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

July 13, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Semiotically-Optimized Video Education
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.
Behavioral: Standard Video Education
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiamen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yang Liu, PhD, Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

No

Studies a U.S. FDA-regulated device product

No

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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