Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2026-02-22 @ 1:44 AM
Study NCT ID:
NCT04639427
Status:
UNKNOWN
Last Update Posted:
2021-07-14
First Post:
2020-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benefits of Using a Transparent Visor to Replace the Face Mask in Speech Therapy Rehabilitation of Oral-Linguo-Facial Praxies in the Context of COVID-19: a Series of Cases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-12', 'studyFirstSubmitDate': '2020-11-19', 'studyFirstSubmitQcDate': '2020-11-19', 'lastUpdatePostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral-Linguo-Facial Motricity Test', 'timeFrame': 'throughtout of the study, an average of 2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral-Linguo-Facial praxies', 'Covid19', 'speech therapy rehabilitation'], 'conditions': ['Oral-Linguo-Facial Praxies', 'Covid19']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to compare the effectiveness of the use of a transparent covering visor with that of the face mask, with or without the use of video sequences, for speech therapy rehabilitation of oral-linguo-facial praxies in the context of the COVID 19 epidemic.', 'detailedDescription': 'Statistic analysis: single case experimental design (SCED) method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '4 patients hospitalized in the adult neurological Post Intensive Care Rehabilitation Unit (PICRU - SRPR) of Raymond Poincaré hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged \\>= 18 years;\n* Hospitalization for more than 2 weeks prior to enrollment in the adult post intensive care rehabilitation care unit (PICRU) of Raymond Poincaré hospital in Garches;\n* With oral-linguo-facial praxis disorders whatever the cause;\n* Has been informed and not in opposition to participation of the study.\n\nExclusion Criteria:\n\n* Patient with fever or any suspect symptom of a SARS-CoV2 infection;\n* Planned discharge of hospital in 2 weeks;\n* Patient with cognitive, phasic or vigilance disorders preventing to understand the study;\n* Under guardianship or curator;\n* Patient Under french AME scheme.'}, 'identificationModule': {'nctId': 'NCT04639427', 'acronym': 'Co-VIS', 'briefTitle': 'Benefits of Using a Transparent Visor to Replace the Face Mask in Speech Therapy Rehabilitation of Oral-Linguo-Facial Praxies in the Context of COVID-19: a Series of Cases', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Benefits of Using a Transparent Visor to Replace the Face Mask in Speech Therapy Rehabilitation of Oral-Linguo-Facial Praxies in the Context of COVID-19: a Series of Cases', 'orgStudyIdInfo': {'id': 'APHP200876'}, 'secondaryIdInfos': [{'id': 'IDRCB', 'type': 'REGISTRY', 'domain': '2020-A01628-31'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Unité de Soins de Rééducation Post Réanimation, Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'centralContacts': [{'name': 'Julie PAQUEREAU, MD', 'role': 'CONTACT', 'email': 'julie.paquereau@aphp.fr', 'phone': '+ 33 (0)1 47 10 79 00'}], 'overallOfficials': [{'name': 'Julie PAQUEREAU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unité de Soins de Rééducation Post Réanimation, Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}