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Found 29 Actively Recruiting clinical trials
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Researchers are studying children and adolescents with neuromotor impairments to improve cognitive functions often affected in this group. The study focuses on enhancing skills like visual-perceptual analysis, selective attention, working memory, narrative organization, logical reasoning, and motor planning. It also aims to assess childrens behavioral, cognitive, and emotional engagement while interacting with a social robot, and to see if improvements generalize to related cognitive processes such as inhibition and planning. The study involves using a social robot in a unique Learning by Teaching approach, where children help the robot reorder sequences of pictures from figurative stories or actions. The training occurs twice a week for about four months, with tasks increasing in complexity and support provided to encourage learning without mistakes. Eighty children will be randomly assigned to either start the training immediately Experimental Group or continue their usual care and begin training after four months Control Group. Participants will undergo initial assessments of neuropsychological, motor, and school learning skills before starting. Engagement during sessions will be measured using sensors, eye-tracking, and video recordings. Follow-up assessments will occur at the end of the training and four months later to evaluate changes in cognitive and motor planning skills. The study will last about 16 months for each child, including training and observation periods.
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Researchers are investigating the changes in gene activity related to metabolic disorders in children and adolescents with neurodevelopmental disorders and irritability who are treated with antipsychotic drugs. The study aims to compare gene expression patterns in three groups those using antipsychotics with metabolic disorders, those using antipsychotics without metabolic disorders, and those with metabolic disorders not using antipsychotics. The goal is to identify early genetic markers that might predict the development of metabolic problems linked to antipsychotic treatment, which could help personalize therapy and reduce metabolic risks. Participants are divided into three groups based on their antipsychotic use and metabolic health status. The study involves a transcriptomic investigation, which examines gene activity from blood samples, followed by classification of these gene patterns. This observational study does not involve experimental treatment but focuses on understanding the biological changes associated with antipsychotic use and metabolic conditions. During the study, each participant will have their body mass index adjusted for age, sex, and height BMI-Z measured once at recruitment. Researchers will analyze gene expression in peripheral blood mononuclear cells to identify differences among the groups. The trial is led by IRCCS Eugenio Medea and includes children and adolescents aged 5 to 17 years. The study will continue until May 2026, with assessments focusing on metabolic and genetic markers relevant to antipsychotic treatment outcomes.
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Researchers are evaluating how pharmacological and psychotherapeutic group treatments affect clinical symptoms in children and adolescents diagnosed with ADHD, emotional-behavioral dysregulation, and externalizing disorders. This observational study aims to determine the effectiveness of these treatments on symptoms and explore associations between individual characteristics and treatment responses using behavioral, neuropsychological, and neurophysiological data. The study seeks to develop more personalized interventions based on these findings. Participants will receive either pharmacological treatment with methylphenidate or group psychological therapy. The drug treatment involves a test dose followed by a varying daily dose 5-20 mg adjusted by a child neuropsychiatrist. The group psychological treatment includes 16 weekly sessions lasting 1.5 hours each over four months, divided into age-based groups. A control group of patients on a waiting list will undergo the same assessments but will not receive treatment. Participants will undergo assessments before treatment and at multiple follow-ups at treatment start, end of treatment or drug titration phase 2-3 months, and six months post-treatment. Assessments include clinical and socio-demographic questionnaires, computerized neuropsychological tests, and neurophysiological recordings using near-infrared spectroscopy, EEG during attention tasks, and data from a smartwatch. Researchers will analyze clinical symptoms, emotion regulation, neuropsychological performance, and neurophysiological measures to assess changes and predict treatment outcomes.
