Clinical trial NCT06668649: Polish Version Fatigue Severity Scale
Official title: Validation of Polish Language Version of Fatigue Severity Scale
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Amyotrophic Lateral Sclerosis
Stroke, Ischemic
Keywords: Fatigue
Multiple Sclerosis
stroke
quality of life
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
Collaborators: name: Institute of Psychiatry and Neurology, Warsaw
First posted: 2024-10-31
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from the neurologic ambulatories and neurologic clinics of Jagiellonian University Medical College in Cracow and of Institute of Psychiatry and Neurology in Warsaw. Healthy controls will be recruited from personel of those facitlites as well as from the relatives of members of research team.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of definite multiple sclerosis or definite, laboratory-supported multiple sclerosis, or definite amyotrophic lateral sclerosis, or probable amyotrophic lateral sclerosis or probable, laboratory supported amyotrophic lateral sclerosis or ischemic stroke or - for healthy controls - lack of diseases, pharmacotherapy or habits, which could induce abnormal tiredness

Exclusion Criteria:

* Presence of cognitive deficits or behavioral disorder, which could disturb participation in the study.

Primary outcomes:
measure: Internal Consistency
timeFrame: Through study completion, an average of 1 year
measure: Validity
timeFrame: Through study completion, an average of 1 year
measure: Reliability
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Impact of fatigue on quality of life - index
timeFrame: Through study completion, an average of 1 year
measure: Impact of fatigue on quality of life - visual analogue scale
timeFrame: Through study completion, an average of 1 year
measure: Impact of fatigue on depression
timeFrame: Through study completion, an average of 1 year
measure: Difference in fatigue level between patients and controls
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Jagiellonian University Medical College, Department of Neurology
state: Lesser Poland
city: Warsaw
country: Poland
facility: Institute of Psychiatry and Neurology
Study officials:
affiliation: Jagiellonian University
name: Jakub M Antczak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993 Dec;46(12):1417-32. doi: 10.1016/0895-4356(93)90142-n.