Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-02-20 @ 10:50 PM
Study NCT ID:
NCT04696133
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2021-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensory Integration Versus Fine Motor Intervention in Children With Autism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2021-01-03', 'studyFirstSubmitQcDate': '2021-01-04', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gilliam autism rating scale', 'timeFrame': '3 months', 'description': 'higher the autism index, indicate the probability the individual has autism'}], 'secondaryOutcomes': [{'measure': 'Bruininks-Oseretsky Test Of Motor Proficiency', 'timeFrame': '3 months', 'description': "Fine manual control domain will be assessed in the current study. Gender specific norms were used for scoring as the scale's authors report these as being more accurate than combined gender norms"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autism Spectrum Disorder', 'Quality of life', 'sensory integration', 'fine motor skills'], 'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'Clinically, infants with Autism spectrum often display gross motor delays in supine, prone, and sitting skills in their first year of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ranges from 8 to 12 years.\n* Mild to moderate autistic features\n\nExclusion Criteria:\n\n• Significant visual or auditory defects.'}, 'identificationModule': {'nctId': 'NCT04696133', 'briefTitle': 'Sensory Integration Versus Fine Motor Intervention in Children With Autism', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Therapeutic Outcomes of Sensory Integration Versus Fine Motor Intervention on Autistic Features and Fine Motor Skills in Children With Autism: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Autism spectrum'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'conventional training', 'description': 'children received fine motor exercises', 'interventionNames': ['Other: fine motor skills']}, {'type': 'EXPERIMENTAL', 'label': 'sensory integration training', 'description': 'Children received designed sensory integration program', 'interventionNames': ['Other: sensory integration']}], 'interventions': [{'name': 'fine motor skills', 'type': 'OTHER', 'description': 'stretching and strengthening exercises in addition to exercises to enhance fine motor skills', 'armGroupLabels': ['conventional training']}, {'name': 'sensory integration', 'type': 'OTHER', 'description': '* Tactile stimulation\n* Proprioceptive stimulation', 'armGroupLabels': ['sensory integration training']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'faculty of physical therapy, Cairo university', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Emam H El-Negamy, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}, {'name': 'kamilia saad', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'dalia galal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo university, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Amira Abd-elmonem, assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university', 'investigatorFullName': 'Amira Mahmoud Abd-elmonem', 'investigatorAffiliation': 'Cairo University'}}}}