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The Mediating Role of Balance in the Relationship Between Fatigue and Fear of Falling in Individuals With Multiple Sclerosis

25. juni 2026 opdateret af: Uskudar University
Fatigue, balance impairment, and fear of falling are common problems in individuals with Multiple Sclerosis (MS). Previous studies have shown significant associations among these variables; however, the mechanisms underlying the relationship between fatigue and fear of falling remain unclear. It is possible that fatigue increases fear of falling indirectly through its negative effects on balance performance.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

Multiple sclerosis (MS) is a chronic demyelinating and neurodegenerative disease of the central nervous system that frequently leads to fatigue, balance impairment, and fear of falling. These symptoms negatively affect mobility, independence, participation in daily activities, and quality of life. Fatigue is one of the most common and disabling symptoms in individuals with MS and may contribute to impaired balance and an increased risk of falls.

Fear of falling is highly prevalent in people with MS and is associated with reduced physical activity, activity avoidance, and functional decline. Balance impairment is another common manifestation of MS and may represent an important mechanism linking fatigue to fear of falling. However, although fatigue, balance, and fear of falling have been investigated separately, the mediating role of balance in the relationship between fatigue and fear of falling has not been sufficiently explored.

The aim of this cross-sectional observational study is to investigate whether balance mediates the relationship between fatigue and fear of falling in individuals with multiple sclerosis. Fatigue will be assessed using the Fatigue Severity Scale (FSS), balance performance will be evaluated using the Mini-Balance Evaluation Systems Test (Mini-BESTest), and fear of falling will be measured using the Falls Efficacy Scale-International (FES-I).

The findings of this study are expected to improve the understanding of the mechanisms underlying fear of falling in individuals with MS and provide evidence to support the development of rehabilitation programs targeting balance to reduce fear of falling and improve functional outcomes.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

40

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Üsküdar
      • Istanbul, Üsküdar, Tyrkiet (Türkiye), 34662
        • Uskudar university
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

N/A

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population will consist of adults diagnosed with multiple sclerosis who are clinically stable and able to complete the study assessments. Eligible participants will be recruited from the outpatient neurology and physical medicine and rehabilitation clinics of Başkent University.

Beskrivelse

Inclusion Criteria:

  • Age 18-65 years
  • Neurologist-confirmed MS diagnosis
  • No relapse within the previous 30 days
  • Ability to walk independently or with an assistive device
  • Ability to understand instructions
  • Voluntary participation

Exclusion Criteria:

  • Recent MS relapse
  • Severe vestibular disorder
  • Other neurological diseases
  • Severe orthopedic conditions affecting mobility
  • Recent lower extremity surgery or trauma
  • Cardiopulmonary conditions limiting assessment

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Individuals with Multiple Sclerosis
Adults diagnosed with multiple sclerosis who meet the eligibility criteria will participate in a single assessment session to evaluate fatigue, balance, and fear of falling.
Observational Model: Cross-Sectional

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Falls Efficacy Scale-International
Tidsramme: Time Frame: Baseline (single assessment)
Fear of falling will be assessed using the Falls Efficacy Scale-International (FES-I). The FES-I is a 16-item questionnaire that evaluates concern about falling during a range of daily activities. Total scores range from 16 to 64, with higher scores indicating greater fear of falling.
Time Frame: Baseline (single assessment)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fatigue Severity Scale (FSS)
Tidsramme: Baseline (single assessment)
Fatigue severity will be assessed using the Fatigue Severity Scale (FSS). The FSS consists of 9 items rated on a 7-point Likert scale. The total score is calculated as the mean of all items, with higher scores indicating greater fatigue severity.
Baseline (single assessment)
Baseline (single assessment)
Tidsramme: Baseline (single assessment)
Balance performance will be evaluated using the Mini-Balance Evaluation Systems Test (Mini-BESTest). The Mini-BESTest consists of 14 items assessing dynamic balance. Total scores range from 0 to 28, with higher scores indicating better balance performance.
Baseline (single assessment)

Samarbejdspartnere og efterforskere

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Publikationer og nyttige links

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Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

20. juli 2026

Studieafslutning (Anslået)

25. juli 2026

Datoer for studieregistrering

Først indsendt

25. juni 2026

Først indsendt, der opfyldte QC-kriterier

25. juni 2026

Først opslået (Faktiske)

1. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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