- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05016492
Interactive Digital Game for Improving Visual Perceptual Defects in Children With Developmental Disability
August 17, 2021 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
Interactive Digital Game for Improving Visual Perceptual Defects in Children With Developmental Disability: Evaluation of Efficacy and User Satisfaction
Visual perceptual defects in children can negatively affect their activities of daily living.The aims of this study were to develop and evaluate an interactive digital game system for correcting visual perceptual defects and to evaluate the effectiveness of the proposed system.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- 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
-
-
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Kaohsiung, Taiwan, 80708
- Kaohsiung Medical University
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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
Ages Eligible for Study
4 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Record of developmental disability diagnosis
- Ability to understand instructions
- TVPS-3 score lower than 25% of the norm reference and diagnosis of visual perceptual defect
- Test of Nonverbal Intelligence-3rd Edition score higher than 70
Exclusion Criteria:
- Did not follow or understand the instructions for participating in the study
- Had severe defects in vision, hearing, etc.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Digital game group
The digital game group received the standard 4-week course of rehabilitation but with an additional 30-min interactive digital game training session per week.
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Subjects received 30-min interactive digital game training session per week.
The game system contain 7 skills training, each of which was named according to the corresponding TVPS-3.
Subjects received the standard 4-week course of rehabilitation delivered in one 30-min session per week.
The course of rehabilitation included: sensory integration therapy, cognitive function training and visual perception/auditory attention training.
|
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Active Comparator: Standard rehab group
The standard rehab group received the standard 4-week course of rehabilitation delivered in one 30-min session per week.
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Subjects received the standard 4-week course of rehabilitation delivered in one 30-min session per week.
The course of rehabilitation included: sensory integration therapy, cognitive function training and visual perception/auditory attention training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Test of Visual Perceptual Scale-3(TVPS-3)
Time Frame: 4 weeks
|
TVPS-3 is a standardized and norm-referenced task for children age 4-13 years that uses a response format suitable for all children, including those with disabilities.
It includes subtasks of visual discrimination, visual memory, visual-spatial relationships, form constancy, visual sequential memory, figure ground, and visual closure (Martin et al., 2006).
Each of the seven subtests has 16 items of varying difficulty.
Therefore, the test has 112 total questions.
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4 weeks
|
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User satisfaction survey
Time Frame: 4 weeks
|
The 20-item questionnaire content was divided into five themes: perceived ease of use (6 questions), perceived usefulness (4 questions), perceived joyfulness (4 questions), satisfaction (3 questions), and continued use (3 questions).
Questionnaire items were answered on a Likert scale from 1 (completely disagree) to 5 (completely agree).
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4 weeks
|
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Test of the visual-perceptual interactive game system
Time Frame: 4 weeks
|
The digital game test had 7 subtests, and each subtest had 10 questions.
Based on the seven-item rules of TVPS-3, 1 point was assigned to each question, for a score of 10 points for each subtest, and a total score of 70.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
May 24, 2016
Primary Completion (Actual)
May 23, 2017
Study Completion (Actual)
May 23, 2017
Study Registration Dates
First Submitted
August 17, 2021
First Submitted That Met QC Criteria
August 17, 2021
First Posted (Actual)
August 23, 2021
Study Record Updates
Last Update Posted (Actual)
August 23, 2021
Last Update Submitted That Met QC Criteria
August 17, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMUHIRB-SV(II)-20150090
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
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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