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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yunus Emre Kundakcı, Assoc. Prof.
- Número de teléfono: +90 272 246 28 34|
- Correo electrónico: y.emre.kndkc@gmail.com
Ubicaciones de estudio
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Merkez
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Afyonkarahisar, Merkez, Turquía (Türkiye), 03000
- Reclutamiento
- Afyonkarahisar Health Sciences University
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Contacto:
- Yunus E Kundakcı, Assoc. Prof.
- Número de teléfono: +905078638878
- Correo electrónico: y.emre.kndkc@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Dual-Task Cost During Obstacle Crossing
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Tampa Scale for Kinesiophobia (TSK)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Esclerosis múltiple
- Fatiga
Otros números de identificación del estudio
- 2026/2-122
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .