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Development of Dysphagia Protocol in Ankara City Hospital Stroke Patients

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ClinicalTrials.gov Identifier: NCT04739514
Recruitment Status : Not yet recruiting
First Posted : February 4, 2021
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Nazife Kapan, Ankara City Hospital Bilkent

Study Description
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Brief Summary:
Stroke, also called cerebrovascular disease, is a sudden-onset neurological disorder that causes a regional or general dysfunction in the brain due to vascular causes. Dysphagia, one of the common complications of stroke, is associated with increased morbidity and mortality.The aim of this study is to evaluate the clinical evaluation of swallowing in stroke patients and to determine the factors affecting the severity and prognosis of dysphagia in patients with dysphagia.Fifty-five patients with acute stroke and dysphagia who were admitted to Ankara City Hospital Neurology Clinic and diagnosed with stroke by neurology and who did not meet the exclusion criteria will be included in this study. When the patients are admitted to the neurology clinic and will be discharged, they will be evaluated three times, in the first month after discharge.

Condition or disease Intervention/treatment Phase
Stroke, Acute Other: Exercises for dysphagia rehabilitation Not Applicable

Detailed Description:
Stroke, also called cerebrovascular disease, is a sudden-onset neurological disorder that causes a regional or general dysfunction in the brain due to vascular causes. Dysphagia, one of the common complications of stroke, is associated with increased morbidity and mortality.The aim of this study is to evaluate the clinical evaluation of swallowing in stroke patients and to determine the factors affecting the severity and prognosis of dysphagia in patients with dysphagia.Fifty-five patients with acute stroke and dysphagia who were admitted to Ankara City Hospital Neurology Clinic and diagnosed with stroke by neurology and who did not meet the exclusion criteria will be included in this study. When the patients are admitted to the neurology clinic and will be discharged, they will be evaluated three times, in the first month after discharge. Clinical evaluations will be made by the responsible investigator in the examination room. Patients will be evaluated with a bedside swallowing screening test. Patients will be divided into 3 groups as mild, moderate and severe dysphagia according to the test. The patients will be evaluated while they are in the neurology clinic and 1 month after the treatment is given.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of Dysphagia Protocol in Ankara City Hospital Stroke Patients
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Mild dysphagia Other: Exercises for dysphagia rehabilitation
Diet modifications, postural exercises, compensatory exercises, swallowing exercises
Active Comparator: Moderate dysphagia Other: Exercises for dysphagia rehabilitation
Diet modifications, postural exercises, compensatory exercises, swallowing exercises
Active Comparator: Severe dysphagia Other: Exercises for dysphagia rehabilitation
Diet modifications, postural exercises, compensatory exercises, swallowing exercises


Outcome Measures
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Primary Outcome Measures :
  1. Gugging swallowing screening test [ Time Frame: Change from Baseline Gugging swallowing screening test at 1 months ]
    The gugging test is a validated test in the assessment of bedside swallowing. This test was defined as 20 points (no dysphagia), 15-19 (mild dysphagia), 10-14 (moderate dysphagia) and 9 points or less (severe dysphagia).

  2. Eating assessment tool-10 [ Time Frame: Change from Baseline Gugging swallowing screening test at 1 months ]
    The eating assessment tool-10 is a test that evaluates dysphagia symptoms and severity without any food intake. This test is a test consisting of 10 questions in total and scoring the questions between "no problem" and "serious problem". As the score increases, the severity of dysphagia increases.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with acute stroke by neurology
  • Having trouble swallowing
  • 18-85 years old, volunteers

Exclusion Criteria:

  • Unconscious
  • Uncooperative
  • Those with oropharyngeal structural damage
  • Patients with malignancies involving the head and neck region
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04739514


Contacts
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Contact: Nazife K Kapan, Dr. 03125526000 nazifekapan@gmail.com
Contact: Müyesser A Aras, Prof. Dr. 03125526000 drmuyesser@hotmail.com

Locations
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Turkey
Ankara Şehir Hastanesi
Ankara, Turkey
Contact: Nazife Kapan, Dr.    03125526000    nazifekapan@gmail.com   
Contact: Müyesser Aras, Prof. Dr.    03125526000    drmuyesser@hotmail.com   
Principal Investigator: Nazife Kapan, Dr.         
Sub-Investigator: Müyesser Aras, Prof. Dr.         
Sub-Investigator: Evren Yaşar, Prof. Dr.         
Sub-Investigator: Emre Adıgüzel, Assoc.Prof.         
Sub-Investigator: Mariam Kavakcı, Dkt.         
Sub-Investigator: Melike Tanrıverdi, Dkt.         
Sub-Investigator: Hesna Bektaş, Assoc.Prof.         
Sponsors and Collaborators
Nazife Kapan
More Information
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Publications of Results:
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. Review. Erratum in: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.

Other Publications:

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Responsible Party: Nazife Kapan, principal investigator, Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier: NCT04739514    
Other Study ID Numbers: AŞH-NK-TEZ
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases