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NCT Number: NCT07736482

Relationship Between Single- and Dual-Task Obstacle Crossing Performance and Fatigue and Disability in Multiple Sclerosis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Afyonkarahisar Health Sciences University

Afyonkarahisar, Merkez, 03000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Yunus E Kundakcı, Assoc. Prof.

CONTACT

[email protected]

+905078638878

About this study

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system that frequently causes gait impairment, fatigue, cognitive dysfunction, and reduced functional mobility. Since daily activities often require simultaneous motor and cognitive performance, assessment under dual-task conditions provides clinically meaningful information beyond conventional gait evaluation.

Obstacle crossing represents a more demanding walking task than level walking and may better reflect mobility challenges encountered in everyday life. Although dual-task walking has been investigated in individuals with MS, studies examining obstacle crossing performance under both single-task and dual-task conditions and its relationship with fatigue and disability remain limited.

This cross-sectional observational study will include men and women aged 18 to 65 years with Relapsing-Remitting Multiple Sclerosis who are followed at the Neurology Outpatient Clinic of Kocaeli City Hospital. Participants will complete walking assessments under four conditions: single-task walking, dual-task walking, single-task obstacle crossing, and dual-task obstacle crossing. The dual-task condition will require participants to perform serial-3 subtraction while walking.

Clinical assessments including fatigue, walking limitation, cognition, health-related quality of life, and fear of movement will also be collected. The study aims to determine the association between obstacle crossing performance and fatigue and disability levels in individuals with RRMS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Dual-Task Cost During Obstacle Crossing

    Time frame: Baseline

    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.

Secondary outcomes

  1. Fatigue Severity Scale (FSS)

    Time frame: Baseline

    The Fatigue Severity Scale (FSS) is a nine-item questionnaire that evaluates the impact of fatigue on daily functioning. Each item is scored from 1 to 7, and the final score is the average of all items. Higher scores indicate greater fatigue severity.

  2. Modified Fatigue Impact Scale (MFIS)

    Time frame: Baseline

    The Modified Fatigue Impact Scale (MFIS) evaluates the impact of fatigue on physical, cognitive, and psychosocial functioning during the previous month. Higher total scores indicate greater fatigue impact.

  3. Multiple Sclerosis Walking Scale-12 (MSWS-12)

    Time frame: Baseline

    The Multiple Sclerosis Walking Scale-12 (MSWS-12) is a patient-reported outcome measure that evaluates the impact of multiple sclerosis on walking ability. Higher scores indicate greater walking limitation.

  4. Monitoring My Multiple Sclerosis Scale (MMMS)

    Time frame: Baseline

    The Monitoring My Multiple Sclerosis Scale (MMMS) evaluates physical status, relationships, energy, and cognitive or mental status. Higher scores indicate greater disease impact.

  5. Tampa Scale for Kinesiophobia (TSK)

    Time frame: Baseline

    The Tampa Scale for Kinesiophobia (TSK) is a 17-item questionnaire used to assess fear of movement. Total scores range from 17 to 68, with higher scores indicating greater kinesiophobia.

Study contacts

Contact information is provided by the study sponsor or research team.

Yunus Emre Kundakcı, Assoc. Prof.

CONTACT

[email protected]

+90 272 246 28 34|

Sponsors and collaborators

Lead sponsor

Afyonkarahisar Health Sciences University

Other

Registry information

Official study title

Relationship Between Single- and Dual-Task Obstacle Crossing Performance and Fatigue and Disability Levels in Patients With Relapsing-Remitting Multiple Sclerosis

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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