- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Yunus Emre Kundakcı, Assoc. Prof.
- Telefonnummer: +90 272 246 28 34|
- E-mail: y.emre.kndkc@gmail.com
Studiesteder
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Merkez
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Afyonkarahisar, Merkez, Tyrkiet (Türkiye), 03000
- Rekruttering
- Afyonkarahisar Health Sciences University
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Kontakt:
- Yunus E Kundakcı, Assoc. Prof.
- Telefonnummer: +905078638878
- E-mail: y.emre.kndkc@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Dual-Task Cost During Obstacle Crossing
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Tampa Scale for Kinesiophobia (TSK)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026/2-122
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