Study Results
Results pending
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Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
107 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-11-21
Study Completion Date
2026-01-29
Brief Summary
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This study aims to determine the frequency of post-stroke fatigue (PSF) in patients experiencing their first-ever stroke and admitted to our clinic. PSF is a common and debilitating condition that significantly impacts patients' recovery and quality of life. The study will also explore the association between fatigue severity and various demographic and clinical factors such as age, gender, stroke type and duration, pain, mood disorders, sleep quality, motor and cognitive functions, spasticity, physical capacity, ambulation, independence in daily living activities, and health-related quality of life. Patients over 18 years old, at least three months post-stroke, and meeting specific inclusion criteria will be recruited. Fatigue will be assessed using validated scales including the Fatigue Severity Scale and Visual Analog Scale-Fatigue. Additional assessments will measure pain, anxiety, depression, sleep disturbances, motor and cognitive status, spasticity, physical endurance, functional mobility, and daily activity independence. The findings are expected to contribute to a better understanding of PSF and help inform more effective rehabilitation strategies.
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Detailed Description
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According to the definition of the World Health Organization, stroke is defined as "rapidly developing clinical manifestations of focal (or global) impairment of cerebral function that lasts longer than 24 hours or may result in death and has no apparent cause other than vascular origin". Stroke is the second leading cause of death in the world. It is also the leading cause of disability and accounts for a significant proportion of hospital admissions and health expenditures in industrialized societies. Stroke has many complications, one of which is fatigue. Fatigue can be defined as a decrease in physical and/or mental performance resulting from changes in central, psychological and/or environmental factors. Normal fatigue is a generalized state of tiredness resulting from overexertion and improves with rest. In contrast, "pathologic fatigue", often experienced by patients with neurological disorders, is chronic fatigue unrelated to previous levels of exertion and usually does not improve with rest. Post-stroke fatigue can be considered as a type of pathologic fatigue. Post-stroke fatigue is one of the most common symptoms 3 months after stroke. Half of the patients may still experience fatigue 1 year after stroke and this condition may last for years. The prevalence of post-stroke fatigue has been reported to vary between 39% and 68%. Post-stroke fatigue negatively affects the quality of life of stroke patients and constitutes a significant barrier to recovery, especially in participation in rehabilitation programs. Therefore, understanding post-stroke fatigue is an important issue for healthcare professionals in terms of implementing effective rehabilitation programs in patients with stroke. However, little is known about the etiology and effective management of post-stroke fatigue. Numerous factors have been shown to be associated with post-stroke fatigue, including age, gender, depression, stroke severity, stroke type and lesion location, pain, but these risk factors are not consistent across all studies. The lack of appropriate objective measurement tools may be one of the reasons for the poor understanding of post-stroke fatigue. Several tools are available to assess fatigue, including the Fatigue Rating Scale, Fatigue Impact Scale, Fatigue Severity Scale (FSS) and Visual Analogue Scale-Fatigue. The Fatigue Severity Scale (FSS) is the most commonly used fatigue assessment scale in stroke patients and was originally developed to measure fatigue in patients with Multiple Sclerosis and Systemic Lupus Erythematosus. In the literature, there are studies investigating the frequency of fatigue after stroke and its relationship with various demographic and clinical parameters. In our country, there are a few studies evaluating the frequency of fatigue after stroke. There is no complete clarity in terms of both the frequency and the factors associated with fatigue in the studies. Our primary aim in this study is to determine the frequency of post-stroke fatigue in first-time stroke patients admitted to our clinic. Our secondary aim is to evaluate the relationship between fatigue severity and demographic and clinical characteristics of the patients such as age, gender, education level, stroke type, stroke duration and severity of pain, anxiety, depression, sleep status, motor and cognitive function, spasticity, physical capacity, functional ambulation, level of independence in activities of daily living and health-related quality of life.
Method: The study will include patients who were diagnosed with stroke for the first time according to the World Health Organization definition, who were over 18 years of age, whose general condition was stable after stroke and at least 3 months have passed since the event, among the patients followed up in the Department of Physical Medicine and Rehabilitation of Ankara University Faculty of Medicine Ibn-i Sina and Cebeci hospitals. This study will be conducted within the scope of good clinical practices and all patients will be asked to give consent to the study by reviewing the informed consent form before the study.
