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Effect of a Semiotically-Optimized Video Education Model on Post-Stroke Rehabilitation (SOVE-Stroke)

13 de julio de 2026 actualizado por: Longfei Tao, Xiamen University

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

Stroke is a leading cause of death and disability worldwide. Many stroke survivors face difficulties with daily activities, sleep problems, anxiety, and depression during recovery. Health education videos can help patients learn about rehabilitation, but standard videos often contain too much information and are hard for patients to follow. This study aims to test whether using semiotics - the science of signs and symbols - to redesign health education videos can help stroke patients better comprehend and apply rehabilitation instructions. The study is designed to include 200 stroke patients at Siping Central Hospital in Jilin Province, China. Patients will be randomly assigned to either the semiotic-optimized video group or the standard health education video group. Outcome measures, including activities of daily living, sleep quality, anxiety, depression, and satisfaction with care, will be assessed before and after the intervention to evaluate the effectiveness of the optimized video education model.

Descripción general del estudio

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

Intervencionista

Inscripción (Actual)

200

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Jilin
      • Siping, Jilin, Porcelana, 136000
        • Siping Central People's Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Imaging-confirmed cerebral infarction per 2019 Chinese Guidelines
  2. Age ≥18 years
  3. Stable condition during rehabilitation phase
  4. Alert, able to comprehend and operate video playback
  5. Signed informed consent

Exclusion Criteria:

  1. Incomplete records, inaccurate data, or failure to complete the intervention

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
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.
Participants received semiotically-optimized video-based health education, 28 days, twice daily, 5-8 minutes per session, including music and video feedback.
Comparador activo: Active Comparator: Standard Video Group
Participants received standard video-based health education, 28 days, routine rehabilitation instructional videos and assistive device guidance.
Participants received standard video-based health education, 28 days, routine rehabilitation instructional videos and assistive device guidance.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Activities of Daily Living (ADL)
Periodo de tiempo: Baseline and Day 28
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.
Baseline and Day 28

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Sleep Quality
Periodo de tiempo: Baseline and Day 28
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.
Baseline and Day 28
Change in Anxiety
Periodo de tiempo: Baseline and Day 28
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.
Baseline and Day 28
Change in Depression
Periodo de tiempo: Baseline and Day 28
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.
Baseline and Day 28
Patient Satisfaction
Periodo de tiempo: Day 28
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.
Day 28

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Yang Liu, PhD, Xiamen University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de enero de 2023

Finalización primaria (Actual)

31 de diciembre de 2023

Finalización del estudio (Actual)

31 de diciembre de 2023

Fechas de registro del estudio

Enviado por primera vez

8 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

13 de julio de 2026

Publicado por primera vez (Actual)

17 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

13 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

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.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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