AgraphiaNCT05795738

Visual Perceptual Motor Training on Kindergarteners

A study testing Chinese character-based visuomotor training program and traditional visuomotor training program in people with Agraphia, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The study aims to investigate the effects of different visuomotor training programs on children's visuomotor skills and handwriting performance. Read more about this study

Who is it for?: Ages 5 to 6 yearsHealthy volunteers can take part
Conditions the study is for: Agraphia
What is being tested?: Chinese character-based visuomotor training program and traditional visuomotor training program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 1 siteTaiwan
Study dates: 1 Nov 2022to 31 Aug 2026
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

Kindergarten children who will study the first grade in coming September
Both parents are native Mandarin Chinese speakers

Who cannot join

A diagnosis of significant neurological, muscular, and skeletal system disorders
Visual or hearing problems that cannot be corrected to be normal
Genetic or chromosomal abnormality
Significant neurological, muscular, and skeletal damage to the trunk or upper extremities
moderate or severe intellectual disabilities

Trial locations and contacts

1 site in 1 country.

Yea-Shwu H Hwang, ScD contact

886-62353535 ext. 5914

yshwang@mail.ncku.edu.tw

Taiwan1 site, 1 recruiting

National Cheng Kung University
Tainan, 701
Recruiting

Other trials in Taiwan

About this study

Official title: Effects of Different Visual-perceptual-motor Training Courses on Kindergarten Children

The study aims to investigate the effects of different visuomotor training programs on children's visuomotor skills and handwriting performance.

Read the detailed description

The purpose of this project is to investigate the effectiveness of visuomotor activities with different activity materials on fine motor, visual perception, visual-motor integration and handwriting performance of kindergarten children. Kindergarteners will be randomized into the three groups: control, Chinese, and traditional groups. Children in the Chinese and traditional groups will receive a visual perceptual motor training program twice every week for 12 weeks and those in the control group will not receive any intervention during the study period. in the end of fall semester of the first grade, the effectiveness of the interventional programs on handwriting performance of participants will be examined again.

Conditions: Agraphia
Being tested: Chinese character-based visuomotor training program, traditional visuomotor training program
Keywords: Visual, Kindergarten, Chinese
Medical subject headings: Agraphia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chinese character-based visuomotor training programBehavioural
this program includes visual-perceptual-motor play, paper-pencil activities, and ipad games using Chinese character as activity materials
traditional visuomotor training programBehavioural
this program includes play and paper-and-pencil activities, ipad games using commercial or self-designed stuffs as activity materials

Study groups in NCT05795738
Study group	Role	What they receive
Control group	No intervention	regular kindergarten education
Chinese characters-based visual-motor program	Experimental	visual perceptual motor activities using Chinese characters as activity materials. Receives: Behavioral: Chinese character-based visuomotor training program
traditional visual-motor training program	Experimental	visual perceptual motor activities using commercial or self-designed toys and pencil-paper sheets as activity materials. Receives: Behavioral: traditional visuomotor training program

What is being measured

The primary outcome is the main question the study is designed to answer.

The Chinese Handwriting Test
the change of the handwriting performance
Measured: baseline, after 12-week intervention, through study completion, an average of 1 year
The Chinese character recognition Test
the change of the Chinese character recognition ability
Measured: baseline, after 12-week intervention, through study completion, an average of 1 year
The Chinese Handwriting Evaluation Form (preschool version)
the change of handwriting performance by kindergarten teacher's rating
Measured: baseline, after 12-week intervention
The Chinese Handwriting Evaluation Form (School-aged version)
the change of handwriting skills by teacher's rating
Measured: through study completion, an average of 1 year
The Battery of Chinese Basic Literacy
the change of reading and handwriting skills
Measured: through study completion, an average of 1 year

Secondary outcomes (3)

Test of Visual Perceptual Skills-Fourth Edition (TVPS-4)
the change of visual perceptual skills
Measured: baseline, after 12-week intervention, through study completion, an average of 1 year
The Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2)
the change of fine motor skills
Measured: baseline, after 12-week intervention, through study completion, an average of 1 year
The Berry-Buktenica Developmental Test of Visual-Motor Integration- Forth Edition (VMI)
the change of VMI
Measured: baseline, after 12-week intervention, through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202231 Aug 2026

