NCT05016492

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2017

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2021

Completed
Last Updated

August 23, 2021

Status Verified

August 1, 2021

Enrollment Period

12 months

First QC Date

August 17, 2021

Last Update Submit

August 17, 2021

Conditions

Developmental Disability

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Digital game group

EXPERIMENTAL

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.

Device: Visual-perceptual interactive game systemBehavioral: standard rehabilitation

Standard rehab group

ACTIVE COMPARATOR

The standard rehab group received the standard 4-week course of rehabilitation delivered in one 30-min session per week.

Behavioral: standard rehabilitation

Interventions

Visual-perceptual interactive game systemDEVICE

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.

Digital game group
standard rehabilitationBEHAVIORAL

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.

Digital game groupStandard rehab group

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Did not follow or understand the instructions for participating in the study
  • Had severe defects in vision, hearing, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, 80708, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 35436215DERIVED

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2021

First Posted

August 23, 2021

Study Start

May 24, 2016

Primary Completion

May 23, 2017

Study Completion

May 23, 2017

Last Updated

August 23, 2021

Record last verified: 2021-08

Locations

TW(1)