Clinical trial NCT06288243: Functionality, Cognition And Swallowing Skills In Patients With AcuteSTROKE
Official title: Examination Of The Correlation Between Functionality And Cognition And Swallowing Skills In Patients With Acute Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Swallowing Disorder
Cognitive Impairment
Stroke
Movement Disorders
Dysphagia
Keywords: stroke
acute stroke
dysphagia
cognitive status
functionality
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 97
Sex: ALL
Minimum age (years): 45
Maximum age (years): 92
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who had an acute stroke and were treated in the neurology clinic

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The Correlation Between Swallowing Skills and Cognitive Status
timeFrame: During the first 5 months of the study.
measure: The Correlation Between Swallowing Skills and Functionality
timeFrame: During the first 5 months of the study.
Secondary outcomes:
measure: The relationship between stroke risk factors and swallowing skills
timeFrame: During the first 5 months of the study.
measure: The relationship between demographic informations and swallowing skills
timeFrame: During the first 5 months of the study.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medipol University
Study officials:
affiliation: Medipol University
name: Seyhun Topbaş, Prof.Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.