Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-30 @ 4:03 AM
Study NCT ID:
NCT04395833
Status:
COMPLETED
Last Update Posted:
2020-05-20
First Post:
2020-05-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National Survey on the Lockdown of Children With Disabilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-15', 'studyFirstSubmitDate': '2020-05-15', 'studyFirstSubmitQcDate': '2020-05-15', 'lastUpdatePostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Experience during lockdown', 'timeFrame': 'From the 6th of April 2020 until the 11th of May 2020', 'description': 'Identify the lived experience, the needs, and difficulties of children with motor disabilities and their parents during the COVID-2019 lockdown'}, {'measure': 'Health risk during lockdown', 'timeFrame': 'From the 6th of April 2020 until the 11th of May 2020', 'description': 'Identify the risks on health of children with motor disabilities due to the COVID-2019 lockdown'}, {'measure': 'Impact on medical and rehabilitation follow up', 'timeFrame': 'From the 6th of April 2020 until the 11th of May 2020', 'description': 'Identify the impact on the medical and rehabilitation follow up of children with disabilities during COVID-19 lockdown'}, {'measure': 'Impact on daily living', 'timeFrame': 'From the 6th of April 2020 until the 11th of May 2020', 'description': 'Identify the impact on the daily living of children with motor disabilities and their families during the COVID-19 lockdown'}], 'secondaryOutcomes': [{'measure': 'Experience during lockdown', 'timeFrame': 'From the 24th of April 2020 until the 11th of May 2020', 'description': 'Identify the lived experience, the needs, and difficulties of children without motor disabilities and their parents during the COVID-2019 lockdown'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Identify Emerging Health Challenges for Children With Motor Disabilities and Their Parents Facing the COVID-19 Pandemic']}, 'descriptionModule': {'briefSummary': 'During the COVID-19 pandemic, lockdown measures were established in France affecting the life course of children with disabilities. This study aimed at identifying the experiences, main difficulties and needs of these children and their parents during the lockdown period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with motor disabilities, with and without associated impairement', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-children (age 0-18 years) with motor disabilities (with and without associated impairement), living in France.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04395833', 'acronym': 'ECHO', 'briefTitle': 'National Survey on the Lockdown of Children With Disabilities', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Emerging Health Challenges for Children With Motor Disabilities and Their Parents Facing the COVID-19 Pandemic: Messages From Families Answering the ECHO French National Survey', 'orgStudyIdInfo': {'id': 'CHRU de BREST ECHO'}}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}