- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07656844
Motor Imagery in Post-Stroke Dysphagia (MI-PSD)
The Effect of Motor Imagery on Swallowing Functions in Patients With Post-Stroke Dysphagia: A Single-Blind Randomized Controlled Study
This study evaluated the effects of motor imagery added to conventional swallowing rehabilitation in patients with dysphagia after stroke. Dysphagia, or swallowing difficulty, is a common problem after stroke and may increase the risk of aspiration, pneumonia, malnutrition, dehydration, and reduced quality of life.
Participants with post-stroke dysphagia were randomly assigned to one of three groups: video-assisted motor imagery, motor imagery alone, or control. All participants received conventional swallowing rehabilitation. In addition, the video-assisted motor imagery group watched videos showing swallowing-related actions and then mentally imagined the observed movement. The motor imagery alone group performed mental imagery of swallowing without visual stimulation. The control group received only conventional swallowing rehabilitation.
The intervention period lasted 4 weeks, with sessions performed twice weekly. Swallowing function was assessed before and after treatment using the Gugging Swallowing Screen, the Penetration-Aspiration Scale based on videofluoroscopic swallowing study, and the Stroke Impact Scale.
The aim of the study was to determine whether motor imagery, especially when supported by video observation, provides additional benefit for swallowing recovery in patients with post-stroke dysphagia.
Descripción general del estudio
Estado
Descripción detallada
This single-blind randomized controlled study was conducted in patients with post-stroke oropharyngeal dysphagia receiving inpatient rehabilitation. The study aimed to evaluate whether motor imagery added to conventional dysphagia rehabilitation improves swallowing function, and whether video-assisted motor imagery provides additional benefit compared with motor imagery alone.
Participants were randomly assigned to one of three groups. The video-assisted motor imagery group received conventional dysphagia rehabilitation plus video-assisted motor imagery. In this group, patients watched videos showing swallowing-related actions and then mentally simulated the observed swallowing movement. The motor imagery alone group received conventional dysphagia rehabilitation plus motor imagery training without visual stimulation. The control group received only conventional dysphagia rehabilitation.
The intervention was administered twice weekly for 4 weeks. Swallowing function was assessed before and after treatment using clinical and instrumental outcome measures, including the Gugging Swallowing Screen and the Penetration-Aspiration Scale based on videofluoroscopic swallowing study. Stroke-related functional impact and quality of life were evaluated using the Stroke Impact Scale.
The study was designed to determine whether motor imagery is a feasible adjunctive rehabilitation approach for improving swallowing safety and swallowing-related outcomes in patients with post-stroke dysphagia.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ankara
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Ankara, Ankara, Turquía (Türkiye), 06170
- Ankara Etlik City Hospital, Physical Medicine and Rehabilitation Clinic
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 18 years or older
- Diagnosis of stroke by a neurologist based on medical history, physical examination, and brain computed tomography and/or magnetic resonance imaging findings
- No progressive or non-progressive neurological disease other than stroke
- No known psychiatric disease
- No sensory dysfunction
- No communication problem
- Mini-Mental State Examination score of 24 or higher and ability to follow commands at a level sufficient to comply with motor imagery practice
- Ability to maintain sitting balance and remain in a sitting position for 30 minutes
- Presence of dysphagia symptoms or need for further evaluation based on dysphagia screening tests, with referral for videofluoroscopic swallowing study
- No serious acute medical condition such as hemodynamic instability during testing
Exclusion Criteria:
- Refusal to participate in the study or withdrawal from the study during the study period
- Inadequate performance of videofluoroscopic swallowing evaluation due to technical, clinical, or patient compliance-related reasons
- Presence of sensory-motor aphasia
- Presence of visual or hearing impairment
- Presence of severe neglect
- Evidence of esophageal dysphagia on videofluoroscopy and/or clinical symptoms
- History of surgery, cancer, or radiotherapy in the head and neck region that may affect swallowing
- Presence of vertebral problems that may restrict cervical movement, such as advanced cervical discopathy, prominent osteophyte formation, or cervical deformity
- Presence of neurological diseases other than stroke that may cause dysphagia, such as dementia, Parkinson disease, multiple sclerosis, or neuromuscular disease
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Video-Assisted Motor Imagery Group
Participants in this group received conventional dysphagia rehabilitation plus video-assisted motor imagery.
They watched videos depicting swallowing-related actions and then mentally simulated the observed swallowing movement.
The intervention was administered twice weekly for 4 weeks.
|
Participants watched videos showing swallowing-related actions and then performed motor imagery by mentally simulating the observed swallowing movement.
This intervention was added to conventional dysphagia rehabilitation.
Conventional dysphagia rehabilitation included standard swallowing therapy approaches used in clinical practice, such as swallowing exercises, compensatory strategies, postural adjustments, and diet or consistency modifications when appropriate.
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|
Experimental: Motor Imagery Alone Group
Participants in this group received conventional dysphagia rehabilitation plus motor imagery training without visual stimulation.
They were instructed to mentally imagine the swallowing movement.
The intervention was administered twice weekly for 4 weeks.
|
Conventional dysphagia rehabilitation included standard swallowing therapy approaches used in clinical practice, such as swallowing exercises, compensatory strategies, postural adjustments, and diet or consistency modifications when appropriate.
Participants performed mental imagery of swallowing without visual stimulation.
This intervention was added to conventional dysphagia rehabilitation.
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Comparador activo: Control Group
Participants in this group received conventional dysphagia rehabilitation alone.
The rehabilitation program was administered twice weekly for 4 weeks.
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Conventional dysphagia rehabilitation included standard swallowing therapy approaches used in clinical practice, such as swallowing exercises, compensatory strategies, postural adjustments, and diet or consistency modifications when appropriate.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Penetration-Aspiration Scale Score
Periodo de tiempo: Baseline and after 4 weeks of intervention
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Change in swallowing safety was assessed using the Penetration-Aspiration Scale based on videofluoroscopic swallowing study.
The scale evaluates airway invasion during swallowing.
Scores range from 1 to 8, with higher scores indicating greater penetration or aspiration severity.
A decrease in score indicates improvement.
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Baseline and after 4 weeks of intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Gugging Swallowing Screen Score
Periodo de tiempo: Baseline and after 4 weeks of intervention
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Change in swallowing function was assessed using the Gugging Swallowing Screen.
The scale evaluates dysphagia severity and aspiration risk.
Scores range from 0 to 20, with higher scores indicating better swallowing function and lower dysphagia severity.
An increase in score indicates improvement.
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Baseline and after 4 weeks of intervention
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Change in Stroke Impact Scale Score
Periodo de tiempo: Baseline and after 4 weeks of intervention
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Change in stroke-related functional impact and quality of life was assessed using the Stroke Impact Scale.
Higher scores indicate better stroke-related function and quality of life.
An increase in score indicates improvement.
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Baseline and after 4 weeks of intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gizem Karcı Aktekin, MD, Ankara Etlik City Hospital, Physical Medicine and Rehabilitation Clinic
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
- Motor Imagery
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
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