Infants with perinatal brain injury are at high risk for Cerebral Palsy (CP). Progresses in detection of early signs of brain injury and of CP allow early intervention (EI) programs for improving the outcome of these infants. CareToy system (CT), developed within a European project (Trial Registration: NCT01990183), allows providing, by means of tele-rehabilitation, a highly personalized, family-centered, home-based EI for young infants, remotely managed by clinicians. CareToy, already used with pre-terms without brain injury, has been adapted for high-risk infants in a project funded by the Italian Ministry of Health, and the CareToy-Revised (CareToy-R) has been realized (Trial registration: NCT03211533 and NCT03234959). Before assessing its efficacy, it was crucial to evaluate the acceptability, usability, and feasibility of CareToy-R EI. Nineteen high-risk infants with perinatal brain injury, aged 5.95 ± 2.13 months (range 3.12–10.78 months), carried out an 8-week training with CareToy-R at home, performing customized playful activities with their parents, tailored to their rehabilitative needs, remotely managed by clinicians. The feasibility of training and study procedures was assessed through criteria derived from literature; acceptability and usability have been analyzed from data about individual training and an ad hoc questionnaire. All CareToy-R trainings were planned by the clinical staff with a daily personalized use for each infant between 30 and 45 min (mean 34.37 min). The amount of executed training by the infants was very high (daily mean 30.30 min), with no differences related to infant age, sex, and gestational age. All the nine feasibility criteria were achieved, family compliance to the project was very good, data collection was completed and the CareToy-R system worked properly and easily for parents. The answers to the questionnaire had a total mean score of 84.49% and they ranged from a minimum of 81.05% (in “easy to use” area) to a maximum of 86.49% (“changes due to the training” area), with no differences related to nationality or familiarity with technology of the mothers. This study reports preliminary evidence to the feasibility of a home-based EI with CareToy-R system in infants at high risk for CP. Results of the RCT will provide data about the potential effectiveness of this approach.
Abstract Background: Preterm infants and infants with perinatal brain injury show higher incidence of neurodevelopmental disorders (NDD). The Infant Motor Profile (IMP) is a clinical assessment which evaluates the complexity of early motor behaviour. More data are needed to confirm its predictive ability and concurrent validity with other common and valid assessments such as the Alberta Infant Motor Profile (AIMS) and the Prechtl’s General Movement Assessment (GMA). The present study aims to evaluate the concurrent validity of IMP with AIMS, to assess its association with GMA, to evaluate how IMP reflects the severity of the brain injury and to compare the ability of IMP and AIMS to predict abnormal outcome in 5-months infants at risk of NDD. Methods: 86 infants at risk of NDD were retrospectively recruited among the participants of two clinical trials. Preterm infants with or without perinatal brain injury and term infants with brain injury were assessed at 3 months corrected age (CA) using GMA and at 5 months CA using IMP and AIMS. Neurodevelopmental outcome was established at 18 months. Results: Results confirm a solid concurrent validity between IMP and AIMS (Spearman’s ρ 0.76; p<.001) and significant association between IMP and GMA. Unlike AIMS, IMP Total score accurately reflects the severity of neonatal brain injury (p<.001) and results to be the strongest predictor of NDD (p<.001). Confrontation of areas under receiver operating characteristic curves (AUC) confirms that IMP Total score has the highest diagnostic accuracy at 5 months (AUC 0.92). For an optimal IMP cut-off value of 70, the assessment shows high sensitivity (93%) and specificity (81%) (PPV 84%; NPV 90%). Conclusions: Early motor behaviour assessed with IMP is strongly associated with middle-term neurodevelopmental outcome. The present study confirms the concurrent validity of IMP with AIMS, its association with GMA and its ability to reflect brain lesion load contributing to the construct validity of the assessment. Trial registration: NCT01990183 and NCT03234959 (clinicaltrials.gov)
