[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"COSMO ROBOTICS CO., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100634415","safety-and-effectiveness-of-bambini-kids-robot-assisted-gait-training-ragt-in-children-with-cerebral-palsy-100634415",false,"NCT07539389","Safety and Effectiveness of Bambini Kids Robot-Assisted Gait Training (RAGT) in Children With Cerebral Palsy","Safety and Effectiveness of Bambini Kids Robot-Assisted Gait Training in Children With Cerebral Palsy: A Randomized Clinical Trial","Inclusion Criteria:\n\nSubjects eligible for participation in this clinical investigation shall meet all of the following criteria.\n\n* Patient diagnosed with Cerebral Palsy\n* Age from 2 to 10 years old\n* Classified as Levels II to IV according to GMFCS\n* Manual Muscle Testing, MMT score of 0 to 4\n* Modified Ashworth Scale, MAS score of 3 and under\n* Subjects with sufficient cognitive function to comply with study procedures\n* Subjects with adequate upper limb function required for device use and study procedures\n* Subjects who meet the physical requirements for use of the medical device as defined by the manufacturer\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria are not eligible for participation in the clinical investigation.\n\n* Subjects who do not meet the criteria of age, height, weight, body dimensions, or joint range of motion\n* Subjects with skin lesions, pressure sores, infections, or other conditions at area where device touches and makes difficult to use device\n* Classified as Levels V according to GMFCS\n* Subjects with severe spasticity (MAS \\> 3), or those at risk of significant worsening of spasticity after training.\n* Subjects unable to maintain an upright standing position for at least 15 minutes (e.g., due to autonomic dysreflexia or orthostatic hypotension)\n* Subjects with significant cardiovascular disease or a history of myocardial infarction within the past 6 months\n* Subjects with medical conditions that are contraindications for use of the medical device as defined by the manufacturer.\n* Subjects for whom weight-bearing, standing, or gait training is medically contraindicated (e.g., fractures, severe osteoporosis, severe joint deformity, or joint instability)\n* Subjects who have received treatments affecting muscle tone within the past 4 months, such as botulinum toxin injections or baclofen pump implantation\n* Subjects who experience adverse events or undesirable side effects during the clinical investigation that make continued participation difficult\n* Subjects whom the investigator judges to be unsuitable for participation or continuation in the clinical investigation.","ALL","2 Years","10 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","Cerebral palsy (CP) is a common cause of gait impairment in children, leading to limitations in mobility and daily activities. Although conventional physical therapy is widely used, it has limitations in delivering consistent and intensive training. Robot-assisted gait training (RAGT) has emerged as a promising approach to provide repetitive, high-intensity, and task-specific training, with potential benefits in gait function and motor performance.\n\nThe Bambini Kids exoskeleton is a pediatric robotic device designed to assist lower-limb movements, including hip, knee, and ankle joints, to facilitate more natural gait patterns.\n\nThis study aims to evaluate the safety and clinical performance of Bambini Kids in children with cerebral palsy and to generate clinical evidence to support its use in real-world rehabilitation settings.",[27],"Cerebral Palsy (CP)","RECRUITING","2026-04-13",{"date":31,"type":32},"2026-04-20","ACTUAL",{"date":29,"type":21},{"date":35,"type":21},"2026-12-31",{"name":37,"class":38},"COSMO ROBOTICS CO., Ltd","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":53,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":39},"100604239","evaluating-the-bambini-teens-exoskeleton-for-pediatric-cerebral-palsy-100604239","NCT07146932","Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy","Inclusion Criteria:\n\n* Between the age of 5 and 14 years and diagnosed with cerebral palsy;\n* have joint range of motion within normal functional limits for ambulation as determined by study staff;\n* Be able and willing to comply with study procedures, including follow-up requirements;\n* Patient cognitive status and ability to communicate must be at a level consistent with that required to participate in standard motor rehabilitation;\n* can follow directions as determined by study staff;\n* be able to physically fit into exoskeleton device; height from 110 to 160 cm (43 to 62 inches) and weighing up less than 65 kg (145 lbs);\n* be able to walk 10 meters with the aid of a walking assistive device and\u002For a single human assistant;\n* bilateral lower limb spasticity that allows lower limb range of motion within the device.\n\nExclusion Criteria:\n\n* any medical issue that precludes full weight-bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity);\n* skin issues that would prevent wearing the device;\n* pre-existing condition that caused exercise intolerance;\n* uncontrolled seizure disorder, spasticity or joint contracture that would interfere with walking;\n* neuromuscular, neurological, cardiovascular or orthopedic pathologies that will interfere with neuromuscular function, ambulation, or limit the range of motion of the lower limbs;\n* severe spasticity (Modified Ashworth Scale = or \\> 3);\n* hip extension range of motion \\\u003C 0 degrees, knee flexion contracture \\> 20 degrees, knee valgus \\> 40 degrees, 2 or more fractures within the past year, hip subluxation (\\> 40% migration),\n* existing Baclofen pump, and\u002For Botox injections within the past 4 months of study enrollment;","5 Years","14 Years",{"count":49,"type":21},20,[24],"The goal of this clinical trial is to evaluate the safety and effectiveness of the Bambini Teens exoskeleton as a gait training tool in children aged 5 to 14 years diagnosed with cerebral palsy (CP). The main questions it aims to answer are:\n\n* Is the Bambini Teens exoskeleton device safe and feasible as a gait training intervention for children with cerebral palsy, without resulting in a significant incidence of device-related serious adverse events?\n* Is it feasible for physical therapists to use the Bambini Teens exoskeleton as a gait training intervention for children with cerebral palsy, meaning participants will successfully complete the training sessions?\n* Will participants' mobility, specifically their self-selected walking speed, improve after receiving gait training using the Bambini Teens exoskeleton compared to baseline measurements?\n\nResearchers will compare participants' mobility measured at baseline to their mobility after the intervention to see if improvements occur.\n\nParticipants will:\n\n* Complete 6 gait training sessions using the Bambini Pediatric Exoskeleton, monitored by a licensed physical therapist.\n* Each training session will be 30 minutes long, conducted 2-3 times per week for approximately 3 weeks.\n* Undergo evaluations at baseline and post-intervention (after approximately 3 weeks), with each evaluation session lasting approximately 2 hours.\n* May also participate in optional motor evaluations.",[27],[54,55,56,57,58,59],"Bambini Teens","Cerebral Palsy","Exoskeleton","ExoAtlet","Cosmo Robotics","Wearable Robotic Devices","NOT_YET_RECRUITING","2025-09-17",{"date":63,"type":32},"2025-09-22",{"date":65,"type":21},"2025-10",{"date":67,"type":21},"2026-01",{"name":37,"class":38},""]