- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Jilin
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Siping, Jilin, China, 136000
- Siping Central People's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Activities of Daily Living (ADL)
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Sleep Quality
Time Frame: 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
Time Frame: 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.
|
Baseline and Day 28
|
|
Change in Depression
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yang Liu, PhD, Xiamen University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOVE-2023-001
- XMSHLXH2320 (Other Grant/Funding Number: Xiamen Nursing Association)
- 2024038 (Other Grant/Funding Number: Siping City Science and Technology Development Plan)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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