Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288243
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2024-02-15
Brief Title:
Functionality Cognition And Swallowing Skills In Patients With AcuteSTROKE
Sponsor:
Medipol University
Organization:
Medipol University
Study Overview
Official Title:
Examination Of The Correlation Between Functionality And Cognition And Swallowing Skills In Patients With Acute Stroke
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 MMASATR-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 124Written 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 240 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 p005 in statistical analysis
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 MMASATR-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 124Written 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 240 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 p005 in statistical analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None