[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605195":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":56,"collaborators":58,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":19,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":19,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":94,"whyStopped":19,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"MarsiBionics","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CLINICAL EXPLORER","EXPERIMENTAL","An initial assessment (screening visit), 8 intervention sessions (2 per week) in the rehabilitation center, and a final assessment.",[13],"Device: CLINICAL EXPLORER",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","8 sessions of use of the device in the rehabilitation center",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Carlos Cumplido Trasmonte, Clinical Lead","CONTACT","+34918711900","carlos.cumplido@marsibionics.com",[27,42],{"facility":28,"status":19,"city":29,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Asociación Pro Personas con Paralisis Cerebral (APAC-IAP)","Mexico City","06720","Mexico","MX",{"type":34,"coordinates":35},"Point",[36,37],-99.12766,19.42847,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":19,"phoneExt":19,"email":19},"Mayra Patricia Estrella Piñón",{"facility":43,"status":19,"city":44,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":52,"contacts":53},"Hospital Infantil Universitario Niño Jesús-Servicio de Neuro Ortopedia","Madrid","28009","Spain","ES",{"type":34,"coordinates":49},[50,51],-3.70256,40.4165,{"lat":51,"lon":50},[54],{"name":55,"role":23,"phone":19,"phoneExt":19,"email":19},"Ignacio Martínez Caballero",{"type":57,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[59,62],{"name":60,"class":61},"Hospital Infantil Universitario Niño Jesús, Madrid, Spain","OTHER",{"name":63,"class":64},"APAC, I.A.P.","UNKNOWN","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":76,"type":77},60,"ESTIMATED","INTERVENTIONAL",[80],"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 .",[83,84],"Neuromuscular Disorders","Neurodevelopmental Disorders",[86,87,88,89,90,91,92,93],"Neurodevelopmental disorders","Neuromuscular disorders","cerebral palsy","acquired brain injury","spinal muscular atrophy","robotics","gait","spinal cord injury","NOT_YET_RECRUITING","2025-09-03",{"date":97,"type":98},"2025-09-08","ACTUAL",{"date":100,"type":77},"2025-09-15",{"date":102,"type":77},"2026-06-01",{"name":5,"class":6},2]