- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07709806
Effect of a Semiotically-Optimized Video Education Model on Post-Stroke Rehabilitation (SOVE-Stroke)
A Randomized Controlled Trial Evaluating the Effect of a Semiotically-Optimized Video Education Model on Activities of Daily Living, Sleep Quality, Anxiety, Depression, and Patient Satisfaction in Post-Stroke Rehabilitation Patients
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Stroke rehabilitation requires patients to acquire and retain complex self-care knowledge, yet cognitive impairments following stroke often limit their ability to process standard verbal and written health education. Conventional video-based education, while beneficial, frequently presents information in ways that overlook patients' cognitive load and perceptual limitations. Semiotic theory - the systematic study of how signs, symbols, and multimodal cues construct meaning - offers a framework for redesigning educational content to enhance comprehension, retention, and behavioral adoption.
This is a randomized controlled trial conducted at the Rehabilitation Department of Siping Central Hospital, with the intervention period scheduled from January to December 2023. The intervention was developed by a multidisciplinary team of eight specialists and nurses from the Rehabilitation and Neurology Departments. Twenty-two educational videos were produced across three domains: rehabilitation science, exercise guidance, and dietary advice. Each video averaged five to eight minutes in duration. In the experimental group, videos were redesigned using semiotic principles: key rehabilitation actions were highlighted through local magnification with bold, red subtitles and auditory cues; incorrect postures were filmed and contrasted with correct demonstrations using comparative visual cues; and a curated music library was integrated to support relaxation and sleep. Video feedback techniques were also employed, including on-site assessment of movement accuracy and post-training questioning to evaluate knowledge retention. The intervention was delivered twice daily under nursing supervision throughout the 28-day inpatient rehabilitation period.
The control group received standard care with the same set of rehabilitation videos delivered through routine face-to-face guidance, without semiotic optimization or structured video feedback. The primary objective is to evaluate whether the semiotically-optimized video education model can improve activities of daily living compared to standard video education. Secondary objectives will assess changes in sleep quality, anxiety, depression, and patient satisfaction.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Jilin
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Siping, Jilin, Porcelana, 136000
- Siping Central People's Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Imaging-confirmed cerebral infarction per 2019 Chinese Guidelines
- Age ≥18 years
- Stable condition during rehabilitation phase
- Alert, able to comprehend and operate video playback
- Signed informed consent
Exclusion Criteria:
- Incomplete records, inaccurate data, or failure to complete the intervention
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Experimental: Semiotically-Optimized Video Group
Participants received semiotically-optimized video-based health education, 28 days, twice daily, 5-8 minutes per session, including music and video feedback.
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Participants received semiotically-optimized video-based health education, 28 days, twice daily, 5-8 minutes per session, including music and video feedback.
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Comparador activo: Active Comparator: Standard Video Group
Participants received standard video-based health education, 28 days, routine rehabilitation instructional videos and assistive device guidance.
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Participants received standard video-based health education, 28 days, routine rehabilitation instructional videos and assistive device guidance.
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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 Activities of Daily Living (ADL)
Periodo de tiempo: Baseline and Day 28
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Modified Barthel Index (MBI), The MBI comprises 10 items assessing ADL, with a total score ranging from 0 to 100.
Higher scores indicate better independence in daily living activities.
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Baseline and Day 28
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Sleep Quality
Periodo de tiempo: Baseline and Day 28
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Pittsburgh Sleep Quality Index (PSQI), The PSQI consists of 18 items assessing sleep quality over a one-month interval.
The global score ranges from 0 to 21. Lower scores indicate better sleep quality, whereas higher scores indicate worse sleep quality.
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Baseline and Day 28
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Change in Anxiety
Periodo de tiempo: Baseline and Day 28
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Beck Anxiety Inventory (BAI), The BAI consists of 21 self-report items, with a total score ranging from 0 to 63.
Higher scores indicate more severe anxiety.
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Baseline and Day 28
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Change in Depression
Periodo de tiempo: Baseline and Day 28
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Chinese Version of the Beck Depression Inventory, 2nd edition (BDI-Ⅱ-C), The BDI-II-C consists of 21 items assessing depressive symptoms, with a total score ranging from 0 to 63.
Higher scores indicate more severe depression.
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Baseline and Day 28
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Patient Satisfaction
Periodo de tiempo: Day 28
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Self-developed Inpatient Satisfaction Questionnaire, The questionnaire consists of 10 items rated on a 5-point Likert scale, yielding a total score ranging from 10 to 50.
Higher scores indicate better patient satisfaction.
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Day 28
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yang Liu, PhD, Xiamen University
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
Otros números de identificación del estudio
- SOVE-2023-001
- XMSHLXH2320 (Otro número de subvención/financiamiento: Xiamen Nursing Association)
- 2024038 (Otro número de subvención/financiamiento: Siping City Science and Technology Development Plan)
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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