Post-stroke Fatigue and Clinical Parameters

NCT07231172 | Recruiting

• 1 other identifier: İ07-516-24
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Fatigue; Poststroke Fatigue

Keywords

Fatigue, Stroke,; Frequency

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline

• 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.

  Baseline

Secondary Outcomes (11)

• Visual Analog Scale-Pain

  Baseline

• Hospital Anxiety and Depression Scale

  Baseline

• Athens Insomnia Scale

  Baseline

• Brunnstrom Motor Recovery Staging

  Baseline

• Mini Mental State Examination

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, 06530, Turkey (Türkiye)

RECRUITING

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MeSH Terms

Conditions

Stroke; Fatigue

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayşe A. Küçükdeveci, Prof

  Ankara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet Tekeş, MD

CONTACT

+903125082822; yusuf1tekes@gmail.com

Ayşe A. Küçükdeveci, MD, Prof

CONTACT

+903125082822; ayse.kucukdeveci@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 17, 2025
• Study Start: November 21, 2024
• Primary Completion: January 29, 2026
• Study Completion: January 29, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

TU (1)