The wide world of technological telerehabilitation for pediatric neurologic and neurodevelopmental disorders - a systematic review.

Introduction: The use of Information and Communication Technology (ICT) for assessing and treating cognitive and motor disorders is promoting home-based telerehabilitation. This approach involves ongoing monitoring within a motivating context to help patients generalize their skills. It can also reduce healthcare costs and geographic barriers by minimizing hospitalization. This systematic review focuses on investigating key aspects of telerehabilitation protocols for children with neurodevelopmental or neurological disorders, including technology used, outcomes, caregiver involvement, and dosage, to guide clinical practice and future research. Method: This systematic review adhered to PRISMA guidelines and was registered in PROSPERO. The PICO framework was followed to define the search strategy for technology-based telerehabilitation interventions targeting the pediatric population (aged 0-18) with neurological or neurodevelopmental disorders. The search encompassed Medline/PubMed, EMBASE, and Web of Science databases. Independent reviewers were responsible for selecting relevant papers and extracting data, while data harmonization and analysis were conducted centrally. Results: A heterogeneous and evolving situation emerged from our data. Our findings reported that most of the technologies adopted for telerehabilitation are commercial devices; however, research prototypes and clinical software were also employed with a high potential for personalization and treatment efficacy. The efficacy of these protocols on health or health-related domains was also explored by categorizing the outcome measures according to the International Classification of Functioning, Disability, and Health (ICF). Most studies targeted motor and neuropsychological functions, while only a minority of papers explored language or multi-domain protocols. Finally, although caregivers were rarely the direct target of intervention, their role was diffusely highlighted as a critical element of the home-based rehabilitation setting. Discussion: This systematic review offers insights into the integration of technological devices into telerehabilitation programs for pediatric neurologic and neurodevelopmental disorders. It highlights factors contributing to the effectiveness of these interventions and suggests the need for further development, particularly in creating dynamic and multi-domain rehabilitation protocols. Additionally, it emphasizes the importance of promoting home-based and family-centered care, which could involve caregivers more actively in the treatment, potentially leading to improved clinical outcomes for children with neurological or neurodevelopmental conditions. Systematic review registration: PROSPERO (CRD42020210663).

Neuroanatomical correlates of gross manual dexterity in children with unilateral spastic cerebral palsy.

Unilateral spastic Cerebral Palsy (UCP) results from congenital brain injury, and Magnetic Resonance Imaging (MRI) has a role in understanding the etiology and severity of brain insult. In UCP, functional impairment predominantly occurs in the upper limb (UL) of the more affected side, where manual ability and dexterity are typically reduced. Also, mirror movements (MMs), are often present in UCP, with a further possible negative functional impact. This study aims to investigate the relationships among neuroanatomical characteristics of brain injury at MRI, manual functional impairment and MMs, in children with UCP. Thirty-five children with UCP participated in the study (20, M = 15, F, mean age 9.2 ± 3.5 years). Brain lesions at MRI were categorized according to the Magnetic Resonance Classification System (MRICS) and by using a semi-quantitative MRI (sqMRI) scale. Gross manual performance was assessed through Manual Ability Classification System (MACS) and the Box and Block Test (BBT), and MMs by Woods and Teuber scale, for both hands. Non-parametric correlation analyses were run to determine the relationship between neuroanatomical and functional features. Regression models were run to explore the contribution of neuroanatomical features and MMs to UL function. Correlation analyses revealed moderate to strong associations between sqMRI scores contralateral to the more affected side and UL functional impairment on MACS and BBT, with more severe brain injuries significantly correlating with poorer function in the more affected hand. No association emerged between brain lesion severity scores and MMs. MRICS showed no association with MACS or BBT, while a significant correlation emerged between MRICS category and MMs in the more affected hand, with brain lesion category that are suggestive of presumed earlier injury being associated with more severe MMs. Finally, exploratory regression analyses showed that neuroanatomical characteristics of brain injury and MMs contributed to the variability of UL functional impairment. This study contributes to the understanding of the neuroanatomical and neurological correlates of some aspects of manual functional impairment in UCP by using a simple clinical brain MRI assessment.

