Ignite Creation Date:
2025-12-17 @ 2:47 PM
Ignite Modification Date:
2025-12-23 @ 4:54 PM
Study NCT ID:
NCT04126395
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2019-10-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Explorative RVA of the Motor Development of Children With DCD <2y
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019957', 'term': 'Motor Skills Disorders'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-20', 'studyFirstSubmitDate': '2019-10-11', 'studyFirstSubmitQcDate': '2019-10-11', 'lastUpdatePostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Observable Movement Quality Scale', 'timeFrame': '0-2years', 'description': 'The OMQ is a standardized 15-item observational scale to asses the movement quality. A maximum of two 5-minute compilations are assembled per child per age-category (6-12 months, 12-18 monhts, 18-24 months)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['motor development', 'baby', 'infant', 'motor milestones', 'crawling', 'independent walking'], 'conditions': ['Developmental Coordination Disorder', 'Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'This study compares motor development in three groups of infants (controls, DCD, DCD+ASD) before the age of 2 years using retrospective video analysis of infants in home video contexts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'CONTROLS:\n\nInclusion Criteria:\n\n* Availability of video material of the child before the age of 2.\n* No indication of DCD (as measured by M-ABC-2 Pc\\>16 and DCD-Q)\n* No indication of ASD (as measured by SRS-2 T-score ≤60 )\n\nExclusion Criteria:\n\n* Medical diagnosis possibly influencing motor development (DCD, ASD, ADHD, CP, ect)\n* Severe ilnesses in the early Developmental period (0-2y) which may have influenced the development (f.e. CVA, cancer, severe traumas,...)\n* Prolonged admission to the hospital (≥ 3 weeks) in the early Developmental period (0-2y)\n\nDCD GROUP:\n\nInclusion criteria:\n\n* Availability of video material of the child before the age of 2.\n* Formal diagnosis of DCD provided by multidisciplinary team in Flanders\n* Indication of DCD (as measured by M-ABC-2 Pc≤16 and DCD-Q)\n\nExclusion Criteria:\n\n* Other medical diagnosis possibly influencing motor development (ASD, ADHD, CP, ect)\n* Severe ilnesses in the early Developmental period (0-2y) which may have influenced the development (f.e. CVA, cancer, severe traumas,...)\n* Prolonged admission to the hospital (≥ 3 weeks) in the early Developmental period (0-2y)\n\nDCD+ASD GROUP:\n\nInclusion criteria:\n\n* Availability of video material of the child before the age of 2.\n* Formal diagnosis of DCD and ASD provided by multidisciplinary team in Flanders\n* Indication of DCD (as measured by M-ABC-2 Pc≤16 and DCD-Q)\n* Indication of ASD (as measured by SRS-2 T-score \\>60 )\n\nExclusion Criteria:\n\n* Other medical diagnosis possibly influencing motor development (ADHD, CP, ect.)\n* Severe ilnesses in the early Developmental period (0-2y) which may have influenced the development (f.e. CVA, cancer, severe traumas,...)\n* Prolonged admission to the hospital (≥ 3 weeks) in the early Developmental period (0-2y)'}, 'identificationModule': {'nctId': 'NCT04126395', 'acronym': 'RVA_DCD', 'briefTitle': 'An Explorative RVA of the Motor Development of Children With DCD <2y', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'An Explorative Retrospective Video-analysis of the Motor Development of Children With Developmental Coordination Disorder Before the Age of Two', 'orgStudyIdInfo': {'id': 'BC-05716'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Controls', 'description': 'This groups consists of children now aged 6-12y:\n\n* Without a medical diagnosis possibly influencing motor development\n* Without motor problems (M-ABC-2 and DCD-Q)\n* Without social reponsiveness problems (SRS-2)', 'interventionNames': ['Diagnostic Test: Movement Assessment Battery for Children 2(M-ABC-2)', 'Diagnostic Test: Developmental Coordination Disorder - Questionnaire (DCD-Q)', 'Diagnostic Test: Social Responsiveness Scale 2 (SRS-2)', 'Other: Retrospective Video Analysis']}, {'label': 'Developmental Coordination Disorder', 'description': 'This groups consists of children now aged 6-12y:\n\n* With a multidisciplinary diagnosis of DCD\n* With motor problems (M-ABC-2 and DCD-Q)', 'interventionNames': ['Diagnostic Test: Movement Assessment Battery for Children 2(M-ABC-2)', 'Diagnostic Test: Developmental Coordination Disorder - Questionnaire (DCD-Q)', 'Diagnostic Test: Social Responsiveness Scale 2 (SRS-2)', 'Other: Retrospective Video Analysis']}, {'label': 'Developmental Coordination Disorder + Autism Spectrum Disorder', 'description': 'This groups consists of children now aged 6-12y:\n\n* With a multidisciplinary diagnosis of DCD\n* With motor problems (M-ABC-2 and DCD-Q)\n* With social responsiveness problems (SRS-2)', 'interventionNames': ['Diagnostic Test: Movement Assessment Battery for Children 2(M-ABC-2)', 'Diagnostic Test: Developmental Coordination Disorder - Questionnaire (DCD-Q)', 'Diagnostic Test: Social Responsiveness Scale 2 (SRS-2)', 'Other: Retrospective Video Analysis']}], 'interventions': [{'name': 'Movement Assessment Battery for Children 2(M-ABC-2)', 'type': 'DIAGNOSTIC_TEST', 'description': 'The M-ABC-2 is a motor performance test for children aged 3 trough 16 years of age. We will use Dutch-Flemish norms.', 'armGroupLabels': ['Controls', 'Developmental Coordination Disorder', 'Developmental Coordination Disorder + Autism Spectrum Disorder']}, {'name': 'Developmental Coordination Disorder - Questionnaire (DCD-Q)', 'type': 'DIAGNOSTIC_TEST', 'description': 'The DCD-Q is a brief parent questionnaire designed to screen for the presence of DCD in children aged 5 trough 15 years of age. We will use Dutch norms.', 'armGroupLabels': ['Controls', 'Developmental Coordination Disorder', 'Developmental Coordination Disorder + Autism Spectrum Disorder']}, {'name': 'Social Responsiveness Scale 2 (SRS-2)', 'type': 'DIAGNOSTIC_TEST', 'description': 'The SRS-2 is a parent questionnaire designed to identify social impairments associated with ASD in children 4 trough 18 years of age. We will used Dutch norms.', 'armGroupLabels': ['Controls', 'Developmental Coordination Disorder', 'Developmental Coordination Disorder + Autism Spectrum Disorder']}, {'name': 'Retrospective Video Analysis', 'type': 'OTHER', 'description': 'Retrospective video analysis will be used to explore motor development in children with DCD, DCD+ASD and controls.', 'armGroupLabels': ['Controls', 'Developmental Coordination Disorder', 'Developmental Coordination Disorder + Autism Spectrum Disorder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Vancouver', 'country': 'Canada', 'facility': 'UBC', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Hilde Van Waelvelde, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}