- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07847827
Fear of Falling in Stroke: Its Relationship With Motor Recovery, Stroke Duration, Trunk Control, and Balance
Factors Associated With Fear of Falling in Stroke
The aim of this study is to evaluate the relationship between fear of falling and motor recovery, stroke duration, trunk control, and balance in stroke patients.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Fear of falling is a common and disabling complication in stroke patients during the acute, subacute, and chronic stages. This observational study aims to evaluate the relationship between fear of falling and upper/lower extremity motor recovery, time since stroke, trunk control, and balance in post-stroke individuals. The investigators will assess participants using demographic information, fall history, the Montreal Cognitive Assessment, Brunnstrom Staging for upper and lower extremity motor recovery, the Falls Efficacy Scale International, the Trunk Impairment Scale, and the Tinetti Performance Oriented Mobility Assessment. Additionally, the investigators will evaluate whether clinical parameters such as motor recovery, balance and trunk control correlate with the level of fear of falling.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lütfiye AKKURT, Assistant Professor
- Número de teléfono: 1446 0 (274) 260 00 43
- Correo electrónico: lutfiye.akkurt@ksbu.edu.tr
Copia de seguridad de contactos de estudio
- Nombre: Lütfiye AKKURT, PT, PhD, Assistant Professor
- Número de teléfono: 1446 0 (274) 260 00 43
- Correo electrónico: lutfiye.akkurt@ksbu.edu.tr
Ubicaciones de estudio
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Kütahya, Turquía (Türkiye), 43100
- Kütahya Health Sciences University
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Contacto:
- Lütfiye AKKURT, PT, PhD, Assistant Professor
- Número de teléfono: 1446 +90 (274) 260 00 43
- Correo electrónico: lutfiye.akkurt@ksbu.edu.tr
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Kütahya
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Kütahya, Kütahya, Turquía (Türkiye), (552) 266-8356
- Kütahya City Hospital Yoncalı Physical Therapy and Rehabilitation Location
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Stroke patients
Descripción
Inclusion Criteria:
- Having a diagnosis of stroke
- Aged ≥ 18 years old
- History of at least one fall
- Ability to walk 10 meters independently or with an assistive device
- Ability to understand and follow simple instructions
Exclusion Criteria:
- Having another neurological disease (except for stroke)
- Having a surgery upper or lower extremity in the last 6 months
- Unwillingness to participate
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: OTHER
- Perspectivas temporales: CROSS_SECTIONAL
Cohortes e Intervenciones
Grupo / Cohorte |
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Post-stroke patients
Individuals aged 18 and older diagnosed with stroke, who have a history of at least one fall, are able to walk 10 meters independently or with an assistive device, and can understand and follow simple instructions. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Montreal Cognitive Assessment (MoCA)
Periodo de tiempo: Baseline
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The Montreal Cognitive Assessment (MoCA) is a 30-point scale comprising 16 items across 11 categories used to screen for cognitive impairment in stroke and other neurological conditions, where a score of 26 or above indicates normal cognitive function. |
Baseline
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Brunnstrom Recovery Stages of Upper and Lower Extremity
Periodo de tiempo: Baseline
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The Brunnstrom recovery stages are a staging system that shows the motor recovery in patients with stroke. The Brunnstrom Recovery Stages of Upper and Lower Extremity of six stages. Higher stages indicate better motor function. |
Baseline
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Falls Efficacy Scale-International (FES-I)
Periodo de tiempo: Baseline
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The Falls Efficacy Scale-International (FES-I) is a short, easy to administer tool that measures the level of concern about falling during 16 social and physical activities inside and outside the home whether or not the person actually does the activity. The level of concern is measured on a four-point Likert scale (1=not at all concerned to 4=very concerned). Total score is between 16 and 64 points. Lower scores mean a better outcome. |
Baseline
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Trunk Impairment Scale (TIS)
Periodo de tiempo: Baseline
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The Trunk Impairment Scale (TIS) evaluates post-stroke trunk control across three subscales (static sitting balance, dynamic sitting balance, and coordination) with a maximum total score of 23, where higher scores reflect better trunk function. |
Baseline
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Tinetti Performance Oriented Mobility Assessment (POMA) - Balance
Periodo de tiempo: Baseline
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The Tinetti Performance Oriented Mobility Assessment (POMA) balance subscale comprises 9 items with a total score of 16, where higher scores indicate better balance performance. |
Baseline
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mine PEKESEN KURTÇA, PT, PhD, Assistant Professor, Ondokuz Mayıs University
- Investigador principal: Seda Nur KEMER, PT, PhD, Lecturer, Ondokuz Mayıs University
- Investigador principal: Barış YENEN, MD, Assistant Professor, Kütahya Health Sciences University
- Investigador principal: Mustafa ÇETİNER, MD, Associate Professor, Kütahya Health Sciences University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
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
Otros números de identificación del estudio
- 2026/10-51
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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