Inclusion Criteria:
* Being diagnosed with stroke according to definition by the World Health Organization
* Being over 18 years of age
* Having had a stroke confirmed by Computed Tomography (CT) and/or Magnetic Resonance Imaging (MRI)
* At least 3 months after stroke
* At least stage 2 according to the Functional Ambulation Classification
* Agreed to participate in the study and signed the informed consent form
Exclusion Criteria:
* Previous history of stroke
* Communication problems due to reasons such as aphasia and dementia
* Patients who are illiterate
* Cognitive functional impairment who cannot take commands (MMSE\<24)
* Dİagnoses such as cancer, heart failure, liver failure, renal failure that may cause fatigue
* Signs of systemic infection
* History of subarachnoid hemorrhage
Demographic information (gender, age, height, weight, body mass index, occupation), medical history, type of lesion (ischemic, hemorrhagic), duration of disease, laboratory values such as vitamin B12, vitamin D, hemoglobin and albumin levels and current treatments will be obtained from the patients who agree to participate in the study and meet the inclusion criteria and this information will be recorded in the patient follow-up form. Fatigue Severity Scale (FSS) will be used to assess fatigue after stroke. In addition, the Visual Analog Scale-Fatigue (VAS-Fatigue) will be used to determine the severity of fatigue. Pain severity will be assessed using the Visual Analog Scale-Pain (VAS-Pain), depression and anxiety will be assessed using the Hospital Anxiety and Depression Scale, sleep quality will be assessed using the Athens Insomnia Scale, motor function will be assessed using the Brunnstrom Motor Recovery Staging, and cognitive function will be assessed using the Mini Mental State Examination and Montreal Cognitive Assessment. The level of spasticity will be assessed with the Modified Ashworth Scale, physical capacity with the 6-minute walk test, functional ambulation with the Functional Ambulation Classification, independence in activities of daily living with the Modified Barthel Index, and health-related quality of life with the Stroke Impact Scale v3.0
Method: The study will include patients who were diagnosed with stroke for the first time according to the World Health Organization definition, who were over 18 years of age, whose general condition was stable after stroke and at least 3 months have passed since the event, among the patients followed up in the Department of Physical Medicine and Rehabilitation of Ankara University Faculty of Medicine Ibn-i Sina and Cebeci hospitals. This study will be conducted within the scope of good clinical practices and all patients will be asked to give consent to the study by reviewing the informed consent form before the study.
Inclusion Criteria:
* Being diagnosed with stroke according to definition by the World Health Organization
* Being over 18 years of age
* Having had a stroke confirmed by Computed Tomography (CT) and/or Magnetic Resonance Imaging (MRI)
* At least 3 months after stroke
* At least stage 2 according to the Functional Ambulation Classification
* Agreed to participate in the study and signed the informed consent form
Exclusion Criteria:
* Previous history of stroke
* Communication problems due to reasons such as aphasia and dementia
* Patients who are illiterate
* Cognitive functional impairment who cannot take commands (MMSE\<24)
* Dİagnoses such as cancer, heart failure, liver failure, renal failure that may cause fatigue
* Signs of systemic infection
* History of subarachnoid hemorrhage
Demographic information (gender, age, height, weight, body mass index, occupation), medical history, type of lesion (ischemic, hemorrhagic), duration of disease, laboratory values such as vitamin B12, vitamin D, hemoglobin and albumin levels and current treatments will be obtained from the patients who agree to participate in the study and meet the inclusion criteria and this information will be recorded in the patient follow-up form. Fatigue Severity Scale (FSS) will be used to assess fatigue after stroke. In addition, the Visual Analog Scale-Fatigue (VAS-Fatigue) will be used to determine the severity of fatigue. Pain severity will be assessed using the Visual Analog Scale-Pain (VAS-Pain), depression and anxiety will be assessed using the Hospital Anxiety and Depression Scale, sleep quality will be assessed using the Athens Insomnia Scale, motor function will be assessed using the Brunnstrom Motor Recovery Staging, and cognitive function will be assessed using the Mini Mental State Examination and Montreal Cognitive Assessment. The level of spasticity will be assessed with the Modified Ashworth Scale, physical capacity with the 6-minute walk test, functional ambulation with the Functional Ambulation Classification, independence in activities of daily living with the Modified Barthel Index, and health-related quality of life with the Stroke Impact Scale v3.0
Conditions
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Stroke
Fatigue
Poststroke Fatigue
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* Being diagnosed with stroke according to definition by the World Health Organization
* Being over 18 years of age
* Having had a stroke confirmed by Computed Tomography (CT) and/or Magnetic Resonance Imaging (MRI)
* At least 3 months after stroke
* At least stage 2 according to the Functional Ambulation Classification
* Agreed to participate in the study and signed the informed consent form
* Being over 18 years of age
* Having had a stroke confirmed by Computed Tomography (CT) and/or Magnetic Resonance Imaging (MRI)
* At least 3 months after stroke
* At least stage 2 according to the Functional Ambulation Classification
* Agreed to participate in the study and signed the informed consent form
Exclusion Criteria
* Previous history of stroke
* Communication problems due to reasons such as aphasia and dementia
* Patients who are illiterate
* Cognitive functional impairment who cannot take commands (MMSE\<24)
* Dİagnoses such as cancer, heart failure, liver failure, renal failure that may cause fatigue
* Signs of systemic infection
* History of subarachnoid hemorrhage
* Communication problems due to reasons such as aphasia and dementia
* Patients who are illiterate
* Cognitive functional impairment who cannot take commands (MMSE\<24)
* Dİagnoses such as cancer, heart failure, liver failure, renal failure that may cause fatigue
* Signs of systemic infection
* History of subarachnoid hemorrhage
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Ankara University
OTHER
Sponsor Role
lead
Responsible Party
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Ayşe A Küçükdeveci, MD
Clinical Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Ayşe A. Küçükdeveci, Prof
Role: PRINCIPAL_INVESTIGATOR
Ankara University
Locations
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Ankara University
Ankara, , Turkey (Türkiye)
Site Status
RECRUITING
Countries
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Turkey (Türkiye)
Central Contacts
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Facility Contacts
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References
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Related Links
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https://www.jpmrs.org/uploads/973440954215479.pdf
Related Info
https://search.trdizin.gov.tr/tr/yayin/detay/105939
Related Info
Other Identifiers
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İ07-516-24
Identifier Type: -
Identifier Source: org_study_id
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Intermittent Oro-esophageal Tube on Feeding Hesitancy in Stroke Patients
NCT06312371
NOT_YET_RECRUITING
NA