First posted3 Apr 2023
Study start1 Nov 2022
Primary completion31 Aug 2026 (estimated)
Study completion31 Aug 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for AgraphiaStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 180 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05795738
Sponsor's protocol ID: A-ER-111-161
Status last verified: May 2023
First submitted: 5 Mar 2023
Last updated: 26 Mar 2024
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 24120756
Chang SH, Yu NY. Visual and Haptic Perception Training to Improve Handwriting Skills in Children With Dysgraphia. Am J Occup Ther. 2017 Mar/Apr;71(2):7102220030p1-7102220030p10. doi: 10.5014/ajot.2017.021311.
PubMed 28218589
Dankert HL, Davies PL, Gavin WJ. Occupational therapy effects on visual-motor skills in preschool children. Am J Occup Ther. 2003 Sep-Oct;57(5):542-9. doi: 10.5014/ajot.57.5.542.
PubMed 14527116
Daly CJ, Kelley GT, Krauss A. Relationship between visual-motor integration and handwriting skills of children in kindergarten: a modified replication study. Am J Occup Ther. 2003 Jul-Aug;57(4):459-62. doi: 10.5014/ajot.57.4.459.
PubMed 12911088
Feder KP, Majnemer A, Bourbonnais D, Platt R, Blayney M, Synnes A. Handwriting performance in preterm children compared with term peers at age 6 to 7 years. Dev Med Child Neurol. 2005 Mar;47(3):163-70. doi: 10.1017/s0012162205000307.
PubMed 15739720
Feder KP, Majnemer A. Handwriting development, competency, and intervention. Dev Med Child Neurol. 2007 Apr;49(4):312-7. doi: 10.1111/j.1469-8749.2007.00312.x.
PubMed 17376144
Hwang YS, Su PF, Hsiao YL, Tsai WH, Hung JY. Developing a Nomogram Model to Predict the Risk of Poor Chinese Handwriting in First Grade. Am J Occup Ther. 2020 Sep/Oct;74(5):7405205080p1-7405205080p8. doi: 10.5014/ajot.2020.038711.
PubMed 32804626
Lee TI, Howe TH, Chen HL, Wang TN. Predicting Handwriting Legibility in Taiwanese Elementary School Children. Am J Occup Ther. 2016 Nov/Dec;70(6):7006220020p1-7006220020p9. doi: 10.5014/ajot.2016.016865.
PubMed 27767941
Ohl AM, Graze H, Weber K, Kenny S, Salvatore C, Wagreich S. Effectiveness of a 10-week tier-1 response to intervention program in improving fine motor and visual-motor skills in general education kindergarten students. Am J Occup Ther. 2013 Sep-Oct;67(5):507-14. doi: 10.5014/ajot.2013.008110.
PubMed 23968788
Poon 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
Prunty M, Barnett AL, Wilmut K, Plumb M. Visual perceptual and handwriting skills in children with Developmental Coordination Disorder. Hum Mov Sci. 2016 Oct;49:54-65. doi: 10.1016/j.humov.2016.06.003. Epub 2016 Jun 18.
PubMed 27327259
Ratzon NZ, Efraim D, Bart O. A short-term graphomotor program for improving writing readiness skills of first-grade students. Am J Occup Ther. 2007 Jul-Aug;61(4):399-405. doi: 10.5014/ajot.61.4.399.
PubMed 17685172
Taverna L, Tremolada M, Dozza L, Zanin Scaratti R, Ulrike D, Lallo C, Tosetto B. Who Benefits from An Intervention Program on Foundational Skills for Handwriting Addressed to Kindergarten Children and First Graders? Int J Environ Res Public Health. 2020 Mar 24;17(6):2166. doi: 10.3390/ijerph17062166.
PubMed 32214003
Tse LF, Thanapalan KC, Chan CC. Visual-perceptual-kinesthetic inputs on influencing writing performances in children with handwriting difficulties. Res Dev Disabil. 2014 Feb;35(2):340-7. doi: 10.1016/j.ridd.2013.11.013. Epub 2013 Dec 11.
PubMed 24333804
Tseng MH, Chow SM. Perceptual-motor function of school-age children with slow handwriting speed. Am J Occup Ther. 2000 Jan-Feb;54(1):83-8. doi: 10.5014/ajot.54.1.83.
PubMed 10686631

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Different Visual-perceptual-motor Training Courses on Kindergarten Children
ClinicalTrials.gov ID: NCT05795738
Acronym / sponsor ID: A-ER-111-161
Conditions: Agraphia
Keywords: Visual, Kindergarten, Chinese
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 180 participants (estimated)
Lead sponsor: National Cheng-Kung University HospitalUniversity, hospital or other
Collaborators: National Science and Technology Council
Study start: 1 Nov 2022 (actual)
Primary completion: 31 Aug 2026 (estimated)
Study completion: 31 Aug 2026 (estimated)
First posted: 3 Apr 2023 (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 effects of different visuomotor training programs on children's visuomotor skills and handwriting performance.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Control group	No intervention	–regular kindergarten education
Chinese characters-based visual-motor program	Experimental	Behavioral: Chinese character-based visuomotor training programvisual perceptual motor activities using Chinese characters as activity materials.
traditional visual-motor training program	Experimental	Behavioral: traditional visuomotor training programvisual perceptual motor activities using commercial or self-designed toys and pencil-paper sheets as activity materials.

