Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-01-18 @ 4:50 PM
Study NCT ID:
NCT07159360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Usability, and Effectiveness of a Gait Exoskeleton for Children and Adolescents With Neurodevelopmental Disorders.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D009134', 'term': 'Muscular Atrophy, Spinal'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2025-05-23', 'studyFirstSubmitQcDate': '2025-09-03', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serious Adverse Events', 'timeFrame': 'through study completion, along 8 weeks', 'description': 'occurrence of any serious adverse event to the participant or the caregiver'}, {'measure': 'Falls prevalence', 'timeFrame': 'through study completion, along 8 weeks', 'description': 'Number of falling events occurred from the participant or caregiver'}, {'measure': 'Skin integrity', 'timeFrame': 'through study completion, along 8 weeks', 'description': 'Occurrence of any injury of the skin in the areas of contact and produced by the use of the device'}, {'measure': 'Pain (Visual Analogic Scale)', 'timeFrame': 'through study completion, along 8 weeks', 'description': 'pain measured by the Visual Analogic Scale (VAS) by the participant and the caregiver, scored from 0 to 10, being 0 "no pain" and 10 "unbearable pain"'}, {'measure': 'Heart rate', 'timeFrame': 'through study completion, along 8 weeks', 'description': 'measurement of heart rate with a smart band'}, {'measure': 'Oxygen saturation', 'timeFrame': 'through study completion, along 8 weeks', 'description': 'measurement of Oxygen saturation with a smart band'}, {'measure': 'Blood pressure', 'timeFrame': 'through study completion, along 8 weeks', 'description': 'measurement of blood pressure with a smart band'}, {'measure': 'Donning and doffing time', 'timeFrame': 'through study completion, along 8 weeks', 'description': 'Time to don and doff the device to each participant'}, {'measure': 'QUEST', 'timeFrame': 'at the end of the intervention at 8 weeks', 'description': "Using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) questionnaire administered to the participants' caregivers at the end of the intervention. The QUEST 2.0 scale has 12 items. Each item is rated on a 5-point Likert scale"}], 'secondaryOutcomes': [{'measure': 'Gait analysis', 'timeFrame': 'Day 1 and at the end of the intervention at 8 weeks', 'description': 'Spatiotemporal parameters will be done through photogrammetry.'}, {'measure': 'Range of motion', 'timeFrame': 'Day 1 and at the end of the intervention at 8 weeks', 'description': 'Passive Degree to which a joint can move (hip, knee, and ankle joints in both legs). From 0º to 180º.'}, {'measure': 'Quality of life (EQ-5D)', 'timeFrame': 'Day 1 and at the end of the intervention at 8 weeks', 'description': 'The EQ-5D is a standardized instrument used to measure and evaluate the quality of life. It assesses five key dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 3-level or 5-level scale, reflecting the severity of the condition (e.g., no problems, some problems, or extreme problems). The EQ-5D also includes a visual analogue scale (VAS) where individuals rate their overall health on a scale from 0 to 100. The tool is widely used in clinical trials, health surveys, and economic evaluations to assess health-related quality of life and make comparisons across different patient populations or interventions.'}, {'measure': 'Level of fatigue', 'timeFrame': 'through study completion, along 8 weeks', 'description': 'Fatigue of both the participant and the therapist, Measured with the Borg scale'}, {'measure': 'Level of Spasticity', 'timeFrame': 'Day 1 and through study completion, along 8 weeks', 'description': 'Evaluation of spasticity with Modified Ahsworth Scale'}, {'measure': 'Muscular activity (EMG)', 'timeFrame': 'through study completion, along 8 weeks', 'description': 'EMG (Electromyography) is a technique that measures the electrical activity of muscles to assess their function. It helps detect neuromuscular disorders and evaluate muscle activation patterns, using either surface electrodes or needle inserts to record muscle activity. Measured with the system FREEEMG/BTS®.'}, {'measure': 'Cerebral activity (EEG)', 'timeFrame': 'through study completion, along 8 weeks', 'description': 'EEG (Electroencephalography) is a method used to record electrical activity in the brain. It involves placing electrodes on the scalp to measure brain wave patterns, helping to diagnose conditions like epilepsy, sleep disorders, and brain injuries. Measured with Enobio® EEG systems.'}, {'measure': 'Acceptability', 'timeFrame': 'at the end of the intervention, 8th week', 'description': 'Analysis of the drop-out rate during the study period'}, {'measure': 'Accessibility of the participant', 'timeFrame': 'through study completion, along 8 weeks', 'description': 'Rate of the participants suitable to use the device'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neurodevelopmental disorders', 'Neuromuscular disorders', 'cerebral palsy', 'acquired brain injury', 'spinal muscular atrophy', 'robotics', 'gait', 'spinal cord injury'], 'conditions': ['Neuromuscular Disorders', 'Neurodevelopmental Disorders']}, 'descriptionModule': {'briefSummary': '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 .', 'detailedDescription': "Neuromuscular and neurological disorders in children cause muscle weakness and spasticity, leading to severe motor dysfunctions such as the inability to maintain posture or walk. Manually assisted gait training can be physically demanding for therapists, which is why robotic devices have been developed to reduce their workload, provide objective assessments through integrated sensors, and improve rehabilitation quality. Beyond mobilizing muscles and joints, these devices enhance brain neuroplasticity and the child's connectivity with their environment, positively impacting self-esteem and social interaction. A clinical-use robotic device for gait training has been developed, representing the evolution of the ATLAS 2030 exoskeleton and the EXPLORER device for home use."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '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/or outside the trajectory imposed by the device.\n* Spasticity (MAS) = 4 in lower limbs at the time of device use.\n* Structured hip and/or 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.'}, 'identificationModule': {'nctId': 'NCT07159360', 'briefTitle': 'Safety, Usability, and Effectiveness of a Gait Exoskeleton for Children and Adolescents With Neurodevelopmental Disorders.', 'organization': {'class': 'INDUSTRY', 'fullName': 'MarsiBionics'}, 'officialTitle': 'Safety, Usability, and Effectiveness of a Gait Exoskeleton for Children and Adolescents With Neurodevelopmental Disorders.', 'orgStudyIdInfo': {'id': 'EXC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CLINICAL EXPLORER', 'description': 'An initial assessment (screening visit), 8 intervention sessions (2 per week) in the rehabilitation center, and a final assessment.', 'interventionNames': ['Device: CLINICAL EXPLORER']}], 'interventions': [{'name': 'CLINICAL EXPLORER', 'type': 'DEVICE', 'description': '8 sessions of use of the device in the rehabilitation center', 'armGroupLabels': ['CLINICAL EXPLORER']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06720', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'contacts': [{'name': 'Mayra Patricia Estrella Piñón', 'role': 'CONTACT'}], 'facility': 'Asociación Pro Personas con Paralisis Cerebral (APAC-IAP)', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '28009', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Ignacio Martínez Caballero', 'role': 'CONTACT'}], 'facility': 'Hospital Infantil Universitario Niño Jesús-Servicio de Neuro Ortopedia', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Carlos Cumplido Trasmonte, Clinical Lead', 'role': 'CONTACT', 'email': 'carlos.cumplido@marsibionics.com', 'phone': '+34918711900'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MarsiBionics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hospital Infantil Universitario Niño Jesús, Madrid, Spain', 'class': 'OTHER'}, {'name': 'APAC, I.A.P.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}