NCT06288243

Brief Summary

Aim: Studies in which the results of the screening test evaluating swallowing skills in acute stroke patients are evaluated together with other components that may affect swallowing function are limited. The aim of this study is to determine which factors are associated with swallowing abilities in patients with acute stroke, including lesion location, cognitive level, clinical features, risk factors for stroke, and level of functionality. Methods: The 97 acute stroke patients included in the study were grouped in terms of lesion type, affected side, and risk factors for stroke. Turkish MMASA (TR-MMASA) was used to evaluate the swallowing ability of the patients. Additionally, Standardized Mini Mental Test (SMMT) and Modified Rankin Scale (MRS) were applied to evaluate cognition level and functionality, respectively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2019

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

February 15, 2024

Last Update Submit

February 24, 2024

Conditions

Keywords

strokeacute strokedysphagiacognitive statusfunctionality

Outcome Measures

Primary Outcomes (2)

  • The Correlation Between Swallowing Skills and Cognitive Status

    Is there correlation between the scores obtained from the TR-MMASA(Turkish Modified Mann Swallowing Ability test and the scores obtained from the SMMT(Standardized Mini Mental Test)? The TR-MMASA test is a test based on clinical observation that gives a score between 92 and 100 for the patient's swallowing skills. A score of 92 and below means non-oral nutrition, and a score above 92 means that it can be fed orally. SMMT test is a test that measures the cognitive level of the patient based on clinical observation between 0-30. As the score value decreases, it means that the cognitive level worsens.

    During the first 5 months of the study.

  • The Correlation Between Swallowing Skills and Functionality

    Is there correlation between the scores obtained from the TR-MMASA(Turkish Modified Mann Swallowing Ability) test and the scores obtained from the MRS(Modified Rankin Scale) test? The TR-MMASA test is a test based on clinical observation that gives a score between 92 and 100 for the patient's swallowing skills. A score of 92 and below means non-oral nutrition, and a score above 92 means that it can be fed orally. MRS test is the test that evaluates the patient's functional independence. Scoring 0-2 points from the test means that the patient is functionally dependent, and scoring 3-6 points means that the patient is functionally independent.

    During the first 5 months of the study.

Secondary Outcomes (2)

  • The relationship between stroke risk factors and swallowing skills

    During the first 5 months of the study.

  • The relationship between demographic informations and swallowing skills

    During the first 5 months of the study.

Interventions

Turkish Modified Mann Swallowing Ability Test, which evaluates swallowing skills Standardized Mini-Mental Test assessing Cognitive Status Modified Rankin Scale to evaluate functionality

Eligibility Criteria

Age45 Years - 92 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who had an acute stroke and were treated in the neurology clinic

You may qualify if:

  • Stroke diagnosis by a specialist neurologist with radiological confirmation cranial computed tomography (CT) or magnetic resonance imaging

You may not qualify if:

  • History of head and neck cancer or trauma,
  • Having received radiotherapy in the last 12 months,
  • A neurological or neurodegenerative disorder independent of stroke affecting swallowing function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol University

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • Carnaby-Mann G, Lenius K. The bedside examination in dysphagia. Phys Med Rehabil Clin N Am. 2008 Nov;19(4):747-68, viii. doi: 10.1016/j.pmr.2008.05.008.

  • Antonios N, Carnaby-Mann G, Crary M, Miller L, Hubbard H, Hood K, Sambandam R, Xavier A, Silliman S. Analysis of a physician tool for evaluating dysphagia on an inpatient stroke unit: the modified Mann Assessment of Swallowing Ability. J Stroke Cerebrovasc Dis. 2010 Jan;19(1):49-57. doi: 10.1016/j.jstrokecerebrovasdis.2009.03.007.

MeSH Terms

Conditions

StrokeDeglutition DisordersCognitive DysfunctionMovement Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Seyhun Topbaş, Prof.Dr.

    Medipol University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Lecturer

Study Record Dates

First Submitted

February 15, 2024

First Posted

March 1, 2024

Study Start

December 1, 2018

Primary Completion

May 28, 2019

Study Completion

May 29, 2019

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations