Developmental DisabilityNCT05016492
Interactive Digital Game for Improving Visual Perceptual Defects in Children With Developmental Disability
A study testing Visual-perceptual interactive game system and standard rehabilitation in people with Developmental Disability, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Developmental Disability
- What is being tested?
- Visual-perceptual interactive game system and standard rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 May 2016to 23 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Did not follow or understand the instructions for participating in the study
- Had severe defects in vision, hearing, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Developmental Disability
- Being tested
- Visual-perceptual interactive game system, standard rehabilitation
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
standard rehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Visual-perceptual interactive game system; Behavioral: 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. Receives: Behavioral: standard rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start24 May 2016
- Primary completion23 May 2017
- Study completion23 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016492
- Sponsor's protocol ID
- KMUHIRB-SV(II)-20150090
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 35436215
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Digital Game for Improving Visual Perceptual Defects in Children With Developmental Disability: Evaluation of Efficacy and User Satisfaction
- ClinicalTrials.gov ID
- NCT05016492
- Acronym / sponsor ID
- KMUHIRB-SV(II)-20150090
- Conditions
- Developmental Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 24 May 2016 (actual)
- Primary completion
- 23 May 2017 (actual)
- Study completion
- 23 May 2017 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital game group | Experimental | Device: Visual-perceptual interactive game system, Behavioral: standard rehabilitationThe digital game group received the standard 4-week course of rehabilitation but with an additional 30-min interactive digital game training session per week. |
| Standard rehab group | Active comparator | Behavioral: standard rehabilitationThe standard rehab group received the standard 4-week course of rehabilitation delivered in one 30-min session per week. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Did not follow or understand the instructions for participating in the study
- Had severe defects in vision, hearing, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual-perceptual interactive game systemSubjects 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. | Device | Digital game group |
| standard rehabilitationSubjects 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. | Behavioural | Digital game group, Standard rehab group |
Primary outcome
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.
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Derived from this study: PubMed 35436215Wu 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.
Related trials for Developmental Disability
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Empower EI: Comparing Early Intervention Approaches to Improve Communication in Toddlers With Developmental Delays
Developmental Delays
Enrolling by invitation
BEhavioral Health Stratified Treatment (BEST) Study for Youth With Intellectual and/or Developmental Disabilities (IDD)
Depression, Anxiety
Active, not recruiting
Community Mobility Plans: Improving Community Participation Through Travel Interventions for Adolescents and Young Adults With Intellectual and Developmental Disabilities
Intellectual and Developmental Disability
Not yet recruitingObservational study
Wearable Sensor Toolkit for Infant Motor Development
Motor Delay, Infant Development
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual-perceptual interactive game system and standard rehabilitation in people with Developmental Disability, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of Visual Perceptual Scale-3(TVPS-3) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05016492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021; AzTrials last refreshed its copy on 30 Oct 2026.