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Found 8 Actively Recruiting clinical trials
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Researchers are studying the brains action observation network AON, which is involved in understanding and imitating movements, especially focusing on subcortical areas and the cerebellum. The study aims to explore how this network functions in healthy individuals and in people with Cerebral Palsy CP who have early brain injuries. This research seeks to understand differences in brain activation patterns and their relation to clinical features in CP patients using advanced imaging techniques. Participants will undergo a 7 Tesla MRI scan using a high-resolution functional and anatomical protocol. The MRI will capture detailed images of brain structures including the cerebral cortex, subcortical nuclei, and cerebellum. Visual tasks involving observation of hand movements and tool use will be presented during the scan. CP patients will also receive a full clinical assessment before the MRI. The study includes both healthy volunteers and CP patients, with careful monitoring of participant compliance to avoid motion artifacts. During the study, researchers will evaluate brain activation and connectivity maps of the AON from the 7T MRI data. Participants motor functions and clinical characteristics will be assessed for correlation with imaging results. The study involves observation during MRI scanning, clinical assessments, and monitoring of participants responses to visual stimuli. This trial is expected to provide detailed insights into brain network organization and its changes in CP. The total participation includes MRI scanning and clinical evaluations around a single visit.
Actively Recruiting
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.
Actively Recruiting
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.
Actively Recruiting
Healthy Volunteer
Researchers are exploring the Mirror Neuron System MNS and its role in rehabilitation techniques such as Action Observation Treatment AOT and Motor Imagery MI, which activate neural circuits during movement observation or imagination. This pilot observational study focuses on children and adolescents with Cerebral Palsy CP, the most common childhood motor disorder, and compares them with typically developing peers. The study aims to determine if a multisensory immersive AO session, combining visual, auditory, and tactile stimuli, produces stronger MNS activation than traditional visual-only AO sessions. Each participant will undergo two high-density Electroencephalography hdEEG sessions one immersive session featuring first-person videos with matching auditory cues and tactile stimuli delivered by haptic gloves, and a traditional session showing videos without sound or touch. The order of these sessions will be randomized. During both sessions, participants will observe actions, then perform or imagine them, while eye tracking monitors their gaze and attention. Throughout each session, brain activity will be recorded with a 128-channel hdEEG net, and videos will capture motor responses and compliance. After each session, participants will complete motor imagery questionnaires and tasks assessing their ability to imagine actions. Data analysis will compare neurophysiological responses between immersive and traditional AO, and explore relationships between brain activity, attention, motor imagery, and clinical assessments for the CP group. Participation involves two one-hour sessions with detailed monitoring and questionnaire assessments.
Actively Recruiting
Researchers are evaluating the effectiveness of a multi-domain robotic and technological rehabilitation program for children with neuromotor impairments. The study aims to determine if this holistic approach improves everyday life activities, motivation, active participation, and satisfaction compared to standard care involving single-domain rehabilitation with one innovative device. This trial involves children aged 5 to 21 years with confirmed developmental disorders or disabilities. Participants are randomly assigned to one of two treatment groups. One group receives a multi-domain rehabilitation treatment combining two or more innovative technological or robotic devices alongside conventional multidomain therapy. The other group receives a single-domain treatment using only one innovative device combined with conventional therapy. Treatment sessions consist of at least 20 sessions of 2 hours each, organized over two periods 4 weeks with 5 sessions per week and 7 weeks with 3 sessions per week. Throughout the study, participants will be evaluated three times using clinical outcome measures including the Canadian Occupational Performance Measure COPM at baseline, up to 7 weeks, and 2 months after training ends. Additional assessments cover motor function, attention, gait analysis, and questionnaires. Data will be pseudonymized and securely stored. Adherence to treatment will be monitored by clinical reviewers, with diaries maintained for each patient. The study will assess functional improvements, motivation, and quality of life changes over time with safety and data privacy measures in place.
Actively Recruiting
Cerebral Palsy CP is a leading cause of childhood disability marked by motor development challenges along with sensory, communication, cognitive, and emotional difficulties. This study aims to create a national digital platform across clinical centers in Italy to collect standardized, retrospective, and prospective clinical, instrumental, and genetic data on children and adolescents with CP. The goal is to analyze the prevalence of different CP types and assess the severity of functional impairments and related comorbidities in a large pediatric population. The study is observational and involves no treatment interventions. It includes systematic data collection through a hospital-based registry using a checklist completed for each participant. Data will include clinical evaluations, neuroradiological and electrophysiological information, and classifications of CP using multiple functional and communication scales. Enrollment targets a minimum of 300 participants aged 4 to 18 years across three centers, with ongoing monitoring of enrollment and data completeness every three months. Participants will be involved in routine clinical visits without additional procedures. Data collected include demographic information, CP classification, disorder etiology, and various functional levels such as motor, manual ability, communication, speech, and eatingdrinking abilities. Researchers will track study progress and adherence over 36 months. No medical devices or biological samples are used, and the study complements other national CP projects to improve knowledge and care standards.
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Researchers are evaluating a new portable robotic system called PhiCube for upper limb rehabilitation in children aged 4 to 18 years with congenital and acquired neuromotor disorders, as well as those with Developmental Coordination Disorder DCD. The study aims to explore the feasibility and effectiveness of this device in improving upper limb function and movement planning in these populations. The primary focus is on assessing movement quality using standardized tests. The treatment involves 30 sessions over approximately 3 months, with three 45-minute sessions each week. PhiCube is a modular robotic device designed for bilateral upper limb rehabilitation. It assists or resists movements through two motorized axes and combines motor training with gaming elements tailored for pediatric patients. The devices design allows customization to individual needs and targets range of motion, accuracy, dexterity, and fluency in movement. Participants will undergo assessments before treatment two time points and after treatment immediately and one month later using measures such as the Melbourne Assessment-2 for movement quality and the Abilhand-Kids questionnaire for daily activities. Additional neuropsychological tests and questionnaires will evaluate attention, inhibition, motor sequences, and auditory feedback perception. Researchers will analyze clinical and technological data to compare the devices rehabilitative effects across different diagnostic groups. Total participation spans the treatment period plus follow-up assessments.
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Electrocardiogram ECG Q-T prolongation is a heart rhythm disorder that can lead to serious arrhythmias. This observational study focuses on children and adolescents starting psychotropic medications that may increase the risk of QT prolongation. Researchers aim to understand how often QTc prolongation occurs as a side effect during long-term treatment with these drugs. Participants will have ECG tests recorded at the start of psychotropic therapy and again after 3, 6, and 12 months to monitor changes in the QT interval. The study includes groups of patients taking one psychotropic drug, those switching from one drug to another, and those on multiple drugs affecting the QT interval. This setup helps evaluate how different medication regimens might impact heart rhythm. During the study, participants will undergo regular ECG assessments and monitoring for any cardiac events at baseline and multiple time points up to 18 months after enrollment. Researchers will analyze these data to track changes in the QT interval and document any heart-related complications. The study is sponsored by Meyer Childrens Hospital IRCCS and will follow participants until January 2027.