Effectiveness of the home-based training program Tele-UPCAT (Tele-monitored UPper Limb Children Action Observation Training) in unilateral cerebral palsy: a randomized controlled trial.

BACKGROUND: The effects of unilateral cerebral palsy (UCP) are largely observed in the upper limb (UL), which represents the main focus of rehabilitation for this disorder. Thanks to an increment in home training and progress in technology innovative systems have been created. The Tele-UPCAT (Tele-monitored UPper Limb Children Action Observation Training) platform is dedicated to the delivery at home of a program for UL rehabilitation, based on action observation therapy (AOT). AIM: This study aimed to investigate the immediate effectiveness of Tele-UPCAT for promoting UL skills in children with UCP and to determine if immediate effects were retained in the medium and long term. DESIGN: Tele-UPCAT was conducted on an intention-to-treat basis and was proposed as a randomized, allocation concealed (waitlist controlled) and evaluator-blinded clinical trial with two investigative arms: intensive in-home AOT program and standard care (SC). SETTING: This is a home-based AOT program delivered with a customized ICT platform. POPULATION: Thirty children (mean age 11.61±3.55 years) with confirmed diagnosis of spastic UCP with predominant UL involvement and cognitive level within or at normal limits were enrolled in this study. Orthopedic surgery or an intramuscular botulinum toxin A injection in the UL within 6 months prior to enrolment represented an exclusion criteria. METHODS: Participants were randomized using concealed random allocation. They were assessed according to the study design with the Assisting Hand Assessment (AHA), the Box and Block Test (BBT) and the Melbourne Assessment 2 (MA2). Linear mixed models were used for statistical analysis. RESULTS: A significant difference between the AOT and SC groups was identified immediately after the training on the AHA (6.406 [2.73] P=0.021) with an effect size (ES) of 1.99, and for the BBT of the less affected hand (9.826 [4.535] P=0.032) with an ES of 1.44. These effects were sustained at medium and long term. CONCLUSIONS: This study supports the effectiveness of AOT home training in promoting UL skills in children with UCP, with immediate effects lasting for 6 months. CLINICAL REHABILITATION IMPACT: This should encourage the use of technology for rehabilitative purposes and further applications of the AOT paradigm.

Wearable accelerometers for measuring and monitoring the motor behaviour of infants with brain damage during CareToy-Revised training.

BACKGROUND: Nowadays, wearable sensors are widely used to quantify physical and motor activity during daily life, and they also represent innovative solutions for healthcare. In the clinical framework, the assessment of motor behaviour is entrusted to clinical scales, but they are dependent on operator experience. Thanks to their intrinsic objectivity, sensor data are extremely useful to provide support to clinicians. Moreover, wearable sensors are user-friendly and compliant to be used in an ecological environment (i.e., at home). This paper aims to propose an innovative approach useful to predict clinical assessment scores of infants' motor activity. MATERIALS AND METHODS: Starting from data acquired by accelerometers placed on infants' wrists and trunk during playtime, we exploit the method of functional data analysis to implement new models combining quantitative data and clinical scales. In particular, acceleration data, transformed into activity indexes and combined with baseline clinical data, represent the input dataset for functional linear models. CONCLUSIONS: Despite the small number of data samples available, results show correlation between clinical outcome and quantitative predictors, indicating that functional linear models could be able to predict the clinical evaluation. Future works will focus on a more refined and robust application of the proposed method, based on the acquisition of more data for validating the presented models. TRIAL REGISTRATION NUMBER: ClincalTrials.gov; NCT03211533. Registered: July, 7th 2017. ClincalTrials.gov; NCT03234959. Registered: August, 1st 2017.

Parental Practices and Environmental Differences among Infants Living in Upper-Middle and High-Income Countries: A Cross-Sectional Study.

