Improving Dysphagia in Stroke Patients With Chin Tuck Against Resistance Exercise
According to a 2014 report from the Ministry of Health and Welfare, cerebrovascular disease is one of the leading causes of death, with a mortality rate of 51.6 per 100,000 population, ranking fourth among the top ten causes of death. Stroke is often associated with symptoms such as unilateral weakness, slurred speech, facial asymmetry, and swallowing or speech difficulties, with approximately 42-67% of patients experiencing dysphagia.
Dysphagia is primarily associated with dysfunction of the pharyngeal muscles and impaired coordination, often accompanied by central nervous system dysfunction. Common symptoms include choking, coughing after eating, drooling, difficulty eating, and swallowing problems, which may lead to complications such as pneumonia and malnutrition.
Chin tuck against resistance (CTAR), developed by Yoon et al. in 2014, is a simple and non-invasive exercise aimed at improving pharyngeal muscle contraction, chewing and bolus formation, and coordination between the pharynx and upper esophagus. Previous studies suggest that CTAR exercises can effectively improve swallowing-related muscle function.
However, there is a lack of research targeting acute stroke patients in hospital settings. Therefore, this study is designed as a randomized controlled trial (RCT) to evaluate the effectiveness of CTAR exercises in improving dysphagia.
Participants will be randomly assigned to an experimental group or a control group. The experimental group will perform CTAR exercises once daily, five days per week, for two weeks, in addition to routine rehabilitation exercises until discharge. The control group will receive routine rehabilitation exercises once daily, five days per week.
Effectiveness will be assessed using a 90 mL water swallowing test and the Eating Assessment Tool-10 (EAT-10). Baseline measurements will be conducted prior to the intervention, and subsequent assessments will be performed every two days during the study period. Additional outcomes include changes in EAT-10 scores and the removal rate of nasogastric tubes before discharge.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
According to a 2014 report from the Ministry of Health and Welfare, cerebrovascular disease is one of the leading causes of death, with a mortality rate of 51.6 per 100,000 population, ranking fourth among the top ten causes of death. Stroke is commonly associated with neurological deficits such as hemiparesis, dysarthria, facial asymmetry, and dysphagia. Approximately 42-67% of stroke patients experience swallowing difficulties.
Dysphagia in stroke patients is primarily related to dysfunction of pharyngeal muscles and impaired coordination of the swallowing mechanism, often accompanied by central nervous system impairment. Common clinical manifestations include choking, coughing during or after meals, drooling, difficulty chewing and swallowing, which may lead to serious complications such as aspiration pneumonia and malnutrition.
Chin tuck against resistance (CTAR), first introduced by Yoon et al. in 2014, is a simple and non-invasive exercise designed to strengthen suprahyoid muscles, improve pharyngeal contraction, enhance bolus control, and facilitate coordination between the pharynx and upper esophageal sphincter. Previous studies have demonstrated that CTAR exercise can effectively improve swallowing-related muscle function.
However, there remains a lack of evidence focusing on acute stroke patients in hospital settings. Therefore, this study is designed as a randomized controlled trial (RCT) to evaluate the effectiveness of CTAR exercise in improving dysphagia among hospitalized stroke patients.
Participants will be randomly assigned to an experimental group or a control group. The experimental group will perform CTAR exercise once daily, five days per week, for two consecutive weeks, in addition to routine rehabilitation. The control group will receive routine rehabilitation alone at the same frequency.
Swallowing function will be evaluated using a 90 mL water swallowing test and the Eating Assessment Tool-10 (EAT-10). Baseline assessments will be conducted prior to intervention, followed by repeated measurements every two days during the study period. Additional outcomes include changes in EAT-10 scores and the rate of nasogastric tube removal before discharge.
This study aims to determine whether CTAR exercise provides additional benefits over conventional rehabilitation in improving swallowing function in stroke patients, and to provide evidence for clinical rehabilitation practice.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Taichung, Taiwán, 407
- Taichung Veterans General Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients aged ≥ 20 years diagnosed with ischemic stroke
- NIH Stroke Scale (NIHSS) score between 6 and 20
- Conscious and able to communicate in Mandarin or Taiwanese
- Failed the 90 mL water swallow test
Exclusion Criteria:
- Cognitive impairment
- Brainstem stroke or intracerebral hemorrhage
- Diagnosed psychiatric disorder or dementia
- Unstable vital signs
- Presence of endotracheal tube or tracheostomy
- History of cervical spine injury
- Head-of-bed elevation restricted to less than 30 degrees
- Nil per os (NPO) status as ordered by a physician
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Experimental Group
Participants receive routine rehabilitation plus chin tuck against resistance (CTAR) exercise.
|
Participants perform chin tuck against resistance (CTAR) exercise once daily, five days per week, for two consecutive weeks.
The exercise is conducted in addition to routine rehabilitation therapy to improve swallowing function.
Participants receive routine rehabilitation therapy once daily, five days per week, for two consecutive weeks.
|
|
Comparador activo: Control Group
Participants receive routine rehabilitation therapy only.
|
Participants receive routine rehabilitation therapy once daily, five days per week, for two consecutive weeks.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Swallowing function assessed by 90 mL water swallowing test
Periodo de tiempo: Baseline and every 2 days during the 2-week intervention period
|
Swallowing function is evaluated using a 90 mL water swallowing test.
Participants are assessed at baseline and every 2 days during the intervention period.
The outcome is recorded as pass or fail to determine improvement in swallowing ability.
|
Baseline and every 2 days during the 2-week intervention period
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Swallowing-related quality of life assessed by EAT-10
Periodo de tiempo: Baseline and once weekly during the 2-week intervention period
|
The total score ranges from 0 to 40, with higher scores indicating more severe dysphagia symptoms.
A score of 3 or higher is considered indicative of a risk of dysphagia
|
Baseline and once weekly during the 2-week intervention period
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hsiao-Chi Nieh, Nursing Supervisor, Taichung Veterans General Hospital
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
- CF24234C
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
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. .