Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-27 @ 10:29 PM
Study NCT ID:
NCT06558435
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2024-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of BRACS to European Portuguese
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005249', 'term': 'Fees and Charges'}], 'ancestors': [{'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2024-08-14', 'studyFirstSubmitQcDate': '2024-08-14', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliable and validated European Portuguese version of the BRACS', 'timeFrame': 'patients with neurological and/or mechanical oropharyngeal dysphagia evaluated FEES up to 3 months after the first symptomatology', 'description': "Demonstrating the reliability and validity of the Boston Residue and Clearance Scale in diagnosing dysphagia during fiberoptic endoscopic assessment of swallowing examination. BRACS it's an 11-point ordinal residue classification scale that assesses 3 aspects: the amount and location of pharyngolaryngeal residues, the presence of spontaneous swallowing to clear it and the effectiveness of patient's swallowing."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Swallowing Disorders', 'Dysphagia', 'Fiberoptic Endoscopic Evaluation of Swallowing'], 'conditions': ['Deglutition Disorders', 'Swallowing Disorder', 'Dysphagia, Oropharyngeal']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to translate and validate the fiberoptic endoscopic evaluation of swallowing scale "The Boston Residue and Clearance Scale - BRACS" to European Portuguese', 'detailedDescription': "The Boston Residue and Clearance Scale (BRACS) is a multidimensional scale developed and validated to assess the severity of residues observed during fiberoptic endoscopic evaluation of swallowing (FEES).\n\nIt differs from other FEES residue scales, since it considers all aspects related to pharyngolaryngeal residues, specifically, the location, amount and the patient's clearance ability.\n\nThe purpose of this study was to translate and cross-culturally adapt the English version of the BRACS into European Portuguese and to investigate the reliability and validity of the translated version of the scale."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with neurological or mechanical dysphagia who have undergone a FEES examination and whose test meets the inclusion criteria described above.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* FEES recording that allowed good visualisation of the pharynx and larynx.\n* FEES recording of patients after head and neck surgery who had anatomical alterations of the structures, but which did not interfere with good visualisation of the residues.\n* FEES recording of patients with a tracheostomy or under tube feeding.\n\nExclusion Criteria:\n\n* FEES recording of patients under 18 years of age.'}, 'identificationModule': {'nctId': 'NCT06558435', 'briefTitle': 'Validation of BRACS to European Portuguese', 'organization': {'class': 'OTHER', 'fullName': 'Centro Hospitalar de Entre o Douro e Vouga'}, 'officialTitle': 'Translation and Validation of "The Boston Residue and Clearance Scale" to European Portuguese', 'orgStudyIdInfo': {'id': '252023'}}, 'armsInterventionsModule': {'interventions': [{'name': 'FEES', 'type': 'OTHER', 'otherNames': ['Fiberoptic Endoscopic Evaluation of Swallowing'], 'description': 'Single group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4520-211', 'city': 'Santa Maria da Feira', 'country': 'Portugal', 'facility': 'Centro Hospitalar de Entre Douro e Vouga', 'geoPoint': {'lat': 40.92726, 'lon': -8.54839}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Hospitalar de Entre o Douro e Vouga', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Speech and Language Pathologist Daniela Ferreira', 'investigatorFullName': 'Daniela Ferreira', 'investigatorAffiliation': 'Centro Hospitalar de Entre o Douro e Vouga'}}}}