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StrokeNCT07231172

Post-stroke Fatigue and Clinical Parameters

An observational study of Stroke and Fatigue, run by Ankara University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Fatigue, Poststroke Fatigue
How many people
107 participants
Where
1 siteTurkey (Türkiye)
Study dates
21 Nov 2024to 29 Jan 2026
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mehmet Tekeş, MD contact

+903125082822

yusuf1tekes@gmail.com

Ayşe A. Küçükdeveci, MD, Prof contact

+903125082822

ayse.kucukdeveci@gmail.com

Turkey (Türkiye)1 site, 1 recruiting

  • Ankara University

    Ankara, 06530

    Mehmet Tekeş, MD, +903125082822, yusuf1tekes@gmail.com

    Ayşe A. Küçükdeveci, MD, Prof, +903125082822, ayse.kucukdeveci@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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

Keywords
Fatigue, Stroke,, Frequency
Medical subject headings
Stroke, Fatigue

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fatigue Severity Scale

    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.

    Measured: Baseline

  2. Visual Analog Scale-Fatigue

    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.

    Measured: Baseline

Secondary outcomes (11)

  1. Visual Analog Scale-Pain

    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.

    Measured: Baseline

  2. Hospital Anxiety and Depression Scale

    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.

    Measured: Baseline

  3. Athens Insomnia Scale

    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.

    Measured: Baseline

  4. Brunnstrom Motor Recovery Staging

    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).

    Measured: Baseline

  5. Mini Mental State Examination

    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.

    Measured: Baseline

  6. Montreal Cognitive Assessment

    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.

    Measured: Baseline

  7. Modified Ashworth Scale

    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

    Measured: Baseline

  8. 6 Minute Walk Test

    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.

    Measured: Baseline

  9. Functional Ambulation Classification

    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).

    Measured: Baseline

  10. Modified Barthel Index

    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.

    Measured: Baseline

  11. Stroke Impact Scale Version 3.0

    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).

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2025
  2. Study start21 Nov 2024
  3. Primary completion29 Jan 2026 (estimated)
  4. Study completion29 Jan 2026 (estimated)

Resources

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
107 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07231172
Sponsor's protocol ID
İ07-516-24
Status last verified
Nov 2025
First submitted
14 Nov 2025
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Duncan PW, Bode RK, Min Lai S, Perera S; Glycine Antagonist in Neuroprotection Americans Investigators. Rasch analysis of a new stroke-specific outcome scale: the Stroke Impact Scale. Arch Phys Med Rehabil. 2003 Jul;84(7):950-63. doi: 10.1016/s0003-9993(03)00035-2.

    PubMed 12881816

  • Duncan PW, Wallace D, Lai SM, Johnson D, Embretson S, Laster LJ. The stroke impact scale version 2.0. Evaluation of reliability, validity, and sensitivity to change. Stroke. 1999 Oct;30(10):2131-40. doi: 10.1161/01.str.30.10.2131.

    PubMed 10512918

  • Kucukdeveci AA, Yavuzer G, Tennant A, Suldur N, Sonel B, Arasil T. Adaptation of the modified Barthel Index for use in physical medicine and rehabilitation in Turkey. Scand J Rehabil Med. 2000 Jun;32(2):87-92.

    PubMed 10853723

  • Shah S, Vanclay F, Cooper B. Improving the sensitivity of the Barthel Index for stroke rehabilitation. J Clin Epidemiol. 1989;42(8):703-9. doi: 10.1016/0895-4356(89)90065-6.

    PubMed 2760661

  • Mehrholz J, Wagner K, Rutte K, Meissner D, Pohl M. Predictive validity and responsiveness of the functional ambulation category in hemiparetic patients after stroke. Arch Phys Med Rehabil. 2007 Oct;88(10):1314-9. doi: 10.1016/j.apmr.2007.06.764.

    PubMed 17908575

  • Holden MK, Gill KM, Magliozzi MR, Nathan J, Piehl-Baker L. Clinical gait assessment in the neurologically impaired. Reliability and meaningfulness. Phys Ther. 1984 Jan;64(1):35-40. doi: 10.1093/ptj/64.1.35.

    PubMed 6691052

  • Macchiavelli A, Giffone A, Ferrarello F, Paci M. Reliability of the six-minute walk test in individuals with stroke: systematic review and meta-analysis. Neurol Sci. 2021 Jan;42(1):81-87. doi: 10.1007/s10072-020-04829-0. Epub 2020 Oct 16.

    PubMed 33064231

  • Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.

    PubMed 3809245

  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

    PubMed 15817019

  • Bour A, Rasquin S, Boreas A, Limburg M, Verhey F. How predictive is the MMSE for cognitive performance after stroke? J Neurol. 2010 Apr;257(4):630-7. doi: 10.1007/s00415-009-5387-9. Epub 2009 Nov 22.

    PubMed 20361295

  • Elhan AH, Kutlay S, Kucukdeveci AA, Cotuk C, Ozturk G, Tesio L, Tennant A. Psychometric properties of the Mini-Mental State Examination in patients with acquired brain injury in Turkey. J Rehabil Med. 2005 Sep;37(5):306-11. doi: 10.1080/16501970510037573.

    PubMed 16203619

  • Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.

    PubMed 12794644

  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PubMed 1202204

  • Brunnstrom S. Motor testing procedures in hemiplegia: based on sequential recovery stages. Phys Ther. 1966 Apr;46(4):357-75. doi: 10.1093/ptj/46.4.357. No abstract available.

    PubMed 5907254

  • Elbi H, Batum M, Ozturk EO, Balcan MV, Ak AK, Yilmaz H, Aydemir O. Adaptation into Turkish and Psychometric Properties of Athens Insomnia Scale. Noro Psikiyatr Ars. 2024 Apr 1;61(2):154-159. doi: 10.29399/npa.28575. eCollection 2024.

    PubMed 38868854

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Fatigue, run by Ankara 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 Nov 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mehmet Tekeş, MD (+903125082822, yusuf1tekes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue Severity Scale (time frame: Baseline). 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 NCT07231172, which also lists 48 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 17 Nov 2025.

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