Developmental DelayNCT05605977
Home-based Visual-motor Training Program on Kindergarteners
A study testing Traditional visual-motor training program and Computerized visual-motor training program in people with Developmental Delay and Preterm Children, run by National Cheng-Kung University Hospital.
Trial summary
The study aims to investigate the feasibility and effectiveness of the traditional and computerized home-based visual-motor training programs on at-risk kindergarteners. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Delay, Preterm Children
- What is being tested?
- Traditional visual-motor training program and Computerized visual-motor training program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 31 Oct 2024
- 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 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Either visual perception or fine motor score below the norm average
- can follow instruction and complete the entire tests
Who cannot join
- Visual or hearing problems that cannot be corrected to be normal
- A diagnosis of significant neurological, muscular, and skeletal system disorders (e.g., Cerebral palsy)
- A diagnosis of moderate or severe intellectual disabilities
- Taking medication to control seizure or improve learning abilities
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Home-based Visual-motor Training Programs on At-risk Kindergarteners
The study aims to investigate the feasibility and effectiveness of the traditional and computerized home-based visual-motor training programs on at-risk kindergarteners.
Read the detailed description
The purpose of this project is to investigate the feasibility and effectiveness of home-based traditional visual-motor activities and tablet games on fine motor, visual perception, visuo-motor integration, handwriting performance, and adaptive behaviors of at-risk kindergarteners. At-risk kindergarteners will be randomized into the three groups: control, traditional, and tablet groups. In addition to regular early intervention, children in the traditional and tablet group will receive home-based visuo-motor training program with their parents. Children in the control group will only receive regular intervention during the study period.
- Conditions
- Developmental Delay, Preterm Children
- Being tested
- Traditional visual-motor training program, Computerized visual-motor training program
- Keywords
- visual motor, kindergarten children, developmental delay
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional visual-motor training programBehavioural
Traditional visual-motor program includes play and paper-and-pencil activities
Computerized visual-motor training programBehavioural
Computerized visual-motor training program includes tablet visual-motor games
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | regular early intervention |
| Traditional visual-motor training program | Experimental | traditional visual-motor training program plus regular early intervention Receives: Behavioral: Traditional visual-motor training program |
| Computerized visual-motor training program | Experimental | computerized visual-motor training program plus regular early intervention Receives: Behavioral: Computerized visual-motor training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Test of Visual Perceptual Skills-Fourth Edition (TVPS-4)
the change of visual-perceptual skills
Measured: baseline, after 12 weeks
the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2)
the change of fine motor skills
Measured: baseline, after 12 weeks
the Chinese Handwriting Test
the change of the Chinese handwriting performance
Measured: baseline, after 12 weeks
Secondary outcomes (5)
The Berry-Buktenica Developmental Test of Visual-Motor Integration- Forth Edition (VMI)
the change of VMI
Measured: baseline, after 12 weeks
the Vineland Adaptive Behavior Scales - Third Edition - Chinese Version (VABS-3-C) (Parents/Caregivers Edition)adaptive behavior
the change of adaptive behavior
Measured: baseline, after 12 weeks
the test of Visual Perception of Chinese Characters
The change of visual perception of Chinese characters
Measured: baseline, after 12 weeks
the Game Questionnaire
The questionnaire is designed to measure the difficulty, participation, and liking level of playing the training games using 5-point Likert scale from parental view after the completion of the games.
Measured: through study completion, an average of one week
Parental Feedback Questionnaire
The questionnaire consists of a few open-ended questions which are designed to realize parental experience of participating the home-based visual-motor training program.
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start1 Nov 2022 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Developmental DelayStudies 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
- Model description
- pretest-posttest control group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yea-Shwu Hwang, ScD, Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605977
- Sponsor's protocol ID
- A-ER-110-065
- Status last verified
- Aug 2022
- First submitted
- 23 Oct 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are to be shared with other researchers
Publications
Chen YN, Lin CK, Wei TS, Liu CH, Wuang YP. The effectiveness of multimedia visual perceptual training groups for the preschool children with developmental delay. Res Dev Disabil. 2013 Dec;34(12):4447-54. doi: 10.1016/j.ridd.2013.09.023. Epub 2013 Oct 11.
PubMed 24120756Lin LY, Cherng RJ, Chen YJ. Effect of Touch Screen Tablet Use on Fine Motor Development of Young Children. Phys Occup Ther Pediatr. 2017 Oct 20;37(5):457-467. doi: 10.1080/01942638.2016.1255290. Epub 2017 Jan 10.
PubMed 28071977Poon KW, Li-Tsang CW, Weiss TP, Rosenblum S. The effect of a computerized visual perception and visual-motor integration training program on improving Chinese handwriting of children with handwriting difficulties. Res Dev Disabil. 2010 Nov-Dec;31(6):1552-60. doi: 10.1016/j.ridd.2010.06.001.
