Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:13 PM
Study NCT ID:
NCT06939634
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2025-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Usability and Safety of the System Atalante in Patients With High Paraplegia and Tetraplegia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D011782', 'term': 'Quadriplegia'}, {'id': 'D010264', 'term': 'Paraplegia'}, {'id': 'D020275', 'term': 'Guillain-Barre Syndrome'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011129', 'term': 'Polyradiculoneuropathy'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2025-03-04', 'studyFirstSubmitQcDate': '2025-04-14', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Descriptive data: Age', 'timeFrame': 'Baseline, up to 101 weeks.', 'description': 'To characterize the population, for each patient, the age will be collected when available (years).'}, {'measure': 'Descriptive data: Gender', 'timeFrame': 'Baseline, up to 101 weeks.', 'description': 'To characterize the population, for each patient, the gender will be collected when available (male, female).'}, {'measure': 'Descriptive data: Cause and time since injury or pathology', 'timeFrame': 'Baseline, up to 101 weeks.', 'description': 'To characterize the population, for each patient, the cause of injury or pathology, the time since injury or diagnosis (years) will be collected when available.'}, {'measure': 'Descriptive data: Urinary status', 'timeFrame': 'Baseline, up to 101 weeks.', 'description': 'To characterize the population, for each patient, the urinary status will be collected when available:\n\n* Intermittent catherization\n* Indwelling catherization\n* External collection device\n* Other'}, {'measure': 'Descriptive data: Bowel status', 'timeFrame': 'Baseline, up to 101 weeks.', 'description': 'To characterize the population, for each patient, the bowel status will be collected when available:\n\n* Digital stimulation\n* Manual evacuation\n* Colostomy\n* Other'}, {'measure': 'Descriptive data: Severity of the lesion using the International Standards for Neurological Classification of SCI', 'timeFrame': 'Baseline, up to 101 weeks.', 'description': 'To characterize the population, for each patient, the following descriptive data will be collected when available:\n\n* ASIA impairement scale: A (complete), B (sensory incomplete), C and D (motor incomplete), E (normal).\n* Neurological Level of Injury'}, {'measure': 'Descriptive data: Cardiorespiratory parameters', 'timeFrame': 'Baseline, up to 101 weeks.', 'description': 'To characterize the population, for each patient, cardiorespiratory parameters including Heart Rate (HR) in Beats per minute and Blood Pressure (BP) in mmHg will be collected when available.'}, {'measure': 'Descriptive data: Pain', 'timeFrame': 'Baseline, up to 101 weeks.', 'description': 'To characterize the population, for each patient, intensity of the pain using the subjective Numeric Pain Rating Scale (NPRS) will be collected when available: from 0 (no pain) to 10 (worst possible pain).'}, {'measure': 'Descriptive data: Bone health', 'timeFrame': 'Baseline, up to 101 weeks.', 'description': 'To characterize the study population, bone health data will be collected for each patient, when available, including:\n\n* T-score values ranging from 0 (normal) to below -2.5 (indicative of osteoporosis)\n* Bone Mineral Density (BMD) measurements expressed in g/cm²'}, {'measure': 'Reasons for discontinuing sessions', 'timeFrame': 'Post-intervention (up to 101 weeks)', 'description': "The reason(s) for discontinuing sessions may include hospital discharge, patient's decision, pain or discomfort, achievement of goals set by the therapeutic team, etc."}], 'primaryOutcomes': [{'measure': 'Safety through the collection of the reported adverse device effects', 'timeFrame': 'Baseline, up to 101 weeks.', 'description': 'Measured through all reported adverse device effects (ADEs). ADEs are categorized into the following categories: musculoskeletal, cutaneous (skin abrasion), cardiovascular (orthostatic hypotension), pain, falls, and fractures and are further characterized as minor or serious based on the nature and the severity of the adverse event (AE).'}], 'secondaryOutcomes': [{'measure': 'Spasticity assessment', 'timeFrame': 'Baseline, post-intervention (up to 101 weeks)', 'description': 'This may involve the use of the Modified Ashworth Scale or a general description of spasticity recorded in the medical file.'