Spasticity

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.

The 100-Year Human Aging Study is a long-term observational research project enrolling adult participants to undergo detailed multi-system health screenings and follow them throughout their lives until death. The study aims to identify which health measurements taken at enrollment and repeatedly over time can predict overall mortality, cause-specific death, serious diseases, and functional disability. It addresses the current lack of validated longevity measures by generating data on how various physiological and cognitive functions relate to aging outcomes. Participants undergo a comprehensive clinical screening that includes tests of cardiorespiratory fitness, strength, mobility, neurocognitive performance, sensory functions, and metabolic health. Structural imaging assessments like DEXA scans, echocardiography, electrocardiography, spirometry, retinal photography, and vascular ultrasound are performed. Laboratory tests and detailed medical, social, and environmental histories are also collected. The study allows participation from single tests up to a full two-visit screening, with repeat testing encouraged to track health changes over time. Throughout the study, participants receive individualized reports with investigational estimates of biological age and predicted mortality risks, which are being evaluated against actual health outcomes. Researchers collect data continuously on mortality, disease occurrence, disability, and health behavior changes. The study involves ongoing follow-up with periodic assessments and aims to preserve all collected data for future analyses, with participant involvement potentially spanning their entire lifespan.

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 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.

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 IIIII 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, Physicians 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 evaluating a group intervention called Lev-g, designed to promote healthy habits in individuals with neurodevelopmental disorders or those closely related to children with disabilities. This brief, transdiagnostic, interprofessional program addresses health-related habits that influence mental and physical health, aiming to provide a usable model across various healthcare settings in Sweden. The study focuses on understanding the feasibility, acceptability, and potential effects of this intervention in improving health behaviors. Lev-g consists of three group sessions plus a booster session, employing psychoeducation, motivational interviewing, and applied behavioral analyses. The group format aims to provide peer support and sharing of tips among participants. There is no control group, as this trial tests the feasibility of the intervention. The program is delivered in healthcare settings and is intended for adults aged 15 to 80. Participants will be assessed for completion rates, satisfaction, treatment credibility, adverse events, and goal achievement throughout and after the intervention. Evaluations include questionnaires for both participants and healthcare workers at multiple time points up to 3 to 4 months. Researchers will measure well-being, self-efficacy, and changes in health-related habits, tracking progress from baseline through the booster session. The study is expected to conclude by early 2027.

This research focuses on people who have previously been treated with KYV-101, an autologous CAR T cell therapy, to monitor long-term safety and persistence of the treatment. It aims to collect information about delayed side effects and ongoing presence of the gene-modified cells in participants who received at least one infusion of KYV-101 in earlier clinical trials sponsored by Kyverna Therapeutics. Participants in this observational study will continue to be followed for up to 15 years after their initial KYV-101 treatment. The study will track various health outcomes including treatment-related adverse events, new or returning malignancies, neurological and autoimmune conditions, blood disorders, infections, and specific laboratory tests related to the therapy. For some participants with certain conditions, additional measures like medication use and functional assessments will be monitored for shorter periods. Throughout the study, participants will undergo regular health evaluations, lab tests, and questionnaires to assess the long-term effects of KYV-101. Researchers will collect data on safety events and laboratory markers up to 15 years, with some specific tests monitored up to 5 years. The overall goal is to better understand the long-term impact and safety profile of the gene-modified therapy in people treated previously.

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 childs 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.

Researchers are developing a multicenter registry to collect and share data on pediatric patients who have undergone deep brain stimulation DBS for movement disorders such as dystonia, epilepsy, Tourette syndrome, and mood disorders. The study aims to improve understanding of DBS safety and effectiveness in children, as current data are limited and individual centers often have too few cases for strong research. This registry will support large-scale analyses and help refine DBS as a treatment option for hyperkinetic movement disorders in the pediatric population. The study involves gathering both retrospective and prospective clinical data from multiple pediatric centers. The registry will collect information on surgical techniques, patient outcomes, implant sites, and long-term effects of DBS. This collaborative data-sharing approach enables comprehensive evaluation of which patients benefit most from DBS and how it impacts their quality of life over time. Participants include children aged 0 to 18 years who have already received or are scheduled to receive DBS for neurological movement disorders. Data will be collected over five years to monitor safety, efficacy, and quality of life outcomes. The study does not involve treatment administration but focuses on gathering and analyzing clinical information. Parental or legal guardian consent is required for prospective participation.

This research aims to evaluate the feasibility and usefulness of two types of play-based training programs delivered by researchers and caregivers at home or in community settings. These programs focus on improving arm function in children aged 3 to 8 years with hemiplegia, a condition causing weakness on one side of the body. The study compares a joystick-operated powered ride-on toy program called SPEED training with a creative upper extremity training program called CRAFT training, assessing their acceptance, implementation, and impact on arm use and motor skills. Participants will be randomly assigned to either the SPEED or CRAFT training group. The SPEED group uses ride-on toys modified for joystick control on the affected side, involving navigation games and object tasks to encourage arm use. The CRAFT group engages in seated creative motor games, stretching, strengthening, building, and art activities using the affected arm. Training sessions last 30-45 minutes twice weekly for 6 weeks, with caregivers providing two additional 15-20 minute sessions weekly. The ride-on toy is kept at home during the intervention, and families log all training and other therapies received. Before starting, children undergo standardized assessments and wear sensors and activity monitors to track arm use over a week. These evaluations and caregiver questionnaires are repeated after the 6-week intervention and at a 1-month follow-up. Researchers video record sessions for scoring and monitor treatment adherence, retention, satisfaction, and changes in arm function, strength, movement control, and habitual activity. Participation lasts about 12 weeks, including pretests, intervention, posttests, and follow-up assessments.