[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"MarsiBionics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":106},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100605195","safety-usability-and-effectiveness-of-a-gait-exoskeleton-for-children-and-adolescents-with-neurodevelopmental-disorders-100605195",false,"NCT07159360","Safety, Usability, and Effectiveness of a Gait Exoskeleton for Children and Adolescents With Neurodevelopmental Disorders.","Inclusion Criteria for Phase 0\n\n* Age between 2 and 17 years.\n* Consent from the participant or legal guardian to participate in the study.\n* No diagnosis of neurodevelopmental disorders such as CP, NMD, LM, or MS. Inclusion Criteria for Phase 1\n* Age between 2 and 17 years.\n* Consent from the participant or legal guardian to participate in the study.\n* Diagnosis of neurodevelopmental disorders such as CP, NMD, LM, or MS. Inclusion Criteria Related to the EXPLORER CLINICAL Device Characteristics\n* Medical authorization to stand upright and perform weight-bearing gait training.\n* Weight less than or equal to 60 kg.\n* Hip width less than or equal to 40 cm.\n* Distance from the hip joint center to the knee joint center: 21 cm - 36 cm.\n* Distance from the knee joint center to the ankle joint center: 20 - 35 cm.\n* EU shoe size less than or equal to 40.\n\nExclusion Criteria:\n\n* Any medical contraindication for standing or walking.\n* Presence of non-reducible contractures or heterotopic ossification above the degrees allowed by the device and\u002For outside the trajectory imposed by the device.\n* Spasticity (MAS) = 4 in lower limbs at the time of device use.\n* Structured hip and\u002For knee contracture greater than 20 degrees.\n* Inability to stand or walk with more than 5 degrees of hip abduction.\n* Inability to achieve 5 degrees of dorsal ankle flexion from the neutral position with or without orthosis.\n* Tibial leg length discrepancy that cannot be mitigated with the use of a foot wedge.\n* Skin alterations in areas of contact with the device.\n* History of fracture without trauma.\n* Presence of other conditions that cause exercise intolerance (such as uncontrolled hypertension, coronary artery diseases, arrhythmia, congestive heart failure, severe pulmonary disease).\n* Behavioral disorders that interfere with proper use of the device, such as impulsivity.\n* Allergy to any of the materials of the EXPLORER CLÍNICO: cotton, nylon, polyester, PPS, PEEK, or ABS. The materials used in EXPLORER CLÍNICO that were not previously used in ATLAS 2030, a medical device certified by the AEMPS, are PPS, PEEK, and ABS.",true,"ALL","2 Years","17 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","Neurodevelopmental disorders often result in abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as the inability to stand and walk. CLINICAL EXPLORER is a clinical-use robotic device for gait training, representing the evolution of the ATLAS 2030 exoskeleton and the EXPLORER device for home use. The aim of this study is to evaluate the safety and usability of CLINICAL EXPLORER .",[27,28],"Neuromuscular Disorders","Neurodevelopmental Disorders",[30,31,32,33,34,35,36,37],"Neurodevelopmental disorders","Neuromuscular disorders","cerebral palsy","acquired brain injury","spinal muscular atrophy","robotics","gait","spinal cord injury","NOT_YET_RECRUITING","2025-09-03",{"date":41,"type":42},"2025-09-08","ACTUAL",{"date":44,"type":21},"2025-09-15",{"date":46,"type":21},"2026-06-01",{"name":48,"class":49},"MarsiBionics","INDUSTRY",2,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100575422","safety-and-usability-of-the-atlas-2030-exoskeleton-in-pediatric-patients-with-spinal-cord-injury-100575422","NCT06772077","Safety and Usability of the ATLAS 2030 Exoskeleton in Pediatric Patients With Spinal Cord Injury","Inclusion Criteria:\n\n* Having a subacute or chronic spinal cord injury (SCI) and being clinically stable with a general condition good enough to participate in the therapeutic program with the ATLAS 2030.\n* Age between 3 and 14 years.\n* Medical authorization to perform standing and gait training with weight-bearing.\n* Consent from the participant or legal guardian to participate in the study.\n* Adequate level of acceptance and commitment from the family.\n\nInclusion criteria related to device characteristics:\n\n* Weight ≤ 35 kg.\n* Hip width ≤ 34 cm. It is advised that for measurements under 28 cm, verification should be performed to ensure there is no excessive base of support that might induce foot inversion in the standing position.\n* Femur length (distance from the greater trochanter to the lateral condyle of the femur) between 24 cm and 33 cm. Femur lengths shorter than 24 cm are acceptable as long as the hip motor of the device does not extend above the user's iliac crest, avoiding hypermobility of the lumbar spine.\n* Tibia length (distance from the lateral condyle to the lateral malleolus of the tibia) between 23 cm and 32 cm. Tibia lengths shorter than 23 cm are acceptable as long as they can be compensated with a lift and the user's ankle joint remains within the area of the ankle motor.