Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT04761718
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2021-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Covid-19 Epidemic Lockdown Impact on Psychomotor Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-20', 'studyFirstSubmitDate': '2021-02-17', 'studyFirstSubmitQcDate': '2021-02-18', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pre lockdown assessment for physical activity', 'timeFrame': 'up to 24 weeks', 'description': 'Google form questionnaires include the physical activity questionnaire.'}, {'measure': 'post lockdown assessment for physical activity', 'timeFrame': 'up to 24 weeks', 'description': 'Google form questionnaires include the physical activity questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19 Epidemic Lockdown Impact']}, 'descriptionModule': {'briefSummary': 'PURPOSE:\n\nTo detect the Covid-19 Epidemic Lockdown impact on Psychomotor performance in Egyptian Children.\n\nBACKGROUND:\n\nThe corona virus disease (COVID-19) affected virtually all countries including Egypt as records showed 156,397 subjects including all age groups, Adolescents and children represent sector in the records, lockdown can contribute to widespread psychological distress and an increased risk of physical inactivity consequences shortly. Psychomotor disorders are expected during and aftermath of the pandemic. Validated Questionnaires are tools to assess the psychomotor condition during and after pandemic lockdown as safe and valid assessment tool.\n\nHYPOTHESES:\n\nCovid-19 Epidemic Lockdown has an impact on Psychomotor performance in Egyptian Children.\n\nRESEARCH QUESTION:\n\nDoes Covid-19 Epidemic Lockdown impact on Psychomotor performance in Egyptian Children?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be randomly selected from all provinces in Egypt.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n100 participants will be chosen according to the following criteria : subject in both sexes and their age will ranged between\n\n1. 6-9 years.\n2. 10-13 years.\n3. 14-18 years All subjects should be clinically and medically stable\n\nExclusion Criteria:\n\nSubjects with psychological or Motor impairment will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT04761718', 'briefTitle': 'Covid-19 Epidemic Lockdown Impact on Psychomotor Performance', 'organization': {'class': 'OTHER', 'fullName': 'Delta University for Science and Technology'}, 'officialTitle': 'Covid-19 Epidemic Lockdown Impact on Psychomotor Performance in Egyptian Children', 'orgStudyIdInfo': {'id': 'Covid-19 Epidemic impact'}}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'AAA', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '12 months after publishing', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Delta University for Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant. Professor of physical therapy, Department of Physical Therapy for Pediatrics', 'investigatorFullName': 'Amira Hussin Hussin Mohammed', 'investigatorAffiliation': 'Delta University for Science and Technology'}}}}