- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Yunus Emre Kundakcı, Assoc. Prof.
- Numéro de téléphone: +90 272 246 28 34|
- E-mail: y.emre.kndkc@gmail.com
Lieux d'étude
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Merkez
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Afyonkarahisar, Merkez, Turquie (Türkiye), 03000
- Recrutement
- Afyonkarahisar Health Sciences University
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Contact:
- Yunus E Kundakcı, Assoc. Prof.
- Numéro de téléphone: +905078638878
- E-mail: y.emre.kndkc@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Dual-Task Cost During Obstacle Crossing
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Tampa Scale for Kinesiophobia (TSK)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026/2-122
Informations sur les médicaments et les dispositifs, documents d'étude
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