Cerebral Palsy

This research aims to study the immediate effects of using Dynamic Ankle-Foot Orthoses (DAFOs) on balance and gross motor functions in children with spastic diplegic cerebral palsy aged 4 to 15 years who have mild to moderate motor impairment (GMFCS levels 1 and 2). Diplegic cerebral palsy mainly affects the lower limbs, causing movement difficulties and abnormal gait patterns. The study plans to contribute valuable knowledge to cerebral palsy rehabilitation by evaluating motor skills and balance with and without DAFO use. Children participating in the study will be assessed using various classification systems for motor, communication, manual, and eating abilities. Their gross motor functions and balance will be measured using tests such as the Gross Motor Function Measure (GMFM-88), Pediatric Berg Balance Scale, functional reach test, and Wii Balance Board. The evaluations will occur both while wearing custom-made DAFOs and barefoot, comparing the immediate impact of the orthoses. Participants will have their age, height, and weight recorded along with assessments like the GMFCS, MACS, CFCS, and EDACS. The study uses standardized balance and motor function tests on day 1 to measure outcomes. Data analysis will be performed by a blinded statistician using appropriate statistical methods. The study is observational and will include children and their families who agree to participate at a specialized rehabilitation center, with all assessments completed during the study period.

Researchers are conducting the 100-Year Human Aging Study, an observational trial designed to follow participants over their lifespans to investigate which health measurements can predict mortality, serious diseases, and functional disability. The study aims to validate many longevity measures that currently lack prospective evidence by tracking physiological, cognitive, social, and environmental factors that change with aging. This research will generate important data to improve understanding of aging and longevity medicine. Participants undergo comprehensive multi-system clinical screenings including tests like cardiopulmonary exercise testing, body composition assessment by DEXA, echocardiography, electrocardiography, spirometry, neurocognitive testing, sensory assessments, metabolic testing, and detailed medical and social histories. The study allows for different levels of participation, from single tests to full two-visit screening batteries, and encourages repeat testing to capture health changes over time. During the study, participants receive individualized reports including investigational estimates of biological age and predicted cause of death. Researchers collect data on mortality, serious health events, chronic diseases, functional ability, and lifestyle changes through periodic follow-up over many years, potentially up to 100 years. This extensive data collection helps evaluate how well these measurements predict aging outcomes. All data are stored in raw form for future analysis and participants are supported with ongoing contact and opportunities for repeat assessments.

Preterm birth, defined as birth before 37 weeks of gestation, occurs in about 8 percent of pregnancies in Canada and is linked to many health challenges, especially when it happens before 29 weeks. At this early stage, infants often face breathing difficulties and may require resuscitation. This trial compares resuscitation using either low (30%) or high (60%) oxygen levels to determine which approach results in better survival and neurodevelopmental outcomes at around 24 months of age. The study uses a cluster randomized crossover design where hospitals alternate between starting resuscitation with 30% or 60% oxygen for groups of 30 infants. Resuscitation includes standard care steps like lung expansion and ventilation support as needed. Oxygen is initially given at the assigned concentration for the first 5 minutes, then adjusted based on the infant's oxygen saturation levels and heart rate over the next 5 minutes to maintain target saturation ranges. This approach aims to balance risks of too much or too little oxygen. Participants are infants born between 23 and 28 weeks gestation who receive full resuscitation at participating centers. During the study, infants have oxygen saturation monitored continuously, and adjustments to oxygen concentration are made carefully. Researchers will evaluate survival and major neurodevelopmental outcomes at 24 months corrected age, along with several safety and health measures during the neonatal intensive care stay. The trial is expected to provide important evidence to guide oxygen use during resuscitation of extremely preterm infants.

Researchers are investigating how muscle development and growth are altered at the microscopic level over time in children with cerebral palsy (CP). This study focuses on understanding the microscopic muscle properties in young children with CP and how these relate to larger muscle features, neuromuscular symptoms, and treatments like botulinum toxin (BTX) injections. The goal is to identify different CP muscle types and improve personalized treatment strategies. The study collects muscle biopsies using a minimally invasive needle technique, sometimes under general anesthesia during routine treatments like BTX injections or orthopedic procedures. Biopsies will be taken from children with CP at varying ages and treatment stages and from typically developing children during surgeries. The research includes analyzing muscle fiber size, satellite cells, collagen content, and genetic factors. One part of the study follows changes before and after BTX treatment over up to 1.2 years. Participants will undergo ultrasound muscle imaging, clinical assessments of spasticity and strength, and gait analysis. Muscle biopsies are collected at multiple time points for detailed microscopic examination. Researchers will measure changes in muscle fiber characteristics, muscle volume and length, and muscle activation patterns. Data will be used to define integrated muscle and symptom profiles and how they respond to treatments over the study period, which may last up to 1.2 years for some participants.

