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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07255352
Efecto de la aplicación del vendaje Kinesio en los músculos suprahioideos sobre la seguridad de la deglución en pacientes con disfagia postictus (Post-Stroke KT)
Investigación de los Efectos del Vendaje Kinesiológico Suprahioideo en la Seguridad de la Deglución y la Elevación Hiolaríngea en Pacientes con Disfagia Post-ictus
Dysphagia is defined as a disorder that occurs during the process of food transfer, beginning with oral intake and continuing until it reaches the stomach. The incidence of post-stroke dysphagia has been reported to range between 42% and 75%. Dysphagia can lead to aspiration pneumonia due to food entering the lungs, as well as malnutrition, dehydration, and even death. In patients with inadequate swallowing safety and efficiency, compensatory maneuvers such as chin tuck, head flexion, supraglottic swallowing, and the Mendelsohn maneuver are commonly used. These maneuvers aim to maintain oral intake by narrowing the laryngeal vestibule or increasing hyolaryngeal elevation. They are evaluated during videofluoroscopic swallowing studies and recommended to patients if they are found to prevent aspiration or penetration.
Kinesio taping (KT) has been reported to stimulate cutaneous receptors, increase sensory input, and facilitate neural reflexes, thereby promoting the activation of a greater number of motor units during maximal muscle contraction. In recent years, it has also begun to be used in the field of dysphagia rehabilitation. Studies conducted in stroke patients have shown that KT applied to the infrahyoid muscles provides resistance to the suprahyoid muscles and enhances their strength. A kinematic analysis study in stroke patients reported that KT applied to include the suprahyoid muscles increased vertical hyoid movement, although it did not result in a significant improvement in swallowing safety. The study, however, did not specify the detailed taping method used. Since the suprahyoid muscles are primarily responsible for hyolaryngeal elevation, KT focusing on this region has the potential to serve as a compensatory maneuver in dysphagia management.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Sanliurfa, Turquía (Türkiye)
- Harran University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosis of stroke
- Age over 18 years
- Presence of swallowing disorder symptoms
- Willingness to participate in the study
Exclusion Criteria:
- Presence of neurological diseases other than stroke
- Presence of tracheostomy
- Open wounds on the skin in the submental region
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Kinesio Taping Group
Participants with post-stroke dysphagia will receive Kinesio Taping applied to the suprahyoid muscle region. Swallowing safety and kinematic parameters will be evaluated before and after the intervention. |
Kinesio tape will be applied over the suprahyoid region to facilitate muscle activation. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Hyolaryngeal Kinematic Displacement (Hyoid and Laryngeal Displacement)
Periodo de tiempo: Immediately before and immediately after Kinesio taping application.
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Hyolaryngeal kinematic displacement will be assessed from videofluoroscopic swallowing study (VFSS) recordings using MATLAB-based STAMPS software. Anatomical landmarks (C2, C4, the subglottic air column, and the hyoid bone) will be digitized frame-by-frame to calculate hyoid and laryngeal displacement in the superior, anterior, and total (resultant) directions, yielding six kinematic parameters. Total displacement will be calculated as the square root of the sum of the squared anterior and superior displacement components. Spatial calibration will be performed using a 20 mm reference object placed on the mastoid process. Differences in these parameters between taped and non-taped swallowing trials will be analyzed to assess the acute effect of suprahyoid Kinesio taping on hyolaryngeal movement. |
Immediately before and immediately after Kinesio taping application.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Swallowing Safety (Penetration-Aspiration Scale Score)
Periodo de tiempo: Immediately before and immediately after Kinesio taping application.
|
Swallowing safety will be evaluated using the Penetration-Aspiration Scale (PAS) during videofluoroscopic swallowing study (VFSS). Each swallow will be scored on an 8-point scale, with higher scores indicating a higher risk of airway invasion. The difference in PAS scores before and immediately after Kinesio taping will be analyzed to assess the acute effect of the intervention on swallowing safety. |
Immediately before and immediately after Kinesio taping application.
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades esofágicas
- Enfermedades Otorrinolaringológicas
- Enfermedades faríngeas
- Carrera
- Trastornos de la deglución
Otros números de identificación del estudio
- HRÜ/24.14.41
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.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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