Parental practices and environmental factors can impact a child's development and, consequently, functionality. The objective is to assess the parental practices and environmental differences in healthy and at-risk infants at 3-6 months of age living in upper-middle (Brazil) and high-income (Italy) countries. A total group of 115 infants was identified and classified into four groups: healthy Italian infants (H_IT); Italian infants exposed to biological risk factors (R_IT); healthy Brazilian infants (H_BR); and Brazilian infants exposed to environmental risk factors (L_BR). The dependent variables were parental practices and environmental factors, which were assessed through a semi-structured interview and the "variety of stimulation dimension" from the Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS) questionnaire. Descriptive analyses, a multivariate analysis of variance (MANOVA), and correlation tests were applied. Regarding the environment and parental practices, the mother's age, maternal and paternal education, civil status, and variety of stimulation showed significant differences among the infants living in Brazil or in Italy. There were strong dissimilarities in parental practices and environmental factors among infants living in low/upper-middle and high-income countries. Since the home environment is the main stimulus for infant growth and development, our results are meaningful for providing knowledge about these two different cultures.

New Technological Approach for the Evaluation of Postural Control Abilities in Children with Developmental Coordination Disorder.

Background: Developmental Coordination Disorder (DCD) causes difficulties in postural control which are crucial to assess due to their impact on everyday life. There is a lack of suitable tools to acquire quantitative data and deeply analyze postural control, especially during the developmental age. The aim of this study is to investigate postural control skills in children with DCD and typically developing children (TD) using the Virtual Reality Rehabilitation System (VRRS). Methods: 18 children with DCD and 30 TD children (mean age 9.12 ± 2.65 and 7.12 ± 2.77 years, respectively) were tested by using the Movement Assessment Battery for Children Second Edition (MABC-2) and a VRRS stabilometric balance platform. A t-test was performed to identify differences in the VRRS parameters between the two groups. Furthermore, we investigated whether a correlation exists between the VRRS data and the MABC-2. Results: Significant differences (p < 0.05) in mean distance and frequency of the COP are found in the two groups. These parameters also correlate with the MABC-2 total score (p ≤ 0.05) and balance subscales (p ≤ 0.05). Conclusions: This study opens a new frontier for the assessment of postural skills in children with DCD and represents a potential basis for a tailored rehabilitation program, from which their postural stability and, consequently, their everyday life will benefit.

Feasibility of audio-motor training with the multisensory device ABBI: Implementation in a child with hemiplegia and hemianopia.

Spatial representation is crucial when it comes to everyday interaction with the environment. Different factors influence spatial perception, such as body movements and vision. Accordingly, training strategies that exploit the plasticity of the human brain should be adopted early. In the current study we developed and tested a new training protocol based on the reinforcement of audio-motor associations. It supports spatial development in one hemiplegic child with an important visual field defect (hemianopia) in the same side of the hemiplegic limb. We focused on investigating whether a better representation of the space using the sound can also improve the involvement of the hemiplegic upper limb in daily life activity. The experimental training consists of intensive but entertaining rehabilitation for two weeks, during which a child performed ad-hoc developed audio-motor-spatial exercises with the Audio Bracelet for Blind Interaction (ABBI) for 2 h/day. We administered a battery of tests before and after the training that indicated that the child significantly improved in both the spatial aspects and the involvement of the hemiplegic limb in bimanual tasks. During the assessment, ActiGraph GT3X+ was used to measure asymmetry in the use of the two upper limbs with a standardized clinical tool, the Assisting Hand Assessment (AHA), pre and post-training. Additionally, the study measured and recorded spontaneous daily life activity for at least 2 h/day. These results confirm that one can enhance perceptual development in motor and visual disorders using naturally associated auditory feedback to body movements.

Application of Virtual Reality Rehabilitation System for the assessment of postural control while standing in typical children and peers with neurodevelopmental disorders.