\n* EU shoe size between 27 and 33.\n\nExclusion Criteria:\n\n* Impossibility for the family to complete treatment schedule planning.\n* Any contraindication for standing and\u002For walking.\n* Spasticity (Modified Ashworth Scale (MAS) = 4 in the lower limbs at the time of device use).\n* Joint contracture of the hip and\u002For knee \\> 20 degrees.\n* Need to walk with more than 9 degrees of hip abduction.\n* Need to walk with more than 9 degrees of dorsal or plantar ankle flexion, or inability to use an orthosis to achieve 90° at the ankle.\n* Severe skin lesions in areas of contact with the device.\n* Planned surgical intervention during the study period or previous orthopedic surgery on the spine and\u002For lower limbs contraindicating treatment.\n* Known advanced osteoporosis evidenced by bone densitometry, particularly with a history of prior fractures or fractures without trauma. Traumatic bone fractures in the lower limbs or pelvic girdle within the past 6 months.\n* Unstable fractures, joint dislocations, or other joint pathologies in the trunk and lower limbs contraindicating the treatment.\n* Severe rigid orthopedic deformities of the spine that prevent the use of the device.\n* Presence of frequent seizures, uncontrolled epilepsy, or difficult-to-control behavioral disorders.\n* Presence of decompensated heart or lung disease, or any other condition causing exercise intolerance.\n* Allergy to any of the materials used in the ATLAS 2030: cotton, nylon, polyester, polyamide, polyethylene, or polypropylene.","3 Years","14 Years",{"count":60,"type":21},20,[24],"The goal of this clinical trial is to analyze the usability and safety of the robotic gait ATLAS 2030 in a cohort of pediatric patients with Spinal Cord Injury, with the aim of extending its indication for use to pediatric spinal cord injury",[64],"Spinal Cord Injury (SCI)",[66,67,35,68,69,70],"Spinal Cord Injury","Rehabilitation","Gait Exoskeleton","children","ATLAS2030","RECRUITING","2025-08-11",{"date":74,"type":42},"2025-08-14",{"date":76,"type":42},"2025-02-17",{"date":78,"type":21},"2026-02-01",{"name":48,"class":49},1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":15,"sex":16,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":80},"100584807","safety-and-usability-of-the-explorer-exoskeleton-in-adults-with-neuromuscular-diseases-100584807","NCT06894160","Safety and Usability of the EXPLORER Exoskeleton in Adults With Neuromuscular Diseases","Safety and Usability of Adults EXPLORER Exoskeleton in With Neuromuscular Diseases","Inclusion criteria related to the device characteristics:\n\n* Weight \\\u003C 100 kg.\n* Hip width between 30 - 45 cm.\n* Distance from the hip joint center to the knee joint center: 36 cm - 50 cm.\n* Distance from the knee joint center to the floor: 43.5 cm - 59.5 cm.\n* Patients must be able to follow simple instructions.\n* MAS \\\u003C 3 in lower limbs.\n* EU shoe size between 36 and 45.\n* Absence of pathology affecting movement (only valid for phase 1 of the current study).\n\nInclusion criteria related to the study:\n\n* Age 18-85 years.\n* Diagnosis of stroke (ACV), acquired brain injury (DCA), multiple sclerosis (EM), muscular dystrophy (LM), or cerebral palsy (PC).\n* Gait difficulty: those who require assistance to walk using technical aids, assistance, or supervision from others.\n* FAC score in participants with DCA, stroke, or MS \\\u003C 4.\n* WISCI II score in participants with MD \\\u003C 20.\n\nExclusion Criteria:\n\n* Spasticity (MAS) = 3 in lower limbs.\n* Skin alterations in the areas of contact with the device.\n* Planned surgical intervention during the study duration.\n* Two or more osteoporotic fractures in the lower limbs in the last 2 years.\n* Presence of other conditions that cause exercise intolerance (such as uncontrolled hypertension, coronary artery diseases, arrhythmia, congestive heart failure, severe lung disease).\n* Surgical operation in the 3 months prior to the start of the study on the limbs and\u002For spine.\n* Psychiatric disorders that interfere with proper use of the device or participation in the study, such as impulsivity or inability to understand simple instructions.","18 Years","85 Years",{"count":91,"type":21},7,[24],"Neurodevelopmental disorders frequently result in abnormal development of the Central Nervous System (CNS), often leading to motor impairments such as difficulty in standing and walking. EXPLORER is a robotic exoskeleton for gait rehabilitation, specifically designed for adults aged 18 to 85 with motor disabilities.The aim of this study is to evaluate the safety and usability of the EXPLORER for adults with motor disability.",[27],[36,35,96,97],"neuromuscular disorders","rehabilitation","2025-06-03",{"date":100,"type":42},"2025-06-04",{"date":102,"type":21},"2025-07-01",{"date":104,"type":21},"2025-08-01",{"name":48,"class":49},""]