Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-30 @ 12:09 PM
Study NCT ID:
NCT06889233
Status:
COMPLETED
Last Update Posted:
2025-03-21
First Post:
2025-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MOTOR PROFICIENCY IN RELATION TO COGNITIVE FUNCTIONS AND SEVERITY IN CHILDREN WITH AUTISM SPECTRUM DISORDERS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-16', 'studyFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2025-03-16', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'measuring severity of autism by using CARS scale', 'timeFrame': '12 weeks', 'description': 'this scale like questionnaire consisted of 15 question and parents or teacher give answers to this questions'}], 'primaryOutcomes': [{'measure': 'measuring motor proficiency (gross & fine motor skills ) by using BOT2 scale', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'measuring cognitive functions by RAVEN Progressive matrices', 'timeFrame': '12 weeks', 'description': 'this scale items like puzzle and the child must extract the missed part from six choices'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AUTISM', 'ASD', 'RAVEN', 'CARS', 'BOT2', 'FINE MOTOR SKILLS', 'Gross motor skills'], 'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'To investigate the relationship between cognitive function, the severity of autism spectrum disorder (ASD), and the development of fine and gross motor skills in children with ASD', 'detailedDescription': "A sample of 64 children with autism aged from 5 to 12 years recruited from centres and schools of special needs for intellectual and developmental disabilities to measure cognitive function using the Raven's Progressive Matrices and measure the severity of autism using the Childhood Autism Rating Scale (CARS). These assessments will then be compared with the children's fine and gross motor abilities"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'autistic children age ranged from 5 to 12 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Children had been diagnosed with ASD.\n2. Their chronological age ranged from 5 years to 12 years.\n3. Intelligence quotient (IQ) ranged from 55 to 85.\n\nExclusion criteria:\n\nAny child with the following criteria would be directly excluded from the evaluation for the consistency of the sample and statistically obtained results:\n\n1. The child with ASD and other motor disabilities.\n2. Visual or hearing impairment.'}, 'identificationModule': {'nctId': 'NCT06889233', 'briefTitle': 'MOTOR PROFICIENCY IN RELATION TO COGNITIVE FUNCTIONS AND SEVERITY IN CHILDREN WITH AUTISM SPECTRUM DISORDERS', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'MOTOR PROFICIENCY IN RELATION TO COGNITIVE FUNCTIONS AND SEVERITY IN CHILDREN WITH AUTISM SPECTRUM DISORDERS', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005056'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'observational group', 'description': "We will assess cognitive function using the Raven's Progressive Matrices and measure the severity of autism using the Childhood Autism Rating Scale (CARS). These assessments will then be compared with the children's fine and gross motor abilities using BOT2 .", 'interventionNames': ['Behavioral: measuring cognitive functions, severity of autism , gross and fine motor skills']}], 'interventions': [{'name': 'measuring cognitive functions, severity of autism , gross and fine motor skills', 'type': 'BEHAVIORAL', 'description': 'measuring cognitive functions by RAVEN measuring severity by CARS measuring fine and gross motor functions by BOT2', 'armGroupLabels': ['observational group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Cairo', 'state': 'Dokki', 'country': 'Egypt', 'facility': 'Faculty of physical therapy cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Heba Kamal professor, professor of physical therapy', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}, {'name': 'Alaa fahmy hassan El Nemer, lecturer of physical therapy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'senior physiotherapist', 'investigatorFullName': 'Aya Gamal Ali Abdelmoniem', 'investigatorAffiliation': 'Cairo University'}}}}