- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07631975
ROLE OF DUAL-TASK COST IN PREDICTING FALL RISK AMONG OLDER ADULTS RECEIVING INSTITUTIONAL CARE
ROLE OF DUAL-TASK COST IN PREDICTING FALL RISK IN OLDER ADULTS RECEIVING INSTITUTIONAL CARE: A CROSS-SECTIONAL CLASSIFICATION MODEL
Descripción general del estudio
Estado
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mine PEKESEN KURTÇA, ASISTANT PROFESSOR, PhD
- Número de teléfono: +903623121919
- Correo electrónico: mine.pekesenkurtca@omu.edu.tr
Ubicaciones de estudio
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Samsun, Turquía (Türkiye), 55270
- ONDOKUZ MAYIS UNIVERSITY, Samsun, Atakum 55270
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Contacto:
- MİNE PEKESEN P KURTÇA, PhD
- Número de teléfono: +903623121919
- Correo electrónico: mine.pekesenkurtca@omu.edu.tr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Being 65 years of age or older
- Residing in a nursing home or care institution for at least 1 month
- Ability to walk a distance of at least 10 meters
- Ability to ambulate independently with an assistive device (e.g., cane, walker), if needed
- Having a Montreal Cognitive Assessment (MoCA) score of 18 or above
- Ability to understand and execute single- and two-step verbal commands
- Voluntary agreement to participate in the study and providing informed consent
Exclusion Criteria:
- History of stroke or major orthopedic surgery within the past 6 monthsPresence of Parkinson's disease Stage ≥3 (Hoehn & Yahr) or any other neurological condition significantly affecting gait
- Having a MoCA score below 18
- History of fracture within the past 3 months
- Presence of severe pain affecting gait during test administration (Visual Analog Scale [VAS] ≥ 7)
- Uncontrolled hypertension (≥ 180/100 mmHg) or unstable cardiovascular status
- Active vestibular disease or a history of syncope within the past 3 months
- Visual or hearing impairment severe enough to impede test execution
- Inability to walk/ambulate without the physical assistance of another person
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Clinical Information Form
Periodo de tiempo: Single assessment (baseline)
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The following participant information will be recorded using a clinical information form developed by the researcher: Age (years) Sex (male/female) Educational status(illitirate/primare education/secondary education/high school or higher) Length of institutional stay( months and years) Height(cm) Weight(kg) Body mass index BMI (kg/m²) Number of chronic diseases and comorbidities Number of daily medications Use of assistive devices |
Single assessment (baseline)
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Fall Assesment
Periodo de tiempo: Single assessment (baseline)
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Fall history (Tripping, Slipping, Loss of Balance, Transposition) Fall History Questionnaire A fall will be defined as an event which results in an individual coming to rest inadvertently on the ground, floor, or a lower level. In this context, the following information will be recorded: Presence of a fall within the last 12 months (yes/no) Total number of falls within the last 12 months Presence of a fall within the last month (yes/no) Primary cause of the last fall Location of the last fall Injury status resulting from the last fall |
Single assessment (baseline)
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Montreal Cognitive Assessment (MoCA)
Periodo de tiempo: Single assessment (baseline)
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This assessment will be utilized to determine whether participants possess the cognitive competence to understand and execute the study protocol.
Individuals with a MoCA score below 18 will be excluded from the study.
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Single assessment (baseline)
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Timed Up and Go Test (TUG)
Periodo de tiempo: Single assessment (baseline)
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This test will be utilized to assess the functional mobility of the participants.
The participant will be instructed to rise from a standard-height chair, walk a distance of 3 meters, turn around, return to the chair, and sit back down.
The duration of the test will be recorded in seconds.
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Single assessment (baseline)
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Dual-task Timed Up and Go Test (TUG-DT)
Periodo de tiempo: Single assessment (baseline)
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This test will be administered to evaluate the dual-task performance of the participants. Participants will be instructed to simultaneously perform a cognitive task during the TUG test. Cognitive Task Animal naming will be utilized as the cognitive task under the dual-task condition. The participant will be asked to name as many animals as possible while walking. All participants will be assigned the same task, and standard verbal instructions will be utilized. |
Single assessment (baseline)
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Dual-Task Cost (DTC)
Periodo de tiempo: Single assessment (baseline)
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The dual-task cost will be calculated using the single-task TUG and dual-task TUG durations according to the following formula: DTC (%)"=(TUG_DT-TUG)/TUG×100 An increase in the DTC percentage will indicate greater performance degradation under the dual-task condition.
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Single assessment (baseline)
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Tinetti Performance-Oriented Mobility Assessment (POMA)
Periodo de tiempo: Single assessment (baseline)
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This assessment will be utilized to evaluate the balance and gait performance of the participants. The total Tinetti score will be used to determine the risk of falls. Operational Definition of Fall Risk Fall risk will be operationalized in two ways in the study: As a continuous variable: Total Tinetti score As a binary classification variable: Risk group based on the Tinetti score Classification based on the Tinetti score will be structured as follows: Low fall risk: 25-28 points Increased fall risk: 24 points and below This binary classification will be utilized for the classification model and ROC analysis. |
Single assessment (baseline)
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Falls Efficacy Scale-International (FES-I)
Periodo de tiempo: Single assessment (baseline)
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This scale will be utilized to assess the participants' level of fear of falling as a descriptive and secondary variable.
The FES-I score will not serve as a primary variable in the main model; however, it will be reported in descriptive analyses and secondary analyses as required.
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Single assessment (baseline)
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Colaboradores e Investigadores
Patrocinador
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
Otros números de identificación del estudio
- 2026/276
Plan de datos de participantes individuales (IPD)
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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.
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