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      Feasibility Analysis of CareToy-Revised Early Intervention in Infants at High Risk for Cerebral Palsy

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          Abstract

          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.

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          A tutorial on pilot studies: the what, why and how

          Pilot studies for phase III trials - which are comparative randomized trials designed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas. Also commonly know as "feasibility" or "vanguard" studies, they are designed to assess the safety of treatment or interventions; to assess recruitment potential; to assess the feasibility of international collaboration or coordination for multicentre trials; to increase clinical experience with the study medication or intervention for the phase III trials. They are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite. Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies. The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including: 1) the general reasons for conducting a pilot study; 2) the relationships between pilot studies, proof-of-concept studies, and adaptive designs; 3) the challenges of and misconceptions about pilot studies; 4) the criteria for evaluating the success of a pilot study; 5) frequently asked questions about pilot studies; 7) some ethical aspects related to pilot studies; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format.
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            The path to personalized medicine.

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              An update on the prevalence of cerebral palsy: a systematic review and meta-analysis.

              The aim of this study was to provide a comprehensive update on (1) the overall prevalence of cerebral palsy (CP); (2) the prevalence of CP in relation to birthweight; and (3) the prevalence of CP in relation to gestational age. A systematic review and meta-analysis was conducted and reported, based on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) statement. Population-based studies on the prevalence of CP in children born in 1985 or after were selected. Statistical analysis was carried out using computer package R, version 2.14. A total of 49 studies were selected for this review. The pooled overall prevalence of CP was 2.11 per 1000 live births (95% confidence interval [CI] 1.98-2.25). The prevalence of CP stratified by gestational age group showed the highest pooled prevalence to be in children weighing 1000 to 1499g at birth (59.18 per 1000 live births; 95% CI 53.06-66.01), although there was no significant difference on pairwise meta-regression with children weighing less than 1000g. The prevalence of CP expressed by gestational age was highest in children born before 28 weeks' gestation (111.80 per 1000 live births; 95% CI 69.53-179.78; p<0.0327). The overall prevalence of CP has remained constant in recent years despite increased survival of at-risk preterm infants. © The Authors. Developmental Medicine & Child Neurology © 2013 Mac Keith Press.
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                Author and article information

                Contributors
                Journal
                Front Neurol
                Front Neurol
                Front. Neurol.
                Frontiers in Neurology
                Frontiers Media S.A.
                1664-2295
                16 December 2020
                2020
                : 11
                : 601137
                Affiliations
                [1] 1Department of Developmental Neuroscience, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Fondazione Stella Maris , Pisa, Italy
                [2] 2Division of Neonatology, Careggi University Hospital, University of Florence , Florence, Italy
                [3] 3Neonatal Intensive Care Unit, Children's Hospital A. Meyer , Florence, Italy
                [4] 4Neonatal Intensive Care Unit, Pisa University Hospital Santa Chiara , Pisa, Italy
                [5] 5Tuscan Ph.D. Programme of Neuroscience, University of Florence , Florence, Italy
                [6] 6Department of Clinical and Experimental Medicine, University of Pisa , Pisa, Italy
                Author notes

                Edited by: Paolo Tonin, Sant'Anna Institute, Italy

                Reviewed by: Elisa Hamer, University Medical Center Groningen, Netherlands; Elisa Di Giorgio, University of Padua, Italy

                *Correspondence: Giuseppina Sgandurra g.sgandurra@ 123456fsm.unipi.it

                This article was submitted to Neurorehabilitation, a section of the journal Frontiers in Neurology

                Article
                10.3389/fneur.2020.601137
                7772394
                33391164
                8551846e-a645-4ab8-a8fe-be0325c3d357
                Copyright © 2020 Beani, Menici, Cecchi, Cioni, Giampietri, Rizzi, Sgandurra, Cioni and CareToy-R Consortium.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 31 August 2020
                : 04 November 2020
                Page count
                Figures: 3, Tables: 8, Equations: 0, References: 44, Pages: 13, Words: 9104
                Categories
                Neurology
                Original Research

                Neurology
                early intervention,tele-rehabilitation,caretoy,information and communication technologies,infants,cerebral palsy

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