Development of Dysphagia Protocol in Ankara City Hospital Stroke Patients

Stroke, Acute Clinical Trial

Official title:

Development of Dysphagia Protocol in Ankara City Hospital Stroke Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04739514
• Other study ID #: ASH-NK-TEZ
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: February 2021
• Source: Ankara City Hospital Bilkent
• Contact: Nazife K Kapan, Dr.
• Phone: 03125526000
• Email: nazifekapan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. completion date: June 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Other:
• Exercises for dysphagia rehabilitation
Diet modifications, postural exercises, compensatory exercises, swallowing exercises

Locations

Country	Name	City	State
Turkey	Ankara Sehir Hastanesi	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Nazife Kapan

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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, Muss — View Citation

Broadley S, Cheek A, Salonikis S, Whitham E, Chong V, Cardone D, Alexander B, Taylor J, Thompson P. Predicting prolonged dysphagia in acute stroke: the Royal Adelaide Prognostic Index for Dysphagic Stroke (RAPIDS). Dysphagia. 2005 Fall;20(4):303-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gugging swallowing screening test	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).	Change from Baseline Gugging swallowing screening test at 1 months
Primary	Eating assessment tool-10	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.	Change from Baseline Gugging swallowing screening test at 1 months