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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07680049
Enrollment
40
Registered
2026-07-01
Start date
2026-07-01
Completion date
2026-09-01
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Fatigue, Multiple Sclerosis, Postural Balance, Fear

Brief summary

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.

Detailed description

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.

Interventions

OTHERObservational Model: Cross-Sectional

Observational Model: Cross-Sectional

Sponsors

Uskudar University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Falls Efficacy Scale-InternationalTime 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.

Secondary

MeasureTime frameDescription
Fatigue Severity Scale (FSS)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)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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026