NCT04739514

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

February 1, 2021

Last Update Submit

February 3, 2021

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (3)

Mild dysphagia

ACTIVE COMPARATOR
Other: Exercises for dysphagia rehabilitation

Moderate dysphagia

ACTIVE COMPARATOR
Other: Exercises for dysphagia rehabilitation

Severe dysphagia

ACTIVE COMPARATOR
Other: Exercises for dysphagia rehabilitation

Interventions

Exercises for dysphagia rehabilitationOTHER

Diet modifications, postural exercises, compensatory exercises, swallowing exercises

Mild dysphagiaModerate dysphagiaSevere dysphagia

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unconscious
  • Uncooperative
  • Those with oropharyngeal structural damage
  • Patients with malignancies involving the head and neck region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Şehir Hastanesi

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 16633876BACKGROUND

  • 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. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

    PMID: 28122885RESULT

MeSH Terms

Conditions

Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Nazife K Kapan, Dr.

CONTACT

03125526000nazifekapan@gmail.com

Müyesser A Aras, Prof. Dr.

CONTACT

03125526000drmuyesser@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 4, 2021

Study Start

February 1, 2021

Primary Completion

May 30, 2021

Study Completion

June 30, 2021

Last Updated

February 4, 2021

Record last verified: 2021-02

Locations

TU(1)