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Spatial navigation skills are crucial for daily activities and overall quality of life, yet they are not commonly included in standard assessments or rehabilitation for patients. This research focuses on comparing spatial navigation abilities between typically developing children and children with cerebral palsy, who are known to have difficulties with visuo-spatial skills. The study uses an accessible approach by employing the StarMaze application through a Head Mounted Display HMD to evaluate these abilities. Participants undergo a baseline assessment that includes cognitive tests and pen-and-paper visuo-spatial evaluations. Then, they use the StarMaze virtual reality application via the Oculus Quest headset, which involves navigating a 5-way star-maze to find a hidden treasure. This setup measures both how participants learn spatial information and their navigation strategies, such as egocentric or allocentric approaches. After the session, participants complete questionnaires about cyber-sickness, usability, and their experience with the technology. Throughout the study, researchers assess navigation strategies as the primary outcome. Secondary evaluations include learning rates, simulator sickness, system usability, sense of presence, suitability of the technology, and mood scales. The study involves only one session of testing per participant, focusing on user experience and navigation performance. This approach aims to open new possibilities by using affordable virtual reality technology to assess and potentially train spatial skills in children.
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Healthy Volunteer
Researchers are studying sensorimotor skills as potential biomarkers that connect biological aspects of autism with behavioral and clinical features. This study focuses on early motor and sensory differences often seen in people with autism and their family members. It aims to understand how these skills develop, whether family relationships influence them, and how these differences may reveal biological mechanisms of autism. The study includes three main parts a longitudinal study of infant siblings at risk, a cross-sectional study comparing autistic children and their parents with typical families, and detailed phenotyping within individuals across behavioral, neural, and molecular levels. All children and their parents participating will undergo intellectual assessments and motor skill evaluations using tools like the Movement Assessment Battery for Children - Third Edition MABC-3, along with questionnaires completed by parents or participants. Motor profiles will also be analyzed through detailed movement tracking during specific upper-limb tasks. Additional evaluations include clinical assessments using autism-specific tools, neuropsychological tests, neurophysiological imaging, and genetic testing through blood or saliva samples. These assessments cover the studys experimental arm and support a comprehensive understanding of sensorimotor pathways in autism. Participants will be assessed immediately after the interventions using primary outcome measures such as the Movement Assessment Battery for Children 3, the Developmental Coordination Disorder Questionnaire, the Adult Developmental Coordination DisorderDyspraxia Checklist, and kinematic analysis of motor tasks. Secondary outcomes include MRI scans, spectroscopy, and exome sequencing. The study involves children aged 2 to 12 years, their parents, and infants under 24 months with a family history of autism. The research team will monitor participants intellectual and motor abilities, behavioral and neural traits, and genetic data to explore sensorimotor features linked to autism. The study is expected to continue until December 2026.
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Home Use of Agilik Powered Orthosis to Improve Walking and Endurance in Children with Cerebral Palsy
This research aims to evaluate whether using the Agilik powered orthosis for two months can improve knee extension and endurance in children with Cerebral Palsy who have a crouch gait. It also seeks to understand the safety of the Agilik device. The study compares children using the Agilik powered exoskeleton at home with those receiving standard therapy to see if the device helps with walking ability. Participants in the intervention group will use the Agilik orthosis at home for two months, practicing walking with the device for 30 minutes a day, five days a week. The control group will undergo standard therapy. The study includes visits to a clinic at the start, after three months, and again one month later to assess progress and safety. During the study, researchers will measure endurance and knee extension during walking at the beginning, after three months, and after four months. They will also assess joint range of motion, muscle length, spasticity, walking speed, posture, motor abilities, gait pattern, self-perceived performance in daily life, and balance. For those using the Agilik device, usability, acceptability, and behavioral engagement will be evaluated after treatment. Participants are monitored over several months with clinic visits to understand outcomes and safety.
