Back to resultsInteractive Digital Game for Improving Visual Perceptual Defects in Children With Developmental Disability
Primary Purpose
Developmental Disability
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Visual-perceptual interactive game system
standard rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Developmental Disability
Eligibility Criteria
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.
Sites / Locations
- Kaohsiung Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Digital game group
Standard rehab group
Arm Description
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.
The standard rehab group received the standard 4-week course of rehabilitation delivered in one 30-min session per week.
Outcomes
Primary Outcome Measures
Test of Visual Perceptual Scale-3(TVPS-3)
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.
User satisfaction survey
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).
Test of the visual-perceptual interactive game system
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05016492
First Posted
August 17, 2021
Last Updated
August 17, 2021
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05016492
Brief Title
Interactive Digital Game for Improving Visual Perceptual Defects in Children With Developmental Disability
Official Title
Interactive Digital Game for Improving Visual Perceptual Defects in Children With Developmental Disability: Evaluation of Efficacy and User Satisfaction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 24, 2016 (Actual)
Primary Completion Date
May 23, 2017 (Actual)
Study Completion Date
May 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Disability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Digital game group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard rehab group
Arm Type
Active Comparator
Arm Description
The standard rehab group received the standard 4-week course of rehabilitation delivered in one 30-min session per week.
Intervention Type
Device
Intervention Name(s)
Visual-perceptual interactive game system
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
standard rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Test of Visual Perceptual Scale-3(TVPS-3)
Description
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.
Time Frame
4 weeks
Title
User satisfaction survey
Description
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).
Time Frame
4 weeks
Title
Test of the visual-perceptual interactive game system
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Kaohsiung Medical University
City
Kaohsiung
ZIP/Postal Code
80708
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
35436215
Citation
Wu WL, Huang YL, Liang JM, Chen CH, Wang CC, Ho WH. Interactive Digital Game for Improving Visual-Perceptual Defects in Children With a Developmental Disability: Randomized Controlled Trial. JMIR Serious Games. 2022 Apr 15;10(2):e34756. doi: 10.2196/34756.
Results Reference
derived
Learn more about this trial
Interactive Digital Game for Improving Visual Perceptual Defects in Children With Developmental Disability
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