Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT03223051
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2017-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Space Exploration Assessment for Children With Spinal Muscular Atrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009134', 'term': 'Muscular Atrophy, Spinal'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-22', 'studyFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2017-07-18', 'lastUpdatePostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor Function Measure (MFM)', 'timeFrame': '1 hour', 'description': 'Clinical Evaluation'}], 'secondaryOutcomes': [{'measure': 'Space Exploration Test (SET)', 'timeFrame': '20 minutes', 'description': 'The SET is made through a test board 170 cm long and 60 cm deep, developed by in our lab'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spinal Muscular Atrophy', 'Children', 'Motor assessment', 'Space exploration', 'Upper limbs'], 'conditions': ['Spinal Muscular Atrophy', 'Assessment, Self']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized study is to develop a new motor assessment of space exploration in a 2D environment with upper limbs for children with spinal muscular atrophy 1 and 2 from 3 until 16 years old.', 'detailedDescription': 'Thirty children are included in the prospective randomized study. They are evaluated with the new test, Space Exploration Test (TES), and with the Motor Function Measure (MFM), a gold standard scale. The objective is to compare the results and to demonstrate the complementarity of the two tools.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children, girls and boys, from 3 to 16 years old,\n* with Spinal Motor Atrophy 1 and 2\n* with social protection\n\nExclusion Criteria:\n\n* cognitive disorders preventing understanding'}, 'identificationModule': {'nctId': 'NCT03223051', 'acronym': 'ExplorASI', 'briefTitle': 'Development of a Space Exploration Assessment for Children With Spinal Muscular Atrophy', 'organization': {'class': 'OTHER', 'fullName': "Centre d'Investigation Clinique et Technologique 805"}, 'officialTitle': 'Development of a Space Exploration Assessment for Children With Spinal Muscular Atrophy', 'orgStudyIdInfo': {'id': '2017-A01017-46'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evaluation', 'description': 'Included patients will be invited to participate in 1 session, to be evaluated with the Motor Function Measure and the new test of space exploration, during 2 hours maximum, to compare scores with these 2 tests.\n\nAn occupational therapist will be required to install the patient in front of the table and to give the instructions.', 'interventionNames': ['Other: Motor assessment']}], 'interventions': [{'name': 'Motor assessment', 'type': 'OTHER', 'description': 'An occupational therapist install the patient sitting in front of the test board and tell him the instructions', 'armGroupLabels': ['Evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'Hopital Raymond Poincare', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'Nicolas ROCHE, Md PhD', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'overallOfficials': [{'name': 'Nicolas ROCHE, MDphD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Raymond Poincare HOSPITAL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre d'Investigation Clinique et Technologique 805", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}