BACKGROUND: The assessment of postural control in children is crucial, due to its central role in their overall development. However, a tool that objectively quantifies the difference in postural control between typical and atypical developing children is lacking. In this study, we introduce a new technology (Virtual Reality Rehabilitation System, VRRS) for assessing children's postural control. RESEARCH QUESTION: Is this new assessment tool capable to highlight the differences between typical development (TD) and atypical development, (children with Developmental Coordination Disorder (DCD) and Cerebral Palsy (CP))? METHODS: 30 TD children, 20 children with DCD and 27 with CP (mean ages: 6.29 ± 2.74; 9.11 ± 2.65; 10.07 ± 3.89 years) were tested with the VRRS Tablet with stabilometric balance platform. Postural parameters, related to the movements of the Centre of Pressure (COP) were collected. A multivariate analysis of variance (MANOVA) followed by a post-hoc analysis has been carried out. Moreover, the influence of age, sex, clinical scores and sub-diagnoses on parameters of interest has been explored. RESULTS: COP distance and sway area in the three groups (TD: 7.35 ± 2.32 mm, 101.70 ± 64.16 mm2/s; DCD: 12.05 ± 8.19 mm, 188.46 ± 231.23 mm2/s; CP: 13.25 ± 8.09 mm, 239.13 ± 313.83 mm2/s, respectively) and all other VRRS parameters were significantly different among the three groups (p-values between 0.028 and <0.001). The TD group showed significantly different values than CP (p from < 0.03 to < 0.001) but not than DCD (p = n.s.). Clinical scores showed to correlate with the COP distances and Root Mean Square distances in all subgroups (p < 0.05). For age, only an influence was found within the TD group (p < 0.01); sex did not show to affect the outcomes (p = n.s.). SIGNIFICANCE: An objective tool for quantitative measurement of postural control in childhood is needed. Our proposed VRRS tool could support the traditional assessment tests, highlighting differences between typical and atypical development.

Tele-Rehabilitation for Postural Control by Means of Virtual Reality Rehabilitation System in an Adolescent With Motor Disorder: A Case Study.

The coming of an unforeseen and hostile event such as the COVID-19 pandemic has brought about various changes in everyone's daily life. During the lockdown period, a huge number of restrictions were imposed, hence interrupting a wide range of activities previously proven to be necessary for some people. Due to the circumstances, rehabilitation treatments for children with neurodevelopmental disorders have been suspended, resulting in consequent distress for the children themselves and their parents. To overcome this problem, a tele-rehabilitation approach has proven to be an excellent solution to give continuity to children's rehabilitation. The tele-rehabilitation approach allows access to rehabilitation services directly from home. During lockdown due to the COVID-19 pandemic, the Virtual Reality Rehabilitation System (VRRS) HomeKit, developed by Khymeia, was employed as a rehabilitation system for the treatment of posture and balance of an adolescent with disabilities for the first time ever. Specifically, a 17-year-old female patient was enrolled and evaluated by the clinical staff before and after the home-training sessions. The system was delivered to the patient's home so that she could perform the tasks in a familiar environment, while under the supervision of the clinical staff. Through a specific platform, using different modules of the system, therapists could remotely check that the proposed exercises were properly performed and provide feedback and/or increase the difficulty according to the patient's needs and progress. Therefore, the treatment performed was carried out at home in a personalized, intensive, and playful way; characteristics do not present in a traditional treatment. Our results are promising and demonstrate both the efficacy of rehabilitation exercises carried out at home and the feasibility of home-based rehabilitation, when using the VRRS HomeKit even with adolescents. The VRRS HomeKit presents some limitations, such as the need to have the line connection and free space at home, the presence of technical issues, and the education of parents and patients to understand the instructions. Despite the limitations, this study provides the basis for continuing the experience of tele-rehabilitation on patients with a motor disorder also by customizing the exercises to their characteristics.

Feasibility of Early Intervention Through Home-Based and Parent-Delivered Infant Massage in Infants at High Risk for Cerebral Palsy.

