- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Jilin
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Siping, Jilin, Cina, 136000
- Siping Central People's Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Activities of Daily Living (ADL)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Sleep Quality
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Yang Liu, PhD, Xiamen University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SOVE-2023-001
- XMSHLXH2320 (Altro numero di sovvenzione/finanziamento: Xiamen Nursing Association)
- 2024038 (Altro numero di sovvenzione/finanziamento: Siping City Science and Technology Development Plan)
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