NCT07680049

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2026

Completed
Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

19 days

First QC Date

June 25, 2026

Last Update Submit

June 25, 2026

Conditions

Multiple Sclerosis

Keywords

FatigueMultiple SclerosisPostural BalanceFear

Outcome Measures

Primary Outcomes (1)

  • Falls Efficacy Scale-International

    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)

Secondary Outcomes (2)

  • Fatigue Severity Scale (FSS)

    Baseline (single assessment)

  • Baseline (single assessment)

    Baseline (single assessment)

Study Arms (1)

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.

Other: Observational Model: Cross-Sectional

Interventions

Observational Model: Cross-SectionalOTHER

Observational Model: Cross-Sectional

Individuals with Multiple Sclerosis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Üsküdar university

Istanbul, Üsküdar, 34662, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 19218300BACKGROUND

  • Bakshi R. Fatigue associated with multiple sclerosis: diagnosis, impact and management. Mult Scler. 2003 Jun;9(3):219-27. doi: 10.1191/1352458503ms904oa.

    PMID: 12814166RESULT

  • 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.

    PMID: 23200463RESULT

MeSH Terms

Conditions

Multiple SclerosisFatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

osman çoban, phD

CONTACT

00905337242919osman.coban@uskudar.edu.tr

günay çimen aysal, phd

CONTACT

00905336425822gnycimen@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 1, 2026

Study Start

July 1, 2026

Primary Completion

July 20, 2026

Study Completion

July 25, 2026

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)