Post-stroke Fatigue and Clinical Parameters

November 14, 2025 updated by: Ayşe A Küçükdeveci, MD, Ankara University

Frequency of Post-stroke Fatigue and Its Relationship With Clinical Parameters

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06530
        • Recruiting
        • Ankara University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ayşe A. Küçükdeveci, MD, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Stroke patients admitted to Ankara University Faculty of Medicine, Physical Medicine and Rehabilitation Clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Severity Scale
Time Frame: Baseline
The Fatigue Severity Scale was first used in 1989 by Krupp et al. to assess fatigue in patients with Multiple Sclerosis and Systemic Lupus Erythematosus. In stroke, a validity and reliability study was conducted for the first time by Nadarajah et al. in 2017. In our country, a validity and reliability study was conducted in stroke patients by Özyemişçi-Taşkıran et al. in 2019. The FSS is a self-report questionnaire that measures the impact and severity of fatigue in daily life. The FSS consists of 9 items about fatigue scored on a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). The total score is the arithmetic mean of the 9 item scores. The lowest score is 9 points and the highest is 63 points. A total score of 36 points or an average score of 4 or more means that the fatigue is pathological fatigue. The higher the FSS score, the greater the impact of fatigue on daily life. Patients are assessed by asking questions according to their fatigue in the last week.
Baseline
Visual Analog Scale-Fatigue
Time Frame: Baseline
Visual Analog Scale-Fatigue (VAS-Fatigue): The Visual Analog Scale is a 10 cm horizontal line with a legend at each end and is commonly used to measure pain levels. The VAS has been modified and renamed VAS-F to measure pathologic fatigue in cancer. One end of the line (0) indicates no fatigue and the other end (10) indicates unbearable fatigue. The patient will be asked to mark the level of fatigue felt during the last 1 week on a 10 cm line. The possible score will be between 0 and 10, with a higher score indicating a high degree of fatigue.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale-Pain
Time Frame: Baseline
VAS-Pain is a 10 cm horizontal line on which the patient's pain intensity is evaluated. One end of the line (0) indicates no pain and the other end (10) indicates unbearable pain. The patient will be asked to mark on this 10 cm line the level of pain they have felt in their body in the last 1 week. The possible score will be between 0 and 10, with a higher score indicating a higher degree of pain.
Baseline
Hospital Anxiety and Depression Scale
Time Frame: Baseline
The HADS is a 14-item scale including 7 anxiety (HADS-A) and 7 depression (HADS-D) symptoms. The aim of the scale is not to make a diagnosis, but to identify the risk group by screening for anxiety and depression in patients with physical illness in a short time. Each item in the scale is evaluated with a four-point Likert scale scored between 0-3. The maximum total score of each subgroup is 21, and scores between 0-7 are considered normal, while scores of 11 and above are considered mood disorders.
Baseline
Athens Insomnia Scale
Time Frame: Baseline
AİS is a psychometric self-assessment tool developed by Soldatos et al. to determine the severity and impact of insomnia encountered in a wide variety of clinical and research settings. It consists of eight items: Sleep induction, awakenings during the night, final awakening earlier than desired, total sleep duration, overall sleep quality, sense of well-being during the day, functioning capacity during the day (physical and mental), and sleepiness during the day. Each item is scored between 0-3 points. The higher the score, the poorer the sleep quality.
Baseline
Brunnstrom Motor Recovery Staging
Time Frame: Baseline
It is used to evaluate hand, upper and lower extremity motor function of patients after stroke. It evaluates patients' synergy patterns, muscle tone and developmental stages of isolated movements. There are 3 main headings: upper extremity, hand and lower extremity and each is graded between 1-7 (1: no movement 7: normal motor function).
Baseline
Mini Mental State Examination
Time Frame: Baseline
It has been shown that it can be used as a cognitive screening test in patients with brain injury. Scoring in the Mini Mental State Examination is between 0-30. Scores between 24 and 30 are considered normal, while scores of 23 and below usually indicate cognitive impairment.
Baseline
Montreal Cognitive Assessment
Time Frame: Baseline
The MoCA was developed as a rapid screening test for mild cognitive impairment. It is a 30-point test assessing visual/spatial-executive functions, naming, memory, attention, language, abstract thinking, calculation, delayed recall and orientation. Higher scores indicate better cognitive status. A score of 21 or above is considered normal.
Baseline
Modified Ashworth Scale
Time Frame: Baseline
MAS is the most preferred scale to assess spasticity in the clinic. The scale, which was defined by Ashworth by scoring in 4 categories between 0-3, was modified by Bohannon and Smith in 1987 and a 1+ parameter was added to the scoring
Baseline
6 Minute Walk Test
Time Frame: Baseline
The 6-minute walk test will be used to assess physical capacity. In this test, participants walk for 6 minutes at the maximum possible walking speed for a distance of 30 meters, with marked areas every 3 meters, without running. Participants should be rested before the test. Heart rate, blood pressure and oxygen saturation are recorded before and after the test, as well as walking distance at the end of the test. In our study, we will only record walking distance. Walking distance is an indicator of functional capacity. In this test, which is a close assessment method to the submaximal exercise test, healthy people can walk an average of 400-700 meters. Although 6DYT is frequently used in the clinic to evaluate treatment response in cardiac and pulmonary diseases, it is also a meaningful scale for functional capacity in stroke patients.
Baseline
Functional Ambulation Classification
Time Frame: Baseline
The FAS is an assessment scale that shows the ambulation level of patients, whether they can walk or not, or if they can walk, how much help they need. This scale was developed by Holden et al. in 1984 on patients with walking difficulties due to neurological impairment, including stroke patients. It is graded from 0 to 5 (Grade 0 is non-ambulatory, Grade 5 is independent ambulation on all surfaces).
Baseline
Modified Barthel Index
Time Frame: Baseline
It is used to assess the level of independence in activities of daily living. It is an index that evaluates transfer, ambulation, use of wheelchair, climbing up and down stairs, feeding, dressing, personal care, bathing, toilet use, urinary and fecal continence parameters and evaluates patients in 5 groups according to these parameter scores. In these groups, which are evaluated from 1 to 5, 1 is considered as inadequate to do work, while 5 is considered as completely independent. The scale is evaluated over 100 points in total. A score of 100 indicates complete independence and a score of zero indicates complete dependence.
Baseline
Stroke Impact Scale Version 3.0
Time Frame: Baseline
This multidimensional scale consists of 8 subsections (strength, hand function, activities of daily living, mobility, communication, emotion, memory and social participation) and a total of 59 questions. Each question scores the difficulty experienced in the past week on a 5-point Likert scale. A score of 1 indicates that the patient was unable to complete the item, while a score of 5 indicates that the patient completed the item without any difficulty. A low score indicates poor quality of life. In addition to the 8 subsections, the SİS v3.0 also assesses the perception of recovery after stroke with a 0-100 point visual analog scale (0: No recovery, 100: Complete recovery).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Principal Investigator: Ayşe A. Küçükdeveci, Prof, Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2024

Primary Completion (Estimated)

January 29, 2026

Study Completion (Estimated)

January 29, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • İ07-516-24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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