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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05016492
Other study ID # KMUHIRB-SV(II)-20150090
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 24, 2016
Est. completion date May 23, 2017

Study information

Verified date August 2021
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date May 23, 2017
Est. primary completion date May 23, 2017
Accepts healthy volunteers No
Gender All
Age group 4 Years to 10 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Visual-perceptual interactive game system
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.
Behavioral:
standard rehabilitation
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.

Locations

Country Name City State
Taiwan Kaohsiung Medical University Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks
Primary 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). 4 weeks
Primary 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. 4 weeks
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