- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07680049
The Mediating Role of Balance in the Relationship Between Fatigue and Fear of Falling in Individuals With Multiple Sclerosis
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Uskudar
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Istanbul, Uskudar, Tyrkia (Türkiye), 34662
- Uskudar University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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.
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Observational Model: Cross-Sectional
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Falls Efficacy Scale-International
Tidsramme: Time Frame: Baseline (single assessment)
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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.
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Time Frame: Baseline (single assessment)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Fatigue Severity Scale (FSS)
Tidsramme: Baseline (single assessment)
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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.
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Baseline (single assessment)
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Baseline (single assessment)
Tidsramme: Baseline (single assessment)
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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.
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Baseline (single assessment)
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Bakshi R. Fatigue associated with multiple sclerosis: diagnosis, impact and management. Mult Scler. 2003 Jun;9(3):219-27. doi: 10.1191/1352458503ms904oa.
- Nilsagard Y, Lundholm C, Denison E, Gunnarsson LG. Predicting accidental falls in people with multiple sclerosis -- a longitudinal study. Clin Rehabil. 2009 Mar;23(3):259-69. doi: 10.1177/0269215508095087.
- Hebert JR, Corboy JR. The association between multiple sclerosis-related fatigue and balance as a function of central sensory integration. Gait Posture. 2013 May;38(1):37-42. doi: 10.1016/j.gaitpost.2012.10.015. Epub 2012 Nov 28.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Uskudar-MS
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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