Infant massage (IM) can be considered an early intervention program that leads to the environmental enrichment framework. The effectiveness of IM to promote neurodevelopment in preterm infants has been proved, but studies on infants with early brain damage are still lacking. The main aim of this study was to assess the feasibility, acceptability and usability of IM, carried out by parents at home, on infants at high risk for Cerebral Palsy. An IM daily diary and an ad hoc questionnaire, called Infant Massage Questionnaire Parent-Infant Experiences (IMQPE), were developed. IMQPE consisted of a total of 30 questions, divided into 5 areas. The parents were trained to carry out the IM with a home-based course, conducted by an expert therapist. The intensive IM program was set according to a defined daily length of at least 20 min, with a frequency of at least 5 days per week for a total of 8 weeks. Data collection consisted in the selection of the variables around the characteristics, both of the infants and the mothers, IM dosage and frequency, different body parts of the infants involved and IMQPE scores. Variable selection was carried out by minimizing the Bayesian Information Criteria (BIC) over all possible variable subsets. Nineteen high-risk infants, aged 4.83 ± 1.22 months, received IM at home for 8 weeks. The massage was given by the infants' mothers with a mean daily session dose of 27.79 ± 7.88 min and a total of 21.04 ± 8.49 h. 89.74% and 100% of mothers performed the IM for the minimum daily dosage and the frequency recommended, respectively. All the families filled in the IMQPE, with a Total mean score of 79.59% and of 82.22% in General Information on IM, 76.30% in Infant's intervention-related changes, 76.85% in IM Suitability, 79.07% in Infant's acceptance and 83.52% in Time required for the training. Different best predictors in mothers and in infants have been found. These data provide evidence of the feasibility of performing IM at home on infants at high risk for CP. Study registration: www.clinicaltrial.com (NCT03211533 and NCT03234959).

Concurrent and predictive validity of the infant motor profile in infants at risk of neurodevelopmental disorders.

BACKGROUND: Preterm infants and infants with perinatal brain injury show a 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 Scale (AIMS) and Prechtl's General Movement Assessment (GMA). The present study aims to evaluate the concurrent validity of the IMP with the AIMS, to assess its association with the GMA, to evaluate how the IMP reflects the severity of the brain injury and to compare the ability of the IMP and the AIMS to predict an abnormal outcome in 5-month-old 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 the GMA and at 5 months CA using the IMP and the AIMS. The neurodevelopmental outcome was established at 18 months. RESULTS: Results confirm a solid concurrent validity between the IMP Total Score and the AIMS (Spearman's ρ 0.76; p < .001) and a significant association between IMP Total Score and the GMA. Unlike the AIMS, the IMP Total score accurately reflects the severity of neonatal brain injury (p < .001) and proves to be the strongest predictor of NDD (p < .001). The comparison of areas under receiver operating characteristic curves (AUC) confirms that the IMP Total score has the highest diagnostic accuracy at 5 months (AUC 0.92). For an optimal IMP Total Score cut-off value of 70, the assessment shows high sensitivity (93%) and specificity (81%) (PPV 84%; NPV 90%). CONCLUSIONS: Early motor behaviour assessed with the IMP is strongly associated with middle-term neurodevelopmental outcome. The present study confirms the concurrent validity of the IMP with the AIMS, its association with the GMA and its ability to reflect brain lesion load, hence contributing to the construct validity of the assessment. TRIAL REGISTRATION: NCT01990183 and NCT03234959 (clinicaltrials.gov).

Feasibility of a Home-Based Action Observation Training for Children With Unilateral Cerebral Palsy: An Explorative Study.

