Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-26 @ 4:05 PM
Study NCT ID:
NCT04344392
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2020-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening of Dysphagia Via Ultrasonography in Patients With Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006429', 'term': 'Hemiplegia'}], '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'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessor will be blinded to ultrasonographic measurements. Statistical analysis will be performed by an independent consultant.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-05', 'studyFirstSubmitDate': '2020-04-09', 'studyFirstSubmitQcDate': '2020-04-12', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glossopalatine junction opening and closing time', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Opening and closing time of glossopalatine junction after swallowing via videofluoroscopy in seconds.'}, {'measure': 'Velopharyngeal junction opening and closing time', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Opening and closing time of velopharyngeal junction after swallowing via videofluoroscopy in seconds.'}, {'measure': 'Laryngeal vestibule opening and closing time', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Opening and closing time of laryngeal vestibule after swallowing via videofluoroscopy in seconds.'}, {'measure': 'Upper esophageal sphincter opening and closing time', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Opening and closing time of upper esophageal sphincter after swallowing via videofluoroscopy in seconds.'}, {'measure': 'Hyoid horizontal replacement', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Maximal horizontal replacement of hyoid bone during swallowing via videofluoroscopy in centimeters.'}, {'measure': 'Hyoid vertical replacement', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Maximal vertical replacement of hyoid bone during swallowing via videofluoroscopy in centimeters.'}, {'measure': 'Thyroid-hyoid approximation', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Difference of distance between thyroid cartilage and hyoid bone in rest and swallowing in centimeters via ultrasonography.'}, {'measure': 'Tongue thickness', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Tongue thickness in cm assessed in rest submentally.'}, {'measure': 'Hyoid anterior replacement', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Distance of hyoid bone replacement between rest position and swallowing in centimeters via ultrasonography.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemiplegia', 'Dysphagia', 'Ultrasound', 'Videofluoroscopy'], 'conditions': ['Dysphagia, Oropharyngeal', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '19427098', 'type': 'BACKGROUND', 'citation': 'Huang YL, Hsieh SF, Chang YC, Chen HC, Wang TG. Ultrasonographic evaluation of hyoid-larynx approximation in dysphagic stroke patients. Ultrasound Med Biol. 2009 Jul;35(7):1103-8. doi: 10.1016/j.ultrasmedbio.2009.02.006. Epub 2009 May 7.'}, {'pmid': '22698507', 'type': 'BACKGROUND', 'citation': 'Hsiao MY, Chang YC, Chen WS, Chang HY, Wang TG. Application of ultrasonography in assessing oropharyngeal dysphagia in stroke patients. Ultrasound Med Biol. 2012 Sep;38(9):1522-8. doi: 10.1016/j.ultrasmedbio.2012.04.017. Epub 2012 Jun 12.'}, {'pmid': '16269630', 'type': 'BACKGROUND', 'citation': 'Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.'}]}, 'descriptionModule': {'briefSummary': 'Oropharyngeal dysphagia is commonly seen in patients with stroke. Clinical assessment may be used to evaluate dysphagia in patients with stroke however reliability of this method is controversial and videofluoroscopic study is still considered as gold standard. However, exposure to radiation, necessity for a experienced practitioner, an expensive device, and swallowing contrast agents are disadvantages of videofluoroscopy. Ultrasonography, on the other hand, is a cheap, noninvasive device which may demonstrate tongue and laryngeal movement dynamically. In this manner, this study aims to evaluate whether ultrasound can assess dysphagia in patients with hemiplegia accurately.', 'detailedDescription': "For a safe swallowing tongue muscles must function properly and larynx should replace superoanterior to close trachea via stretching cricopharyngeal muscle. In this context, approximation of thyroid cartilage and larynx is important for swallowing. These mechanisms are impaired in stroke, Parkinson's disease, traumatic brain injury, and neuromuscular disorders thus resulting oropharyngeal dysphagia. Clinical examination may be used for assessing dysphagia in those patients however reliability of this method is controversial and videofluoroscopic study is considered as gold standard for assessing dysphagia. Ultrasound is used to assess swallowing functions since 1970s however, the studies commonly focused on tongue thickness and functions. Due to advances in technology besides tongue thickness, ultrasonography may practically demonstrate how larynx and thyroid cartilage approximate and hor larynx moves anteriorly. In literature, three methods came to forefront as evaluation methods for dysphagia: 1) approximation of thyroid cartilage and hyoid bone (THA), 2) tongue thickness in rest (TT), and 3) hyoid bone anterior replacement (HAR). In previous studies, the efficiency of THA for assessing dysphagia via videofluoroscopic study has been demonstrated. However other methods have not been evaluated in dysphagic patients with stroke. Ultrasonography, as a cheap, portable and non-invasive method, is a promising for assessing dysphagia in patients with stroke. In this context, this study aims to test the reliability and efficacy of these three methods via ultrasound in dysphagic stroke patients and test the performance of ultrasound compared to videofluoroscopy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stroke diagnosis\n* aged 18-75\n* dysphagia assessed by bedside examination (phase 1: wet voice or cough after drinking 5 ml clear water is positive, phase 2: if phase 1 is negative, inability of drinking 60 ml of water in 2 minutes without coughing or wet voice is positive)\n\nExclusion Criteria:\n\n* unable to consent due cognitive dysfunction\n* unable to cooperate with videofluoroscopic study\n* dysphagia before stroke\n* rheumatologic or neuromuscular disorder that may cause dysphagia'}, 'identificationModule': {'nctId': 'NCT04344392', 'briefTitle': 'Screening of Dysphagia Via Ultrasonography in Patients With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Evaluation of Ultrasonography as a Screening Tool for Dysphagia in Patients With Stroke: Correlation With Videofluoroscopic Study', 'orgStudyIdInfo': {'id': '71306642-050.05.05.04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Dysphagic hemiplegic patients', 'description': 'Dysphagic patients with hemiplegia as assessed by clinical examination', 'interventionNames': ['Diagnostic Test: Ultrasonographic study', 'Diagnostic Test: Videofluoroscopic study temporal parameters', 'Diagnostic Test: Videofluoroscopic study distance parameters']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Volunteers which do not have an active swallowing dysfunction.', 'interventionNames': ['Diagnostic Test: Ultrasonographic study']}], 'interventions': [{'name': 'Ultrasonographic study', 'type': 'DIAGNOSTIC_TEST', 'description': 'Thyroid hyoid approximation and hyoid anterior replacement during swallowing. Tongue thickness in rest.', 'armGroupLabels': ['Control', 'Dysphagic hemiplegic patients']}, {'name': 'Videofluoroscopic study temporal parameters', 'type': 'DIAGNOSTIC_TEST', 'description': 'Glossopalatine junction opening and closing time, velopharyngeal junction opening and closing time, laryngeal vestibule opening and closing time, upper esophageal sphincter opening and closing time in seconds.', 'armGroupLabels': ['Dysphagic hemiplegic patients']}, {'name': 'Videofluoroscopic study distance parameters', 'type': 'DIAGNOSTIC_TEST', 'description': 'Hyoid bone horizontal and vertical replacement, thyroid-hyoid approximation (THA) in millimeters.', 'armGroupLabels': ['Dysphagic hemiplegic patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Ozan Volkan Yurdakul, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bezmialem University'}, {'name': 'Delal Öztürk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bezmialem University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}