- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07097779
- Original Trial
Helping Stroke Patients With Movement Using Photos, Videos, and Pictograms
A Comparison of Visual Aids for Stroke Rehabilitation: Photos, Videos, Pictograms
The goal of this interventional study is to learn how different types of visual aids-photos, videos, and pictograms-help people with stroke understand and perform simple physical movements. The researcher wants to find out which type of visual aid is most helpful and easiest to understand for stroke rehabilitation.
To take part, participants must be able to stand for at least one minute without help and understand simple instructions.
The main questions this study aims to answer are:
- Which type of visual aid (photo, video, or pictogram) helps participants perform movements more accurately?
- Which visual aid do participants find the easiest to understand and prefer?
- How much mental effort (cognitive load) do participants feel when using each type of visual aid?
- Do the effects of visual aids vary depending on stroke type, brain lesion location, or time since stroke?
The researcher will compare how each type of visual aid affects movement performance and participants' responses.
Participants will:
- View three types of visual aids (photo, video, pictogram) and perform specific physical tasks based on each.
- Have their movement performance recorded using a video camera.
- Complete a short survey after the tasks to rate their understanding, preferences, and cognitive effort.
- Take part in a single session that lasts about 20 minutes in a quiet room within the hospital.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Goyang-si, South Korea
- Ilsan Central Rehabilitation Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with stroke.
- Have sufficient vision and cognitive ability to perceive the provided visual materials (pictures or text).
- Able to stand independently without assistive devices for at least 1 minute.
- Have minimum cognitive ability necessary to understand tasks and follow instructions, with a score of 18 or higher on the Korean version of the Mini-Mental State Examination (K-MMSE).
Exclusion Criteria:
- ndividuals with other central nervous system disorders besides stroke that may affect motor performance or assessment.
- Individuals with musculoskeletal disorders, such as arthritis or fractures, that may affect motor performance or assessment.
- Individuals with severe visual impairments, such as visual field defects, unilateral neglect, or color blindness.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Visual Aids Intervention
|
Participants will be presented with three types of visual instructional aids: photographs, videos, and pictograms, via a laptop or tablet.
Each participant will perform three motor tasks, each paired with a different visual aid, assigned in random order using a Latin Square design.
Each task takes approximately 3 minutes, followed by 1 minute of rest.
After completing all tasks, participants will complete a 5-minute survey about their understanding, preference, and perceived cognitive load.
The total session lasts about 20 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor Task Performance Accuracy
Time Frame: Immediately after the experimental session
|
Motor task performance accuracy will be assessed using a checklist developed by the researchers, considering task characteristics and learning effects.
Each movement consists of 6 key performance elements, scored as 0 (not performed) or 1 (performed accurately), with a maximum of 6 points per task.
All performances will be video recorded, and three trained raters will independently score the recordings.
Inter-rater reliability will be evaluated using the Intraclass Correlation Coefficient (ICC) based on total scores.
|
Immediately after the experimental session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Hesitations
Time Frame: Immediately after the experimental session (video review)
|
The number of hesitations will be counted during motor task performance.
A hesitation is defined as a pause lasting more than 1 second, re-checking the visual aid, or modifying the movement.
This measure indirectly reflects the participant's movement fluency and level of cognitive certainty.
All performances will be video recorded and independently reviewed by three trained raters.
Inter-rater reliability will be assessed using the Intraclass Correlation Coefficient (ICC 3,k).
|
Immediately after the experimental session (video review)
|
|
Understanding of Visual Aids
Time Frame: Immediately after the experimental session
|
Participants will rate how helpful each type of visual aid (photo, video, pictogram) was for understanding the motor task.
A 5-point Likert scale will be used, where 1 indicates "Not helpful at all" and 5 indicates "Very helpful."
Participants will complete this rating immediately after completing each task.
|
Immediately after the experimental session
|
|
Preference for Visual Aids
Time Frame: Immediately after the experimental session
|
Participants will indicate which of the three visual instructional aids (photos, videos, pictograms) they found easiest to understand.
This measure captures participants' relative preference for the visual materials after performing the motor tasks.
|
Immediately after the experimental session
|
|
Number of Replays
Time Frame: During each task trial (approximately 3 minutes per task)
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The number of times the participant presses the replay button to review the visual instructional material before performing the task will be automatically recorded.
This measure will be stored using PsychoPy 2025.1.1 (Open Science Tools Ltd., Nottingham, UK).
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During each task trial (approximately 3 minutes per task)
|
|
Perceived Cognitive Load
Time Frame: Immediately after the experimental session
|
The degree of mental effort experienced by participants while performing the motor tasks with each type of visual instructional material will be assessed.
A pictorial 9-point Likert scale will be used, where a score of 1 indicates "not difficult at all" and a score of 9 indicates "very difficult"
|
Immediately after the experimental session
|
Collaborators and Investigators
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYU 2025-06-028-003
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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