Researchers are studying the brain's 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.

Researchers are evaluating the effectiveness and safety of Recombinant Botulinum Toxin Type A (YY001) injections for treating upper limb spasticity in adults who have had a stroke. This randomized, double-blind, multi-center phase II/III study compares YY001 with BOTOX4 and a placebo to better understand treatment options for this condition. Participants will receive a single intramuscular injection of either Recombinant Botulinum Toxin Type A (YY001) with a dose of 200-400 units, BOTOX4 with a dose of 200 units, or a placebo prepared with saline. The study includes three groups: the experimental group receiving YY001, an active-controlled group receiving BOTOX4, and a placebo-controlled group. Each participant receives only one injection during the treatment period. During the study, participants will be monitored at 1, 4, 8, and 12 weeks after treatment through assessments such as the Modified Ashworth Scale (MAS) for spasticity, Physician's Global Assessment, and Disability Assessment Scale (DAS). Researchers will also track any adverse events and the presence of antibodies to the treatment. The primary outcome is the change in MAS score at week 4. The study lasts at least 12 weeks with ongoing safety and efficacy follow-up.

Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this period.

Adults with cerebral palsy (CP) often face difficulties in accessing exercise programs tailored to their needs due to limited mobility, lack of suitable options, and restricted physiotherapy access. Regular exercise is important for improving physical health, mental well-being, and overall quality of life, but many adults with CP do not have structured opportunities for physical activity. This research aims to evaluate the feasibility of delivering an accessible online exercise program designed specifically for adults with CP, focusing on demand, practicality, acceptability, and potential benefits to physical, mental, and social health. The study will recruit 60 adults with CP who will be randomly assigned to one of two groups. One group will participate in an 8-week online exercise and education program that includes weekly online exercise classes targeting strength, balance, and range of movement, along with educational materials covering topics like exercise, nutrition, fatigue, bone health, pain management, mental health, and sleep. The other group will receive the same educational materials over 8 weeks without the exercise classes and will be informed about the home exercise program after the intervention period. Participants will be monitored throughout the study with data collected on attendance, completion rates, engagement with exercises, and any adverse events. Health-related surveys will be completed before and after the program to assess changes in physical function, mobility, pain, fatigue, sleep, self-efficacy, depression, and participation. Selected participants will also provide feedback through interviews. The study duration includes rolling recruitment over 1.2 years and outcome measurements over 2 years, aiming to support the development of effective online exercise programs for adults with CP.

Researchers are studying brain activation patterns in stroke patients during mirror movement to understand upper limb function. This observational study focuses on patients who have had their first stroke, either cerebral infarction or cerebral hemorrhage, with specific muscle strength and muscle tone conditions. The study takes place in a hospital rehabilitation ward where patients receive detailed information and provide informed consent before participation. The study involves two types of hand movements: mirror image and healthy hand movement. In the mirror image intervention, patients place their affected hand in a mirror box and observe the reflection of the healthy hand moving, imagining the affected hand performing the same actions. In the healthy hand movement intervention, patients quickly open and grasp their healthy hand while focusing on the affected hand. The primary outcome is brain activation measured by functional near-infrared spectroscopy (fNIRS) after one week of hand function rehabilitation training. Participants will be closely monitored throughout the trial with full communication and support from the research team. The study involves observing brain activation and hand movement activity with attention to patients' questions and responses. The total participation period includes the initial week of rehabilitation training followed by assessments to measure the brain's response to the interventions.

Researchers are evaluating a new therapy approach called MOBILE to improve walking ability in children and teens with Cerebral Palsy. This study aims to find out if the therapy is acceptable and helpful to both the children and their families when provided in a community setting. The key questions include whether participants tolerate the therapy, if families find it manageable, and if children complete all therapy sessions and assessments as planned over the course of the study. The therapy uses motor learning principles to target each child's specific walking goal. Participants will complete a total of 30 hours of therapy over 6 weeks, with at least 24 hours conducted in a clinic. The remaining hours can be done through a home program. This flexible format allows children to choose how they complete their therapy sessions while focusing on improving their walking patterns. During the study, children will be assessed before and after therapy to see if they meet their walking goals. Researchers will also interview participants about their experience with the therapy. Various outcome measures will be tracked over 2 years, including recruitment, adherence, retention, adverse events, fidelity to the intervention, and the acceptability of the therapy. Functional walking tests and quality of life assessments will be done at baseline, post-intervention, and at a 3-month follow-up. Participants are involved in therapy sessions, assessments, and interviews throughout the study period.