[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05603897":3,"trial-entities:NCT05603897":99,"trial-summary:NCT05603897":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":48,"std_ages":61,"locations":64,"central_contacts":89,"overall_officials":95,"references":97,"see_also_links":98},"NCT05603897","20220558","Non-standardized vs. Standardized Screening for Dysphagia","Utility of Non-standardized Clinical Swallow Evaluation vs. Standardized Swallow Evaluation to Identify the Presence of Dysphagia and Risk for Aspiration in Patients Post-ischemic Stroke in Acute Inpatient Rehabilitation","RECRUITING","2026-11-30","2025-09","2026-04-29","2024-04-05","University of Miami","OTHER",false,"The purpose of this study is to compare two different screening tests for detecting dysphagia (difficulty swallowing) as well as the risk for aspiration (silent swallowing of liquids\u002Fsolids into the lungs) in patients after an ischemic stroke (when a blood clot blocks or narrows an artery leading to the brain).",null,[19],"Dysphagia",[21],"difficulty swallowing","INTERVENTIONAL","SCREENING",[25],"NA",{"count":27,"type":28},50,"ESTIMATED",[30,35],{"type":14,"name":31,"description":32,"armGroupLabels":33},"Mann Assessment of Swallowing Ability (MASA) (dysphagia screening tool)","Upon 1-2 days of admission to inpatient rehabilitation, the MASA will be administered for approximately 20 minutes during initial speech language pathology evaluation. The MASA will be administered at bedside as a cognitive\u002Fspeech language evaluation as well as oropharyngeal function examination.",[34],"Mann Assessment of Swallowing Ability (MASA) Group",{"type":14,"name":36,"description":37,"armGroupLabels":38},"Non-standardized clinical swallow evaluation","Participants will receive current standard of care for dysphagia screening and treatment.",[39],"Non-standardized clinical swallow evaluation Group",[41],{"measure":42,"description":43,"timeFrame":44},"Dysphagia measured by MASA","The MASA is a 24-item clinical test that evaluates swallowing in the order in which swallowing phases occur. Each item is quantitatively scored using either a 5-point or 10-point score at the end of which a total score out of 200 is summed up. The MASA takes approximately 15-20 minutes to perform and can then be repeated during a patient's clinical course to monitor for recovery.","Up to 20 minutes",[],"ALL","18 Years",{"inclusion":49,"exclusion":54,"raw_text":60},[50,51,52,53],"Adults ≥ 18 years old","Patients admitted to Lynn Rehabilitation Center with an admitting diagnosis consistent with acute ischemic stroke within the past 1 month","Patients able to provide informed, written consent. If patients are not cognitively able to give informed consent, then consent will be obtained from patient proxy in person or over the phone","Able to read and comprehend verbal instruction in English and\u002For Spanish",[55,56,57,58,59],"Adults \\> 80 years old","Pregnant women","Prisoners","Those with a prior history of dysphagia","Those with any diagnoses that include acute intracranial hemorrhage, subdural hematoma, subarachnoid hemorrhage, traumatic brain injury","Inclusion Criteria:\n\n* Adults ≥ 18 years old\n* Patients admitted to Lynn Rehabilitation Center with an admitting diagnosis consistent with acute ischemic stroke within the past 1 month\n* Patients able to provide informed, written consent. If patients are not cognitively able to give informed consent, then consent will be obtained from patient proxy in person or over the phone\n* Able to read and comprehend verbal instruction in English and\u002For Spanish\n\nExclusion Criteria:\n\n* Adults \\> 80 years old\n* Pregnant women\n* Prisoners\n* Those with a prior history of dysphagia\n* Those with any diagnoses that include acute intracranial hemorrhage, subdural hematoma, subarachnoid hemorrhage, traumatic brain injury",[62,63],"ADULT","OLDER_ADULT",[65],{"facility":66,"status":8,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":86},"Lynn Rehabilitation Center \u002F University of Miami","Miami","Florida","33136","United States",[72,77,81,83],{"name":73,"role":74,"phone":75,"email":76},"Gemayaret Alvarez, MD","CONTACT","305-243-6605","g.alvarez3@miami.edu",{"name":78,"role":74,"phone":79,"email":80},"Claudia Santesteban-bidot, MS","305-585-9449","claudia.santesteban@jhsmiami.org",{"name":73,"role":82},"PRINCIPAL_INVESTIGATOR",{"name":84,"role":85},"Sarah Kurtevski, MD","SUB_INVESTIGATOR",{"lat":87,"lon":88},25.77427,-80.19366,[90,93],{"name":73,"role":74,"phone":91,"email":92},"305-585-9420","g.alvarez3@med.miami.edu",{"name":94,"role":74,"phone":79,"email":80},"Claudia Santesteban-bidot, M.S.",[96],{"name":73,"affiliation":13,"role":82},[],[],{"nct_id":4,"conditions":100,"biomarkers":102},[19,101],"Ischemic Stroke",[],{"nct_id":4,"found":104,"summary":105,"prompt_version":115},true,{"design":106,"status":107,"heading":108,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This interventional study aims to enroll 50 participants. It compares two different screening methods for dysphagia.","completed","Comparing Dysphagia Screening Tests After Stroke","This study is comparing two ways to screen for dysphagia (difficulty swallowing) and the risk of aspiration (when food or liquid goes down the wrong pipe into the lungs) in adults who have recently had an ischemic stroke (a stroke caused by a blood clot). Researchers are comparing the Mann Assessment of Swallowing Ability (MASA) with the usual non-standardized clinical swallow evaluation. The goal is to see which method is better at identifying dysphagia. You might be able to join if you are an adult, at least 18 years old, and have been admitted to Lynn Rehabilitation Center within the last month for an acute ischemic stroke. The study plans to enroll 50 participants.","Your dysphagia will be measured by MASA for up to 20 minutes after the assessment.",114,"If you participate, you would receive the Mann Assessment of Swallowing Ability (MASA) during your initial speech-language pathology evaluation, which takes about 20 minutes. You would also receive the current standard of care for dysphagia screening and treatment.","Not stated in the trial record.",[36],"v2"]