- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07736482
Relationship Between Single- and Dual-Task Obstacle Crossing Performance and Fatigue and Disability in Multiple Sclerosis
Relationship Between Single- and Dual-Task Obstacle Crossing Performance and Fatigue and Disability Levels in Patients With Relapsing-Remitting Multiple Sclerosis
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yunus Emre Kundakcı, Assoc. Prof.
- Phone Number: +90 272 246 28 34|
- Email: y.emre.kndkc@gmail.com
Study Locations
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Merkez
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Afyonkarahisar, Merkez, Turkey (Türkiye), 03000
- Recruiting
- Afyonkarahisar Health Sciences University
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Contact:
- Yunus E Kundakcı, Assoc. Prof.
- Phone Number: +905078638878
- Email: y.emre.kndkc@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Dual-Task Cost During Obstacle Crossing
Time Frame: Baseline
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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.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Tampa Scale for Kinesiophobia (TSK)
Time Frame: Baseline
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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.
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Baseline
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The Modified Fatigue Impact Scale (MFIS)
Time Frame: Baseline
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The Modified Fatigue Impact Scale (MFIS) evaluates the impact of fatigue on physical, cognitive, and psychosocial functioning during the previous month.
Total scores range from 0 to 84, with higher scores indicating greater fatigue impact
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Baseline
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Multiple Sclerosis Walking Scale-12 (MSWS-12)
Time Frame: Baseline
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The Multiple Sclerosis Walking Scale-12 is a patient-reported outcome measure that evaluates the impact of multiple sclerosis on walking ability.
Raw total scores range from 12 to 60, with higher scores indicating greater walking limitation.
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Baseline
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Monitoring My Multiple Sclerosis Scale (MMMS)
Time Frame: Baseline
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The Monitoring My Multiple Sclerosis Scale (MMMS) evaluates physical status, relationships, energy, and cognitive or mental status.
Total scores range from 26 to 104, with higher scores indicating better health status and functioning.
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Baseline
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Fatigue Severity Scale (FSS)
Time Frame: Baseline
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The Fatigue Severity Scale (FSS) assesses the severity of fatigue and its impact on daily functioning.
It consists of 9 items scored from 1 to 7. The total score is calculated as the mean of the 9 items, ranging from 1 to 7, with higher scores indicating greater fatigue severity.
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Baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/2-122
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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