Stroke, AcuteNCT06288243
Functionality, Cognition And Swallowing Skills In Patients With AcuteSTROKE
An observational study of Stroke, Acute and Swallowing Disorder, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 92 years
- Conditions the study is for
- Stroke, Acute, Swallowing Disorder, Cognitive Impairment
- What is being tested?
- Clinician-observed assessment tests
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2018to 29 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 92 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had an acute stroke and were treated in the neurology clinic
Who may be able to join
- Stroke diagnosis by a specialist neurologist with radiological confirmation cranial computed tomography (CT) or magnetic resonance imaging
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examination Of The Correlation Between Functionality And Cognition And Swallowing Skills In Patients With Acute Stroke
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.
Read the detailed description
Dysphagia after acute stroke is common in the early stage and risk factors should be defined by actively evaluating it. 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. We evaluated the pre-swallowing skills of stroke patients with the Turkish translation of MMASA, a current screening test (TR-MMASA). We focused on the fact that the level of functionality and cognition may also be low in acute stroke patients with a high risk of swallowing disorders. We also investigated the consistency of the TR-MMASA swallowing screening test, which we assumed might be compatible with other tests evaluating cognition and functionality.
The 97 acute stroke patients included in the study were grouped in terms of lesion type, affected side, and risk factors for stroke. Inclusion criteria were a stroke diagnosis by a specialist neurologist with radiological confirmation cranial computed tomography (CT) or magnetic resonance imaging. Exclusion criteria were a 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. Data collection was completed by completing the Turkish MMASA(TR-MMASA) dysphagia screening test, Standardized Mini Mental Test (SMMT) and Modified Rankin Scale (MRS) and demographic information forms. In the demographic information form, information about the participants' age, gender, lesion type, affected side, time spent after stroke, dominant side, and education level were recorded.
The study protocol was approved by the Istanbul Medipol University Non-Invasive Clinical Research Ethics Committee (Decree No: 124).Written permission was obtained from Istanbul Training and Research Hospital Neurology Clinic to conduct the study. Written and verbal consent was obtained from the patients through an informed consent form to participate in the study. The consent of the patients who were unable to give consent was obtained from their first-degree relatives. The study was conducted in accordance with the Principles of the Declaration of Helsinki.
SPSS (Statistical Package for the Social Sciences Inc; Chicago, IL, USA) 24.0 statistical package program was used to analyze the data. Descriptive statistics (number-percentage ratios, mean values, standard deviation value, median, minimum-maximum values) were used to express the data obtained in the study. Chi-square test technique was applied to determine whether there is dependency between the variables. ANOVA test was used to determine whether there is a dependency between more than two variables. Confidence interval was accepted as 95% (p<0.05) in statistical analysis.
- Conditions
- Stroke, Acute, Swallowing Disorder, Cognitive Impairment, Stroke, Movement Disorders, Dysphagia
- Being tested
- Clinician-observed assessment tests
- Keywords
- stroke, acute stroke, dysphagia, cognitive status, functionality
- Medical subject headings
- Stroke, Deglutition Disorders, Cognitive Dysfunction, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician-observed assessment testsDiagnostic test
Turkish Modified Mann Swallowing Ability Test, which evaluates swallowing skills Standardized Mini-Mental Test assessing Cognitive Status Modified Rankin Scale to evaluate functionality
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the first 5 months of the study.
Secondary outcomes (2)
The relationship between stroke risk factors and swallowing skills
Is there a significant relationship between TR-MMASA(Turkish Modified Mann Swallowing Ability) test scores and stroke risk factors (low, medium, high)?
Measured: During the first 5 months of the study.
The relationship between demographic informations and swallowing skills
Is there a significant relationship between the scores obtained from the TR-MMASA test and demographic information (age, gender, lesion type(ischemic-hemorragic), affected side(right-left-no motor deficit))?
