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Development of Dysphagia Protocol in Ankara City Hospital Stroke Patients

Primary Purpose

Stroke, Acute

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercises for dysphagia rehabilitation
Sponsored by
Nazife Kapan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ankara Şehir Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Mild dysphagia

Moderate dysphagia

Severe dysphagia

Arm Description

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2021
Last Updated
February 3, 2021
Sponsor
Nazife Kapan
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1. Study Identification

Unique Protocol Identification Number
NCT04739514
Brief Title
Development of Dysphagia Protocol in Ankara City Hospital Stroke Patients
Official Title
Development of Dysphagia Protocol in Ankara City Hospital Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Anticipated)
Primary Completion Date
May 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nazife Kapan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mild dysphagia
Arm Type
Active Comparator
Arm Title
Moderate dysphagia
Arm Type
Active Comparator
Arm Title
Severe dysphagia
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Exercises for dysphagia rehabilitation
Intervention Description
Diet modifications, postural exercises, compensatory exercises, swallowing exercises
Primary Outcome Measure Information:
Title
Gugging swallowing screening test
Description
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).
Time Frame
Change from Baseline Gugging swallowing screening test at 1 months
Title
Eating assessment tool-10
Description
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.
Time Frame
Change from Baseline Gugging swallowing screening test at 1 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nazife K Kapan, Dr.
Phone
03125526000
Email
nazifekapan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Müyesser A Aras, Prof. Dr.
Phone
03125526000
Email
drmuyesser@hotmail.com
Facility Information:
Facility Name
Ankara Şehir Hastanesi
City
Ankara
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nazife Kapan, Dr.
Phone
03125526000
Email
nazifekapan@gmail.com
First Name & Middle Initial & Last Name & Degree
Müyesser Aras, Prof. Dr.
Phone
03125526000
Email
drmuyesser@hotmail.com
First Name & Middle Initial & Last Name & Degree
Nazife Kapan, Dr.
First Name & Middle Initial & Last Name & Degree
Müyesser Aras, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Evren Yaşar, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Emre Adıgüzel, Assoc.Prof.
First Name & Middle Initial & Last Name & Degree
Mariam Kavakcı, Dkt.
First Name & Middle Initial & Last Name & Degree
Melike Tanrıverdi, Dkt.
First Name & Middle Initial & Last Name & Degree
Hesna Bektaş, Assoc.Prof.

12. IPD Sharing Statement

Citations:
PubMed Identifier
16633876
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. doi: 10.1007/s00455-005-0032-y.
Results Reference
background
PubMed Identifier
28122885
Citation
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez 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. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.
Results Reference
result

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Development of Dysphagia Protocol in Ankara City Hospital Stroke Patients

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