}, {'measure': 'Walking ability', 'timeFrame': 'Baseline, post-intervention (up to 101 weeks)', 'description': 'This may involve Walking Index for Spinal Cord Injury, version II (WISCI II) assessing the amount of physical assistance needed, as well as devices required, for walking following paralysis that results from SCI. It ranges from 0 (unable to stand and/or participate in assisted walking) to 20 (ambulates with no devices, no braces and no physical assistance, 10 meters).'}, {'measure': 'Walking speed', 'timeFrame': 'Baseline, post-intervention (up to 101 weeks)', 'description': 'This may involve 10 meters walk test (10MWT) measuring gait speed during a 10-meter walk during comfortable and rapid pace.'}, {'measure': 'Mobility, balance, walking ability, and fall', 'timeFrame': 'Baseline, post-intervention (up to 101 weeks)', 'description': 'This may involve Time Up and Go (TUG), a timed task where the patient is asked to stand up from the chair, walk 3 meters, turn around, walk and sit again.'}, {'measure': 'Endurance', 'timeFrame': 'Baseline, post-intervention (up to 101 weeks)', 'description': "This may involve 6-minutes' walk test (6MWT) and 2-minutes' walk test (2MWT) measuring the walked distance during a 6- or 2-minutes' walk."}, {'measure': 'Balance', 'timeFrame': 'Baseline, post-intervention (up to 101 weeks)', 'description': 'This may involve Berg Balance Scale (BBS) including items include static and dynamic activities of varying difficulty.'}, {'measure': 'Independance', 'timeFrame': 'Baseline, post-intervention (up to 101 weeks)', 'description': 'This may involve Spinal Cord Independence Measure (SCIM III) including items assessing self-care, respiration and sphincter management.'}, {'measure': 'Usability assessment', 'timeFrame': 'Post-intervention (up to 101 weeks)', 'description': 'The assessment of the usability will be asked to the operators in charge of the rehabilitation of the patients included in this study. It includes a usability questionnaire and session data collection.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hands-free Exoskeleton', 'Atalante X', 'Atalante', 'Rehabilitation', 'Safety'], 'conditions': ['Spinal Cord Injury', 'Tetraplegia/Tetraparesis', 'Paraplegia, Complete', 'Paraplegia, Incomplete', 'Guillain Barré Syndrome']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical trial is to determine whether the Atalante X exoskeleton can be safely utilized by patients with tetraplegia and high paraplegia (at or above T4).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population includes people with high paraplegia and tetraplegia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years old,\n* Tetraplegia or high paraplegia (at or above T4) regardless of the cause,\n* Non-opposition to the participation to the study,\n* Having undergone a minimum of 1 session with the Atalante device from February 2019, to now.\n\nExclusion Criteria:\n\n* Neurological Level of Injury below T4 as determined by the International Standards for Neurological Classification of SCI'}, 'identificationModule': {'nctId': 'NCT06939634', 'acronym': 'QUATRO', 'briefTitle': 'Evaluation of Usability and Safety of the System Atalante in Patients With High Paraplegia and Tetraplegia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wandercraft'}, 'officialTitle': 'Evaluation of Usability and Safety of the System Atalante in Patients With High Paraplegia and Tetraplegia', 'orgStudyIdInfo': {'id': 'CIP009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hands-free exoskeleton', 'description': 'Patient with high paraplegia or tetraplegia who have undergone at least one session with the exoskeleton.', 'interventionNames': ['Device: Hands-free exoskeleton']}], 'interventions': [{'name': 'Hands-free exoskeleton', 'type': 'DEVICE', 'description': 'Having undergone at least on session with Atalante exoskeleton. Clinical, safety and session data are collected retrospectively.', 'armGroupLabels': ['Hands-free exoskeleton']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62600', 'city': 'Berck', 'state': 'France', 'country': 'France', 'facility': 'Fondation Hopale', 'geoPoint': {'lat': 50.4, 'lon': 1.6}}, {'zip': '63330', 'city': 'Pionsat', 'state': 'France', 'country': 'France', 'facility': 'CMPR de Pionsat', 'geoPoint': {'lat': 46.10963, 'lon': 2.69319}}, {'zip': '27180', 'city': 'Saint-Sébastien-de-Morsent', 'state': 'France', 'country': 'France', 'facility': 'Hôpital La Musse', 'geoPoint': {'lat': 49.01096, 'lon': 1.0873}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wandercraft', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}