Unilateral Cerebral Palsy (UCP), the most frequent form of Cerebral Palsy, usually affects more the upper limb (UL) than the lower limb. Rehabilitation programs are addressed to improve manual abilities and UL use. In recent years, Information and Communication Technology (ICT) has been introduced in rehabilitation to increase treatment opportunities for patients, and also in home-based intervention. Moreover, the discovery of the Mirror Neuron System allowed to insert a new paradigm of treatment that is the Action Observation Training (AOT). The aim of the present study was to investigate the feasibility of a new rehabilitative home-based approach, called Tele-UPCAT (Tele-monitored UPper Limb Children Action Observation Training), based on the principles of AOT, in a group of Italian children and adolescents with UCP. This investigation was to provide information about the possibility of introducing ICT in telerehabilitation field. Twenty-nine children aged 11.73 ± 3.65 years (range 6.00-18.75) with a diagnosis of UCP participated in the study. They carried out 15 days of training based on the AOT paradigm with Tele-UPCAT system while wearing Actigraphs on both wrists. The feasibility of both training and study design and procedures was assessed through nine criteria taken from existent literature and from a questionnaire designed and realized ad hoc for the purpose, based on standard items of usability and acceptability. All feasibility criteria were met: 80% of training sessions were completed in the planned time and no significant technical issues were found. From the questionnaire, total scores were all above 82.15%, while the four sections obtained the following scores: (i) customization of exercises 80.00%; (ii) acceptability at home, 77.50%; (iii) required effort 80.00%; and (iv) suitability of manual and software 95.00%. No differences were found for age and sex. Tele-UPCAT demonstrated to be feasible as a home-based AOT for children and adolescents with UCP. Trial registration NCT03094455.

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

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.

Action observation training for rehabilitation in brain injuries: a systematic review and meta-analysis.

BACKGROUND: To systematically review and analyse the effects of Action Observation Training on adults and children with brain damage. METHODS: Seven electronic databases (Cochrane, EBSCO, Embase, Eric, PubMed, Scopus and Web of Science) were searched up to 16 September 2018 to select Randomized Controlled Trials focused on adults and children with brain damage that included AOT training on upper and/or lower limb carried out for at least 1 week. Identification of studies and data extraction was conducted with two reviewers working independently. Oxford Centre for Evidence-based Medicine (March2009) - Levels of Evidence and Physiotherapy Evidence Database scale were used to grade studies. The data collected from the articles were analysed using software R, version 3.4.3. Hedge's g values were calculated and effect size estimates were pooled across studies. Separate meta-analyses were carried out for each ICF domain (i.e. body function and activity) for upper and lower limb. RESULTS: Out of the 210 records identified after removing duplicates, 22 were selected for systematic review and 19 were included in the meta-analysis. Thirteen studies included in the meta-analysis focused on upper limb rehabilitation (4 in children and 9 in adults) and 6 on lower limb rehabilitation (only studies in adults). A total of 626 patients were included in the meta-analysis. An overall statistically significant effect size was found for upper limb body function (0.44, 95% CI: [0.24, 0.64], p < 0.001) and upper limb activity domain (0.47, 95% CI: [0.30, 0.64], p < 0.001). For lower limb, only the activity domain was analysed, revealing a statistically significant overall effect size (0.56, 95% CI: [0.28, 0.84], p < 0.001). CONCLUSIONS: Action Observation Training (AOT) is an innovative rehabilitation tool for individuals with brain damage, which shows promising results in improving the activity domain for upper and lower limbs, and also the body function domain for the upper limb. However, the examined studies lack uniformity and further well-designed, larger controlled trials are necessary to determine the most suitable type of AOT particularly in children. SYSTEMATIC REVIEW REGISTRATION: CRD42019119600.

Effects on Parental Stress of Early Home-Based CareToy Intervention in Low-Risk Preterm Infants.

Parenting a preterm infant is more challenging than a full-term one. Parent involvement in early intervention programs seems to have positive psychosocial effects on both the child and parent. CareToy is an innovative smart system that provides an intensive individualized home-based family-centred EI in preterm infants between 3 and 9 age-corrected months. A RCT study, preceded by a pilot study, has been recently carried out to evaluate the effects of CareToy intervention on neurodevelopmental outcomes with respect to Standard Care. This study aims at evaluating the effects of CareToy early intervention on parenting stress in preterm infants. Parents (mother and father) of a subgroup of infants enrolled in the RCT filled out a self-report questionnaire on parenting stress (Parenting Stress Index-Short Form (PSI-SF)) before (T0) and after (T1) the CareToy or Standard Care period (4 weeks), according to the allocation of their preterm infant. For twins, an individual questionnaire for each one was filled out. Results obtained from mothers and fathers were separately analysed with nonparametric tests. 44 mothers and 44 fathers of 44 infants (24 CareToy/20 Standard Care) filled out the PSI-SF at T0 and at T1. CareToy intervention was mainly managed by mothers. A significant (p < 0.05) reduction in Parental Distress subscale in the CareToy group versus Standard Care was found in the mothers. No differences were found among the fathers. CareToy training seems to be effective in reducing parental distress in mothers, who spent more time on CareToy intervention. These findings confirm the importance of parental involvement in early intervention programs. This trial is registered with Clinical Trial.gov NCT01990183.