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Researchers are investigating the brain mechanisms involved in spatial navigation skills in children and adolescents aged 8 to 17 years. These skills help individuals find their way, locate objects, and remember their positions in both familiar and new environments. The study focuses on comparing typically developing children with those affected by cerebral palsy CP to better understand differences in navigation abilities and how they relate to the condition. Participants will complete a navigation task within an immersive virtual reality environment while their brain activity is recorded using an electroencephalogram EEG. They will wear virtual reality viewers and an EEG cap as they navigate a five-way maze to find a treasure across 30 attempts, each lasting up to two minutes. Before this, their cognitive and spatial navigation skills will be assessed using tests like the Raven test, Corsi test, and the maze sub-test of the WISC-III. During the study, researchers will evaluate brain signal patterns and navigation performance from the single session of EEG recording and task completion. The study will measure power spectral density and navigation success to understand neural activity linked to navigation skills. This research aims to improve knowledge about spatial navigation in childhood and CP, potentially guiding future rehabilitation approaches. Participation includes one visit with assessments and virtual reality testing.
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Healthy Volunteer
Researchers are exploring early brain mechanisms that help infants process spoken language, focusing on how the brain tracks speech sounds. This observational study aims to understand differences in these neural processes between infants with and without a family history of language and learning challenges. The goal is to see if early brain responses can predict later language development in both typical and atypical cases. The study involves two groups of infants around 7 to 8 months old those with a family history of language disorders and those without. Participants will undergo non-invasive EEG recordings while listening to speech and musical sounds to assess brain activity related to auditory processing. They will also have a behavioral assessment using standardized developmental scales at 8 months. Follow-up assessments will take place about 10 months later, around 18 months of age, to measure language understanding and speaking skills. Researchers will collect background information like family history and socio-demographic factors. The study uses safe, non-invasive methods and does not require active responses from the infants, tracking their development over time to better understand early language acquisition.
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This research aims to investigate the effectiveness of play-based rehabilitation as usual care for children with cerebral palsy, a condition that affects movement and posture development and often involves other challenges like epilepsy and cognitive impairments. The study will also compare two rehabilitation formats intensive care provided in hospital inpatient units and extensive care delivered in community rehabilitation centers, to see if the timing of treatment affects outcomes. Children will receive either an extensive rehabilitation program consisting of 3-hour weekly sessions for 15 weeks in outpatient settings or an intensive program with 3-hour daily sessions, 5 days a week for 3 weeks in hospital care units. Both treatments include the same total dose of therapy and focus on goals involving gross motor skills, manipulative abilities, visual, and visual-cognitive functions. Participants will be assessed at the start, immediately after treatment, and at an 8-month follow-up using measures such as the Functional Independence Measure for children WeeFIM, the Gross Motor Function Measure 88 GMFM-88, and the Behavior Rating Inventory of Executive Function for preschool children. The study involves regular monitoring to evaluate the rehabilitation impact over time and to adjust care plans as needed, with total participation lasting through the follow-up period.
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Researchers are evaluating computerized Dynamic Assessment DA tests designed to identify the risk of Developmental Language Disorders DLD and Specific Reading Disorder SRD in children aged 4 to 9 years. These tests focus on measuring the learning potential of language and spelling abilities rather than just the absolute performance level. The study targets both monolingual and multilingual children attending preschool and primary school and aims to complete the validation of DA tests implemented on the MuLiMi digital platform, developed during the MultiMind project. The study includes several groups of children, categorized by language background and presence or absence of language or reading difficulties. Participants will be tested with the MuLiMi battery, which includes lexical, phonological, morphosyntactic, reading, orthographic, and metaphonological tests along with two Dynamic Assessment screening tests the Novel Word Learning Test NWLT for preschoolers and the Dynamic Reading Assessment DRA for school-age children. Tests are administered individually via the MuLiMi platform and involve learning new names or readingwriting codes presented in game form, with repeated practice until reaching a performance threshold. Participants will complete the assessment over one or two consecutive sessions depending on their age and cooperation. Researchers will measure accuracy and efficiency during task performance to evaluate learning capacity. Standardized language and reading tests will also be administered for validation purposes. The study offers baseline data for applying the MuLiMi battery broadly to children from various language backgrounds to assess risk for language and learning disorders, with participation expected to be completed within a few days.
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