NCT05605977

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

October 23, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

November 4, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

October 23, 2022

Last Update Submit

October 31, 2022

Conditions

Keywords

visual motor, kindergarten children, developmental delay

Outcome Measures

Primary Outcomes (3)

  • the Test of Visual Perceptual Skills-Fourth Edition (TVPS-4)

    the change of visual-perceptual skills

    baseline, after 12 weeks

  • the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2)

    the change of fine motor skills

    baseline, after 12 weeks

  • the Chinese Handwriting Test

    the change of the Chinese handwriting performance

    baseline, after 12 weeks

Secondary Outcomes (5)

  • The Berry-Buktenica Developmental Test of Visual-Motor Integration- Forth Edition (VMI)

    baseline, after 12 weeks

  • the Vineland Adaptive Behavior Scales - Third Edition - Chinese Version (VABS-3-C) (Parents/Caregivers Edition)adaptive behavior

    baseline, after 12 weeks

  • the test of Visual Perception of Chinese Characters

    baseline, after 12 weeks

  • the Game Questionnaire

    through study completion, an average of one week

  • Parental Feedback Questionnaire

    after 12 weeks

Study Arms (3)

Control group

NO INTERVENTION

regular early intervention

Traditional visual-motor training program

EXPERIMENTAL

traditional visual-motor training program plus regular early intervention

Behavioral: Traditional visual-motor training program

Computerized visual-motor training program

EXPERIMENTAL

computerized visual-motor training program plus regular early intervention

Behavioral: Computerized visual-motor training program

Interventions

Traditional visual-motor program includes play and paper-and-pencil activities

Traditional visual-motor training program

Computerized visual-motor training program includes tablet visual-motor games

Computerized visual-motor training program

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Either visual perception or fine motor score below the norm average
  • can follow instruction and complete the entire tests

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 24120756BACKGROUND
  • Lin 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.

    PMID: 28071977BACKGROUND
  • 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.

    PMID: 20621444BACKGROUND

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Yea-Shwu Hwang, ScD

    National Cheng Kung University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yea-Shwu H Hwang, ScD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessors are blinded to the assigned group of participants
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: pretest-posttest control group design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2022

First Posted

November 4, 2022

Study Start

November 1, 2022

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

November 4, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

IPD are to be shared with other researchers