Measured: During the first 5 months of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Dec 2018
- Primary completion28 May 2019
- Study completion29 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Berber Çiftci, Medipol University
- Investigators
- Seyhun Topbaş, Prof.Dr., Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288243
- Sponsor's protocol ID
- Samatya
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18940639Antonios 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.
PubMed 20123227
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination Of The Correlation Between Functionality And Cognition And Swallowing Skills In Patients With Acute Stroke
- ClinicalTrials.gov ID
- NCT06288243
- Acronym / sponsor ID
- Samatya
- Conditions
- Stroke, Acute, Swallowing Disorder, Cognitive Impairment, Stroke, Movement Disorders, Dysphagia
- Keywords
- stroke, acute stroke, dysphagia, cognitive status, functionality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dysphagia after acute stroke is common in the early stage and risk factors should be defined by actively evaluating it. 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. We evaluated the pre-swallowing skills of stroke patients with the Turkish translation of MMASA, a current screening test (TR-MMASA). We focused on the fact that the level of functionality and cognition may also be low in acute stroke patients with a high risk of swallowing disorders. We also investigated the consistency of the TR-MMASA swallowing screening test, which we assumed might be compatible with other tests evaluating cognition and functionality.
The 97 acute stroke patients included in the study were grouped in terms of lesion type, affected side, and risk factors for stroke. Inclusion criteria were a stroke diagnosis by a specialist neurologist with radiological confirmation cranial computed tomography (CT) or magnetic resonance imaging. Exclusion criteria were a 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. Data collection was completed by completing the Turkish MMASA(TR-MMASA) dysphagia screening test, Standardized Mini Mental Test (SMMT) and Modified Rankin Scale (MRS) and demographic information forms. In the demographic information form, information about the participants' age, gender, lesion type, affected side, time spent after stroke, dominant side, and education level were recorded.
The study protocol was approved by the Istanbul Medipol University Non-Invasive Clinical Research Ethics Committee (Decree No: 124).Written permission was obtained from Istanbul Training and Research Hospital Neurology Clinic to conduct the study. Written and verbal consent was obtained from the patients through an informed consent form to participate in the study. The consent of the patients who were unable to give consent was obtained from their first-degree relatives. The study was conducted in accordance with the Principles of the Declaration of Helsinki.
SPSS (Statistical Package for the Social Sciences Inc; Chicago, IL, USA) 24.0 statistical package program was used to analyze the data. Descriptive statistics (number-percentage ratios, mean values, standard deviation value, median, minimum-maximum values) were used to express the data obtained in the study. Chi-square test technique was applied to determine whether there is dependency between the variables. ANOVA test was used to determine whether there is a dependency between more than two variables. Confidence interval was accepted as 95% (p<0.05) in statistical analysis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 to 92 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had an acute stroke and were treated in the neurology clinic
Key inclusion criteria (1 listed)
- Stroke diagnosis by a specialist neurologist with radiological confirmation cranial computed tomography (CT) or magnetic resonance imaging
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinician-observed assessment testsTurkish Modified Mann Swallowing Ability Test, which evaluates swallowing skills Standardized Mini-Mental Test assessing Cognitive Status Modified Rankin Scale to evaluate functionality | Diagnostic test | – |
Primary outcome
The Correlation Between Swallowing Skills and Cognitive Status
Time frame: During the first 5 months of the study.
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.
The Correlation Between Swallowing Skills and Functionality
Time frame: During the first 5 months of the study.
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.
2 secondary outcomes
The relationship between stroke risk factors and swallowing skills
Time frame: During the first 5 months of the study.
The relationship between demographic informations and swallowing skills
Time frame: During the first 5 months of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Results publication: PubMed 18940639Carnaby-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.
- Results publication: PubMed 20123227Antonios 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seyhun Topbaş, Prof.Dr. study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute and Swallowing Disorder, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Correlation Between Swallowing Skills and Cognitive Status (time frame: During the first 5 months of the study.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06288243, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.