Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-02-25 @ 11:04 PM
Study NCT ID:
NCT06894160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Usability of the EXPLORER Exoskeleton in Adults With Neuromuscular Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2025-03-06', 'studyFirstSubmitQcDate': '2025-03-18', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serious Adverse Events', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'Occurrence of any serious adverse event to the participant or the caregiver'}, {'measure': 'Falls prevalence', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'Number of falling events occurred from the participant or caregiver'}, {'measure': 'Heart Rate', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'Beats per minute'}, {'measure': 'Skin integrity', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'Occurrence of any injury of the skin in the areas of contact and produced by the use of the device'}, {'measure': 'Device usage time', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'Time using the device'}, {'measure': 'Level of Spasticity', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'Evaluation of spasticity with Modified Ahsworth Scale'}, {'measure': 'Level of fatigue', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'Fatigue of both the participant and the therapist, Measured with the Borg scale'}, {'measure': 'Donning and doffing time', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'Time to don and doff the device to each participant'}, {'measure': 'Level of assistance a participant requires for walking', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'Measure with FAC scale'}, {'measure': 'Walking ability of individuals with spinal cord injuries', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'Measure with WISCII (SCI) scale'}, {'measure': 'TUG', 'timeFrame': 'Through study completion, an average of 1 month', 'description': "The Time Up and Go test is used to assess a participant's mobility and balance"}, {'measure': '10MWT', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'The 10-Meter Walk Test is used to assess walking speed by measuring the time taken to walk 10 meters at a comfortable pace.'}, {'measure': 'QUEST 2.0', 'timeFrame': 'at the end of the intervention, an average of 1 month', 'description': "Using the Quebec User Evaluation of Satisfaction with Assistive Technology 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"}, {'measure': 'Blood Pressure', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'Measure in mmHg'}, {'measure': 'Oxygen Saturation', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'It analyzes this absorption and calculates the SpO₂'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gait', 'robotics', 'neuromuscular disorders', 'rehabilitation'], 'conditions': ['Neuromuscular Disorders']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis study will involve testing the gait-assistance exoskeleton in healthy patients during the first phase, and in patients with stroke (ACV), acquired brain injury (DCA), multiple sclerosis (EM), and muscular dystrophy (LM) during the second phase. The study will consist of two phases:\n\nPhase 1: One visit with the device in healthy patients to assess the initial safety and comfort of the device.\n\nPhase 2: A screening visit (S0) followed by two treatment visits with the device (V1-V2) in patients with ACV, DCA, EM, and LM to determine the effectiveness of the device in treating motor impairments caused by these conditions.\n\nThe goal of the study is to evaluate the safety and usability of the device in patients with ACV, DCA, EM, and LM, in order to identify potential benefits in improving gait, muscle strength, and overall functionality in this patient group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria related to the device characteristics:\n\n* Weight \\< 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 \\< 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 \\< 4.\n* WISCI II score in participants with MD \\< 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/or 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.'}, 'identificationModule': {'nctId': 'NCT06894160', 'briefTitle': 'Safety and Usability of the EXPLORER Exoskeleton in Adults With Neuromuscular Diseases', 'organization': {'class': 'INDUSTRY', 'fullName': 'MarsiBionics'}, 'officialTitle': 'Safety and Usability of Adults EXPLORER Exoskeleton in With Neuromuscular Diseases', 'orgStudyIdInfo': {'id': 'EXP-A-US'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adults EXPLORER', 'description': 'Two sessions with the robotic gait device in patients with neuromuscular diseases.', 'interventionNames': ['Device: Adults EXPLORER']}], 'interventions': [{'name': 'Adults EXPLORER', 'type': 'DEVICE', 'description': 'Two sessions with the robotic gait device in patients with neuromuscular diseases.', 'armGroupLabels': ['Adults EXPLORER']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28046', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'David Hernández Herrero', 'role': 'CONTACT', 'email': 'dhernandez.herrero@salud.madrid.org', 'phone': '679645714'}], 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Carlos Cumplido Trasmonte', 'role': 'CONTACT', 'email': 'carlos.cumplido@marsibionics.com', 'phone': '+34918711900'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MarsiBionics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}