Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT05747859
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
2023-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Voice Telerehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014826', 'term': 'Vocal Cord Paralysis'}], 'ancestors': [{'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D020421', 'term': 'Vagus Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-04', 'studyFirstSubmitDate': '2023-02-15', 'studyFirstSubmitQcDate': '2023-02-17', 'lastUpdatePostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'analysis', 'timeFrame': '1 month', 'description': 'to analyze the functional outcomes achieved by a group of patients with recent onset of iatrogenic UVFP who were referred to TR using a synchronous approach.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vocal Fold Palsy']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to determine functional results of telerehabilitation (TR) in subjects affected by iatrogenic unilateral vocal fold paralysis (UVFP) during the COVID-19 pandemic outbreak. 40 patients with iatrogenic unilateral vocal fold paralysis underwent voice teletherapy with a synchronous approach. A multidimensional assessment by means of videolaryngostroboscopy, acoustic and perceptual analysis and patient self-assessment was carried out before, at the end of teletherapy and six months later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '15 subjects affected by permanent iatrogenic UVFP', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18-75 years\n* onset of UVFP less than 1 month before\n* internet access\n* availability and ability to use a computer with an internal or external webcam.\n\nExclusion Criteria:\n\n* previous history of laryngeal pulmonary or gastric surgery\n* current or previous pulmonary diseases\n* hearing loss, neurological or motor deficits\n* reading difficulties\n* dysphagia\n* unavailability of a computer and a webcam.'}, 'identificationModule': {'nctId': 'NCT05747859', 'briefTitle': 'Voice Telerehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Voice Telerehabilitation for Patients Affected by Iatrogenic Unilateral Vocal Fold Paralysis: From Necessity to Opportunity in the COVID-19 Time', 'orgStudyIdInfo': {'id': '4427'}}, 'armsInterventionsModule': {'interventions': [{'name': 'teletherapy', 'type': 'OTHER', 'description': 'speech therapy remotely delivered'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario A. Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Giorgia Mari, SLP MSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, Rome'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'mari Giorgia', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}