PubMed 20621444
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Home-based Visual-motor Training Programs on At-risk Kindergarteners
- ClinicalTrials.gov ID
- NCT05605977
- Acronym / sponsor ID
- A-ER-110-065
- Conditions
- Developmental Delay, Preterm Children
- Keywords
- visual motor, kindergarten children, developmental delay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 4 Nov 2022 (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.
The study aims to investigate the feasibility and effectiveness of the traditional and computerized home-based visual-motor training programs on at-risk kindergarteners.
Detailed description
The purpose of this project is to investigate the feasibility and effectiveness of home-based traditional visual-motor activities and tablet games on fine motor, visual perception, visuo-motor integration, handwriting performance, and adaptive behaviors of at-risk kindergarteners. At-risk kindergarteners will be randomized into the three groups: control, traditional, and tablet groups. In addition to regular early intervention, children in the traditional and tablet group will receive home-based visuo-motor training program with their parents. Children in the control group will only receive regular intervention during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- pretest-posttest control group design
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –regular early intervention |
| Traditional visual-motor training program | Experimental | Behavioral: Traditional visual-motor training programtraditional visual-motor training program plus regular early intervention |
| Computerized visual-motor training program | Experimental | Behavioral: Computerized visual-motor training programcomputerized visual-motor training program plus regular early intervention |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Either visual perception or fine motor score below the norm average
- can follow instruction and complete the entire tests
Key exclusion criteria (4 listed)
- Visual or hearing problems that cannot be corrected to be normal
- A diagnosis of significant neurological, muscular, and skeletal system disorders (e.g., Cerebral palsy)
- A diagnosis of moderate or severe intellectual disabilities
- Taking medication to control seizure or improve learning abilities
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 |
|---|---|---|
| Traditional visual-motor training programTraditional visual-motor program includes play and paper-and-pencil activities | Behavioural | Traditional visual-motor training program |
| Computerized visual-motor training programComputerized visual-motor training program includes tablet visual-motor games | Behavioural | Computerized visual-motor training program |
Primary outcome
the Test of Visual Perceptual Skills-Fourth Edition (TVPS-4)
Time frame: baseline, after 12 weeks
the change of visual-perceptual skills
the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2)
Time frame: baseline, after 12 weeks
the change of fine motor skills
the Chinese Handwriting Test
Time frame: baseline, after 12 weeks
the change of the Chinese handwriting performance
5 secondary outcomes
The Berry-Buktenica Developmental Test of Visual-Motor Integration- Forth Edition (VMI)
Time frame: baseline, after 12 weeks
the Vineland Adaptive Behavior Scales - Third Edition - Chinese Version (VABS-3-C) (Parents/Caregivers Edition)adaptive behavior
Time frame: baseline, after 12 weeks
the test of Visual Perception of Chinese Characters
Time frame: baseline, after 12 weeks
the Game Questionnaire
Time frame: through study completion, an average of one week
Parental Feedback Questionnaire
Time frame: after 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Background: PubMed 24120756Chen YN, Lin CK, Wei TS, Liu CH, Wuang YP. The effectiveness of multimedia visual perceptual training groups for the preschool children with developmental delay. Res Dev Disabil. 2013 Dec;34(12):4447-54. doi: 10.1016/j.ridd.2013.09.023. Epub 2013 Oct 11.
- Background: PubMed 28071977Lin LY, Cherng RJ, Chen YJ. Effect of Touch Screen Tablet Use on Fine Motor Development of Young Children. Phys Occup Ther Pediatr. 2017 Oct 20;37(5):457-467. doi: 10.1080/01942638.2016.1255290. Epub 2017 Jan 10.
- Background: PubMed 20621444Poon KW, Li-Tsang CW, Weiss TP, Rosenblum S. The effect of a computerized visual perception and visual-motor integration training program on improving Chinese handwriting of children with handwriting difficulties. Res Dev Disabil. 2010 Nov-Dec;31(6):1552-60. doi: 10.1016/j.ridd.2010.06.001.
- Individual participant dataSharing planned: No. IPD are to be shared with other researchers
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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.
Yea-Shwu Hwang, ScD principal investigator
National Cheng Kung University
Questions about this trial
What is this clinical trial studying?
A study testing Traditional visual-motor training program and Computerized visual-motor training program in people with Developmental Delay and Preterm Children, run by National Cheng-Kung University Hospital.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yea-Shwu H Hwang, ScD (886-62353535 ext. 5914, yshwang@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Test of Visual Perceptual Skills-Fourth Edition (TVPS-4) (time frame: baseline, after 12 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 NCT05605977, which also lists 3 linked publications.
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 4 Nov 2022.