Actigraph assessment for measuring upper limb activity in unilateral cerebral palsy.

BACKGROUND: Detecting differences in upper limb use in children with unilateral cerebral palsy (UCP) is challenging and highly dependent on examiner experience. The recent introduction of technologies in the clinical environment, and in particular the use of wearable sensors, can provide quantitative measurement to overcome this issue. This study aims to evaluate ActiGraph GT3X+ as a tool for measuring asymmetry in the use of the two upper limbs (ULs) during the assessment with a standardized clinical tool, the Assisting Hand Assessment (AHA) in UCP patients aged 3-25 years compared to age-matched typically developing (TD) subjects. METHODS: Fifty children with UCP and 50 TD subjects were assessed with AHA while wearing ActiGraphs GT3X+ on both wrists. The mean activity of each hand (dominant and non-dominant, MADH and MANDH, respectively) and the asymmetry index (AI) were calculated. Two linear mixed model analyses were carried out to evaluate how dependent actigraphic variables (i.e. MANDH and AI) varied by group (TD vs UCP) and among levels of manual ability based on Manual Ability Classification System (MACS). In both models age, sex, side of hemiplegia, presence/absence of mirror movements were specified as random effects. RESULTS: The MANDH was significantly lower in UCP compared to TD, while the AI was significantly higher in UCP compared to TD. Moreover, in UCP group there were significant differences related to MACS levels, both for MANDH and AI. None of the random variables (i.e. age, sex, side, presence/absence of mirror movements) showed significant interaction with MANDH and AI. CONCLUSIONS: These results confirm that actigraphy could provide, in a standardized setting, a quantitative description of differences between upper limbs activity. TRIAL REGISTRATION: ClincalTrials.gov, NCT03054441 . Registered 15 February 2017.

Assessment of upper limb use in children with typical development and neurodevelopmental disorders by inertial sensors: a systematic review.

Understanding development of bimanual upper limb (UL) activities in both typical and atypical conditions in children is important for: i) tailoring rehabilitation programs, ii) monitoring progress, iii) determining outcomes and iv) evaluating effectiveness of treatment/rehabilitation. Recent technological advances, such as wearable sensors, offer possibilities to perform standard medical monitoring. Body-worn motion sensors, mainly accelerometers, have shown very promising results but, so far, these studies have mainly focused on adults. The main aim of this review was to report the evidence of UL activity of both typically developing (TD) children and children with neurodevelopmental disorders (NDDs) that are reliably reported and comparable, using a combination of multiple wearable inertial sensors, both in laboratory and natural settings. Articles were selected from three research databases (PubMed, Web of Science and EBSCO). Included studies reported data on children aged 0-20 years old simultaneously wearing at least two inertial sensors on upper extremities. The collected and reported data were relevant in order to describe the amount of physical activity performed by the two ULs separately. A total of 21 articles were selected: 11 including TD, and 10 regarding NDDs. For each article, a review of both clinical and technical data was performed. We considered inertial sensors used for following aims: (i) to establish activity intensity cut-points; (ii) to investigate validity and reliability of specified markers, placement and/or number of inertial sensors; (iii) to evaluate duration and intensity of natural UL movements, defined motor tasks and tremor; and (iv) to assess efficacy of certain rehabilitation protocols. Our conclusions were that inertial sensors are able to detect differences in use between both hands and that all reviewed studies support use of accelerometers as an objective outcome measure, appropriate in assessing UL activity in young children with NDDs and determining intervention effectiveness. Further research on responsiveness to interventions and consistency with use in real-world settings is needed. This information could be useful in planning UL rehabilitation strategies.

