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Relationship Between Single- and Dual-Task Obstacle Crossing Performance and Fatigue and Disability in Multiple Sclerosis

30 de julio de 2026 actualizado por: Yunus Emre Kundakçı, Afyonkarahisar Health Sciences University

Relationship Between Single- and Dual-Task Obstacle Crossing Performance and Fatigue and Disability Levels in Patients With Relapsing-Remitting Multiple Sclerosis

This cross-sectional observational study aims to investigate the relationship between obstacle crossing performance under single-task and dual-task conditions and the levels of fatigue and disability in individuals with Relapsing-Remitting Multiple Sclerosis (RRMS). Walking performance will be assessed under standard walking and obstacle crossing conditions with and without a concurrent cognitive task. The study will examine how increased task complexity affects walking performance and its association with fatigue, disability, cognition, and functional mobility.

Descripción general del estudio

Estado

Reclutamiento

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

De observación

Inscripción (Estimado)

30

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

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

    • Merkez
      • Afyonkarahisar, Merkez, Turquía (Türkiye), 03000
        • Reclutamiento
        • Afyonkarahisar Health Sciences University
        • Contacto:
          • Yunus E Kundakcı, Assoc. Prof.
          • Número de teléfono: +905078638878
          • Correo electrónico: y.emre.kndkc@gmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

Adults aged 18 to 65 years with Relapsing-Remitting Multiple Sclerosis who are followed at the Neurology Outpatient Clinic of Kocaeli City Hospital, have an EDSS score between 0 and 6, are clinically stable, and meet all eligibility criteria.

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Dual-Task Cost During Obstacle Crossing
Periodo de tiempo: Baseline
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.
Baseline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Tampa Scale for Kinesiophobia (TSK)
Periodo de tiempo: Baseline
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.
Baseline
The Modified Fatigue Impact Scale (MFIS)
Periodo de tiempo: Baseline
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
Baseline
Multiple Sclerosis Walking Scale-12 (MSWS-12)
Periodo de tiempo: Baseline
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.
Baseline
Monitoring My Multiple Sclerosis Scale (MMMS)
Periodo de tiempo: Baseline
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.
Baseline
Fatigue Severity Scale (FSS)
Periodo de tiempo: Baseline
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.
Baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

20 de marzo de 2026

Finalización primaria (Actual)

25 de julio de 2026

Finalización del estudio (Estimado)

20 de febrero de 2027

Fechas de registro del estudio

Enviado por primera vez

26 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

26 de julio de 2026

Publicado por primera vez (Actual)

30 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

31 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de julio de 2026

Última verificación

1 de febrero de 2026

Más información

Términos relacionados con este estudio

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.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .