Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-29 @ 9:17 PM
Study NCT ID:
NCT00903669
Status:
COMPLETED
Last Update Posted:
2009-05-18
First Post:
2009-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anthropometric Angular Measurement to Determine Muscle Tonus in Patients With Peripheral Facial Paralysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2009-10-16', 'releaseDate': '2009-09-15'}, {'resetDate': '2010-01-22', 'releaseDate': '2009-12-16'}, {'resetDate': '2010-06-08', 'releaseDate': '2010-05-15'}, {'resetDate': '2010-07-09', 'releaseDate': '2010-06-13'}, {'resetDate': '2010-08-19', 'releaseDate': '2010-07-22'}, {'resetDate': '2010-11-12', 'releaseDate': '2010-10-18'}, {'resetDate': '2011-01-24', 'releaseDate': '2011-01-06'}, {'resetDate': '2011-02-25', 'releaseDate': '2011-01-25'}, {'resetDate': '2011-03-31', 'releaseDate': '2011-03-02'}, {'resetDate': '2011-05-17', 'releaseDate': '2011-04-24'}], 'estimatedResultsFirstSubmitDate': '2009-09-15'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005158', 'term': 'Facial Paralysis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-14', 'studyFirstSubmitDate': '2009-05-14', 'studyFirstSubmitQcDate': '2009-05-14', 'lastUpdatePostDateStruct': {'date': '2009-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Facial paralysis', 'Muscle tonus', 'Rehabilitation', 'Myofunctional', 'Stomatognathic system'], 'conditions': ['Peripheral Facial Paralysis']}, 'descriptionModule': {'briefSummary': 'The current study sought to determine the reliability of the rehabilitation protocol using the labial commissure angle (LCA) as an indicator of both muscle tonus and therapeutic success. The investigators hypothesized that this measurement would provide objective data regarding the efficacy of rehabilitation for these challenging patients.', 'detailedDescription': 'CONTEXT AND OBJECTIVE: In cases of peripheral facial paralysis (PFP), diminished facial movements and their resultant cosmetic sequelae may have significant emotional repercussions, in addition to producing pronounced functional deficits. Abnormal muscle proprioception and deviation of the nasal-labial filter may also interfere with articulation of the labiodental and bilabial phonemes, thus diminishing speech intelligibility. In relation to stomatognathic functions, weakened labial occlusion decreases intraoral pressure, thereby hindering liquid retention in the buccal cavity and giving rise to vestibular stasis on the paralyzed side. The aim of this study was to evaluate the reliability of the labial commissure angle (LCA) as an anthropometric marker for objectively assessing changes in facial muscle tonus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with PFP treated in the Hospital of Unicamp', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age range between 20 and 70 years\n* incomplete PFP (Degree IV)\n* integral facial nerve (FN)\n\nExclusion Criteria:\n\n* systemic disease\n* potentially aggravating the PFP (neurological, degenerative, endocrinological)'}, 'identificationModule': {'nctId': 'NCT00903669', 'acronym': 'PF', 'briefTitle': 'Anthropometric Angular Measurement to Determine Muscle Tonus in Patients With Peripheral Facial Paralysis', 'organization': {'class': 'OTHER', 'fullName': 'University of Campinas, Brazil'}, 'officialTitle': 'Anthropometric Angular Measurement to Determine Muscle Tonus in Patients With Peripheral Facial Paralysis', 'orgStudyIdInfo': {'id': 'ATessitore'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Peripheral Facial Paralysis (PFP)', 'description': 'Patients who are diagnosed with peripheral facial paralysis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13081-970', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade estadual de Campinas', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}], 'overallOfficials': [{'name': 'Jorge R Paschoal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Estadual de Campinas, Unicamp'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campinas, Brazil', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jorge Rizzato Paschoal', 'oldOrganization': 'Department of Otolaryngology School of Medical Sciences - UNICAMP'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2009-09-15', 'type': 'RELEASE'}, {'date': '2009-10-16', 'type': 'RESET'}, {'date': '2009-12-16', 'type': 'RELEASE'}, {'date': '2010-01-22', 'type': 'RESET'}, {'date': '2010-05-15', 'type': 'RELEASE'}, {'date': '2010-06-08', 'type': 'RESET'}, {'date': '2010-06-13', 'type': 'RELEASE'}, {'date': '2010-07-09', 'type': 'RESET'}, {'date': '2010-07-22', 'type': 'RELEASE'}, {'date': '2010-08-19', 'type': 'RESET'}, {'date': '2010-10-18', 'type': 'RELEASE'}, {'date': '2010-11-12', 'type': 'RESET'}, {'date': '2011-01-06', 'type': 'RELEASE'}, {'date': '2011-01-24', 'type': 'RESET'}, {'date': '2011-01-25', 'type': 'RELEASE'}, {'date': '2011-02-25', 'type': 'RESET'}, {'date': '2011-03-02', 'type': 'RELEASE'}, {'date': '2011-03-31', 'type': 'RESET'}, {'date': '2011-04-24', 'type': 'RELEASE'}, {'date': '2011-05-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Department of Otolaryngology School of Medical Sciences - UNICAMP (Jorge Rizzato Paschoal)'}}}}