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

BACKGROUND: Congenital 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/DESIGN: This 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. DISCUSSION: This 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 REGISTRATION: NCT03211533 and NCT03234959 ( www.clinicaltrials.gov ).

Tele-UPCAT: study protocol of a randomised controlled trial of a home-based Tele-monitored UPper limb Children Action observation Training for participants with unilateral cerebral palsy.

INTRODUCTION: A new rehabilitative approach, called UPper Limb Children Action Observation Training (UPCAT), based on the principles of action observation training (AOT), has provided promising results for upper limb rehabilitation in children with unilateral cerebral palsy (UCP). This study will investigate if a new information and communication technology platform, named Tele-UPCAT, is able to deliver AOT in a home setting and will test its efficacy on children and young people with UCP. METHODS AND ANALYSIS: A randomised, allocation concealed (waitlist control) and evaluator-blinded clinical trial with two investigative arms will be carried out. The experimental group will perform AOT at home for 3 weeks using a customised Tele-UPCAT system where they will watch video sequences of goal-directed actions and then complete the motor training of the same actions. The control group will receive usual care for 3 weeks, which may include upper limb training. They will be offered AOT at home after 3 weeks. Twenty-four children with UCP will be recruited for 12 participants per group. The primary outcome will be measured using Assisting Hand Assessment. The Melbourne Assessment 2, ABILHAND, Participation and Environment Measure-Children and Youth and Cerebral Palsy Quality of Life Questionnaire will be included as secondary measures. Quantitative measures from sensorised objects and participants worn Actigraphs GXT3+ will be analysed. The assessment points will be the week before (T0) and after (T1) the period of AOT/standard care. Further assessments will be at T1 plus, the week after the AOT period for the waitlist group and at 8 weeks (T2) and 24 weeks (T3) after AOT training. ETHICS AND DISSEMINATION: The trial has been approved by the Tuscany Paediatric Ethics Committee (169/2016). Publication of all outcomes will be in peer-reviewed journals and conference presentations. TRIAL REGISTRATION: NCT03094455.

Potentials of Ultrahigh-Field MRI for the Study of Somatosensory Reorganization in Congenital Hemiplegia.

Reorganization of somatosensory function influences the clinical recovery of subjects with congenital unilateral brain lesions. Ultrahigh-field (UHF) functional MRI (fMRI) with the use of a 7 T magnet has the potential to contribute fundamentally to the current knowledge of such plasticity mechanisms. The purpose of this study was to obtain preliminary information on the possible advantages of the study of somatosensory reorganization at UHF fMRI. We enrolled 6 young adults (mean age 25 ± 6 years) with congenital unilateral brain lesions (4 in the left hemisphere and 2 in the right hemisphere; 4 with perilesional motor reorganization and 2 with contralesional motor reorganization) and 7 healthy age-matched controls. Nondominant hand sensory assessment included stereognosis and 2-point discrimination. Task-dependent fMRI was performed to elicit a somatosensory activation by using a safe and quantitative device developed ad hoc to deliver a reproducible gentle tactile stimulus to the distal phalanx of thumb and index fingers. Group analysis was performed in the control group. Individual analyses in the native space were performed with data of hemiplegic subjects. The gentle tactile stimulus showed great accuracy in determining somatosensory cortex activation. Single-subject gentle tactile stimulus showed an S1 activation in the postcentral gyrus and an S2 activation in the inferior parietal insular cortex. A correlation emerged between an index of S1 reorganization (distance between expected and reorganized S1) and sensory deficit (p < 0.05) in subjects with hemiplegia, with higher distance related to a more severe sensory deficit. Increase in spatial resolution at 7 T allows a better localization of reorganized tactile function validated by its correlation with clinical measures. Our results support the S1 early-determination hypothesis and support the central role of topography of reorganized S1 compared to a less relevant S1-M1 integration.