- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Yunus Emre Kundakcı, Assoc. Prof.
- Telefonnummer: +90 272 246 28 34|
- E-post: y.emre.kndkc@gmail.com
Studieorter
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Merkez
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Afyonkarahisar, Merkez, Turkiet (Türkiye), 03000
- Rekrytering
- Afyonkarahisar Health Sciences University
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Kontakt:
- Yunus E Kundakcı, Assoc. Prof.
- Telefonnummer: +905078638878
- E-post: y.emre.kndkc@gmail.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Dual-Task Cost During Obstacle Crossing
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Tampa Scale for Kinesiophobia (TSK)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026/2-122
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