 8-weeks intervention period, primary endpoint (T1). Primary outcome and some secondary outcomes will be carried out also after 2 months from T1 and at 18 months of age (T2 and T3, respectively). The Bayley Cognitive subscale will be used as additional assessment at T3.DiscussionThis study protocol paper is the first study aimed to test CT-R system in infants at high-risk for CP. This paper will present the scientific background and trial methodology.Trial registrationNCT03211533 and NCT03234959 (www.clinicaltrials.gov).

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A pilot study on early home-based intervention through an intelligent baby gym (CareToy) in preterm infants

Cited by 39 publications

References 27 publications

A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the 'CareToy System'

A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the 'CareToy System'

CareToy: Stimulation and Assessment of Preterm Infant’s Activity Using a Novel Sensorized System

Early intervention at home in infants with congenital brain lesion with CareToy revised: a RCT protocol

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