NCT07736482

Brief Summary

This cross-sectional observational study aims to investigate the relationship between obstacle crossing performance under single-task and dual-task conditions and the levels of fatigue and disability in individuals with Relapsing-Remitting Multiple Sclerosis (RRMS). Walking performance will be assessed under standard walking and obstacle crossing conditions with and without a concurrent cognitive task. The study will examine how increased task complexity affects walking performance and its association with fatigue, disability, cognition, and functional mobility.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Mar 2026Feb 2027

Study Start

First participant enrolled

March 20, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 26, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2027

Expected
Last Updated

July 31, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

July 26, 2026

Last Update Submit

July 30, 2026

Conditions

Keywords

Multiple sclerosisDual TaskFatigue

Outcome Measures

Primary Outcomes (1)

  • Dual-Task Cost During Obstacle Crossing

    Walking performance will be assessed using the 10-Meter Walk Test under four conditions: single-task walking, dual-task walking with serial-3 subtraction, single-task obstacle crossing, and dual-task obstacle crossing with serial-3 subtraction. Walking time and cognitive task performance will be recorded. Dual-Task Cost (DTC, %) will be calculated to quantify the effect of performing a concurrent cognitive task during walking.

    Baseline

Secondary Outcomes (5)

  • The Modified Fatigue Impact Scale (MFIS)

    Baseline

  • Multiple Sclerosis Walking Scale-12 (MSWS-12)

    Baseline

  • Monitoring My Multiple Sclerosis Scale (MMMS)

    Baseline

  • Tampa Scale for Kinesiophobia (TSK)

    Baseline

  • Fatigue Severity Scale (FSS)

    Baseline

Study Arms (1)

Relapsing-Remitting Multiple Sclerosis

Adults aged 18 to 65 years with a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) according to the 2017 McDonald criteria, an Expanded Disability Status Scale (EDSS) score between 0 and 6, a Montreal Cognitive Assessment (MoCA) score of 26 or higher, and a clinically stable disease course during the previous 6 months. Participants will undergo observational assessments of walking, obstacle crossing performance, fatigue, cognition, functional mobility, and fear of movement. No intervention will be administered.

Eligibility Criteria

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

Adults aged 18 to 65 years with Relapsing-Remitting Multiple Sclerosis who are followed at the Neurology Outpatient Clinic of Kocaeli City Hospital, have an EDSS score between 0 and 6, are clinically stable, and meet all eligibility criteria.

You may qualify if:

  • Age between 18 and 65 years.
  • Diagnosis of Multiple Sclerosis according to the 2017 McDonald criteria.
  • Diagnosis of Relapsing-Remitting Multiple Sclerosis.
  • Expanded Disability Status Scale (EDSS) score between 0 and 6.
  • Clinically stable disease during the previous 6 months.
  • Montreal Cognitive Assessment (MoCA) score of 26 or higher.
  • Able to speak and understand Turkish.
  • Able to provide written informed consent.

You may not qualify if:

  • Multiple sclerosis relapse within the previous month.
  • Physician-diagnosed psychiatric disorder.
  • Neurological, orthopedic, cardiac, or pulmonary disease other than Multiple Sclerosis that could interfere with study assessments.
  • Montreal Cognitive Assessment (MoCA) score below 26.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, Merkez, 03000, Turkey (Türkiye)

RECRUITING

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

Yunus Emre Kundakcı, Assoc. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

July 26, 2026

First Posted

July 30, 2026

Study Start

March 20, 2026

Primary Completion

July 25, 2026

Study Completion (Estimated)

February 20, 2027

Last Updated

July 31, 2026

Record last verified: 2026-02

Locations