Who may qualify

Ages: 5 to 6 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Kindergarten children who will study the first grade in coming September
Both parents are native Mandarin Chinese speakers

Key exclusion criteria (5 listed)

A diagnosis of significant neurological, muscular, and skeletal system disorders
Visual or hearing problems that cannot be corrected to be normal
Genetic or chromosomal abnormality
Significant neurological, muscular, and skeletal damage to the trunk or upper extremities
moderate or severe intellectual disabilities

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
Chinese character-based visuomotor training programthis program includes visual-perceptual-motor play, paper-pencil activities, and ipad games using Chinese character as activity materials	Behavioural	Chinese characters-based visual-motor program
traditional visuomotor training programthis program includes play and paper-and-pencil activities, ipad games using commercial or self-designed stuffs as activity materials	Behavioural	traditional visual-motor training program

Primary outcome

The Chinese Handwriting Test
Time frame: baseline, after 12-week intervention, through study completion, an average of 1 year
the change of the handwriting performance
The Chinese character recognition Test
Time frame: baseline, after 12-week intervention, through study completion, an average of 1 year
the change of the Chinese character recognition ability
The Chinese Handwriting Evaluation Form (preschool version)
Time frame: baseline, after 12-week intervention
the change of handwriting performance by kindergarten teacher's rating
The Chinese Handwriting Evaluation Form (School-aged version)
Time frame: through study completion, an average of 1 year
the change of handwriting skills by teacher's rating
The Battery of Chinese Basic Literacy
Time frame: through study completion, an average of 1 year
the change of reading and handwriting skills

3 secondary outcomes

Test of Visual Perceptual Skills-Fourth Edition (TVPS-4)
Time frame: baseline, after 12-week intervention, through study completion, an average of 1 year
The Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2)
Time frame: baseline, after 12-week intervention, through study completion, an average of 1 year
The Berry-Buktenica Developmental Test of Visual-Motor Integration- Forth Edition (VMI)
Time frame: baseline, after 12-week intervention, through study completion, an average of 1 year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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 28218589Chang SH, Yu NY. Visual and Haptic Perception Training to Improve Handwriting Skills in Children With Dysgraphia. Am J Occup Ther. 2017 Mar/Apr;71(2):7102220030p1-7102220030p10. doi: 10.5014/ajot.2017.021311.
Background: PubMed 14527116Dankert HL, Davies PL, Gavin WJ. Occupational therapy effects on visual-motor skills in preschool children. Am J Occup Ther. 2003 Sep-Oct;57(5):542-9. doi: 10.5014/ajot.57.5.542.
Background: PubMed 12911088Daly CJ, Kelley GT, Krauss A. Relationship between visual-motor integration and handwriting skills of children in kindergarten: a modified replication study. Am J Occup Ther. 2003 Jul-Aug;57(4):459-62. doi: 10.5014/ajot.57.4.459.
Background: PubMed 15739720Feder KP, Majnemer A, Bourbonnais D, Platt R, Blayney M, Synnes A. Handwriting performance in preterm children compared with term peers at age 6 to 7 years. Dev Med Child Neurol. 2005 Mar;47(3):163-70. doi: 10.1017/s0012162205000307.
Background: PubMed 17376144Feder KP, Majnemer A. Handwriting development, competency, and intervention. Dev Med Child Neurol. 2007 Apr;49(4):312-7. doi: 10.1111/j.1469-8749.2007.00312.x.
Background: PubMed 32804626Hwang YS, Su PF, Hsiao YL, Tsai WH, Hung JY. Developing a Nomogram Model to Predict the Risk of Poor Chinese Handwriting in First Grade. Am J Occup Ther. 2020 Sep/Oct;74(5):7405205080p1-7405205080p8. doi: 10.5014/ajot.2020.038711.
Background: PubMed 27767941Lee TI, Howe TH, Chen HL, Wang TN. Predicting Handwriting Legibility in Taiwanese Elementary School Children. Am J Occup Ther. 2016 Nov/Dec;70(6):7006220020p1-7006220020p9. doi: 10.5014/ajot.2016.016865.
Background: PubMed 23968788Ohl AM, Graze H, Weber K, Kenny S, Salvatore C, Wagreich S. Effectiveness of a 10-week tier-1 response to intervention program in improving fine motor and visual-motor skills in general education kindergarten students. Am J Occup Ther. 2013 Sep-Oct;67(5):507-14. doi: 10.5014/ajot.2013.008110.
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.
Background: PubMed 27327259Prunty M, Barnett AL, Wilmut K, Plumb M. Visual perceptual and handwriting skills in children with Developmental Coordination Disorder. Hum Mov Sci. 2016 Oct;49:54-65. doi: 10.1016/j.humov.2016.06.003. Epub 2016 Jun 18.
Background: PubMed 17685172Ratzon NZ, Efraim D, Bart O. A short-term graphomotor program for improving writing readiness skills of first-grade students. Am J Occup Ther. 2007 Jul-Aug;61(4):399-405. doi: 10.5014/ajot.61.4.399.
Individual participant dataSharing planned: No. IPD are to be shared with other researchers

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 H Hwang, ScD contact

886-62353535 ext. 5914

yshwang@mail.ncku.edu.tw

Yea-Shwu Hwang, ScD principal investigator

National Cheng Kung University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 26 Mar 2024. 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?

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 Chinese Handwriting Test (time frame: baseline, after 12-week intervention, through study completion, an average of 1 year). The study lists 5 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 NCT05795738, which also lists 17 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 26 Mar 2024.