NCT06668649

Polish Version Fatigue Severity Scale

Validation of Polish Language Version of Fatigue Severity Scale

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 310 (estimated)
• Sponsor: Jakub Antczak · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Fatigue is one of main symptoms in multiple sclerosis, amyotrophic lateral sclerosis and other diseases with profound effect on quality of life and professional and social functioning. Not infrequent it is misdiagnosed as sleepiness or other symptom. Fatigue severity scale is a time efficient and easy to apply instrument to assess the impact of fatigue on patient's life. The aim of this study is to validate the Polish-language version of the Fatigue Severity Scale.

Detailed description

Fatigue is one of main symptoms in multiple sclerosis, amyotrophic lateral sclerosis, post-polio syndrome, stroke, parkinsonism as well as in the chronic fatigue syndrome. It has profound effect on quality of life and professional and social functioning and in multiple sclerosis it is described as the worst symptoms by the 50% of patients. It is defined as the difficulty in initiating and maintaining a sustained mental or physical activity. Not infrequent it is misdiagnosed as sleepiness or other symptom. Fatigue severity scale (FSS) is a time efficient and easy to apply instrument to assess the impact of fatigue on patient's life. It has been translated and validated in Turkish, Russian, Hindi, Portuguese, and many other languages. FSS is a short, nine-item self-report questionnaire. Each item is a Likert scale, scored from one to seven, where seven refers to the most severely expressed aspect of fatigue. The aim of this study is to validate the Polish-language version of the Fatigue Severity Scale (pFSS). This version has been created according to widely accepted, respective standards, including translation by two independent native Polish-language speakers with acquired knowledge of English and backward translation by two independent native English-language speakers with acquired knowledge of Polish as well as with the pretesting on ten patients.

Conditions

• Multiple Sclerosis
• Amyotrophic Lateral Sclerosis
• Stroke, Ischemic

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Testing with Questionnaires	Testing with following Questionnaires: pFSS, Polish-language version of Modified Fatigue Impact Scale, Visual Analogue Scale of Fatigue, EQ-5D-5L (EuroQol-5 dimension) questionnaire, Beck Depression Inventory II. In randomly selected 30 patients and 20 controls questionnaires will be administered twice with two weeks interval to assess the test-retest reliability.

Timeline

• Start date: 2024-11-04
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2024-10-31
• Last updated: 2024-11-08

Locations

2 sites across 1 country: Poland