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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05605977
Other study ID # A-ER-110-065
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date October 31, 2024

Study information

Verified date August 2022
Source National Cheng-Kung University Hospital
Contact Yea-Shwu H Hwang, ScD
Phone 886-62353535
Email yshwang@mail.ncku.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date October 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 6 Years
Eligibility Inclusion Criteria: 1. Either visual perception or fine motor score below the norm average 2. can follow instruction and complete the entire tests Exclusion Criteria: 1. Visual or hearing problems that cannot be corrected to be normal 2. A diagnosis of significant neurological, muscular, and skeletal system disorders (e.g., Cerebral palsy) 3. A diagnosis of moderate or severe intellectual disabilities 4. Taking medication to control seizure or improve learning abilities

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Traditional visual-motor training program
Traditional visual-motor program includes play and paper-and-pencil activities
Computerized visual-motor training program
Computerized visual-motor training program includes tablet visual-motor games

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Cheng-Kung University Hospital

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary the Test of Visual Perceptual Skills-Fourth Edition (TVPS-4) the change of visual-perceptual skills baseline, after 12 weeks
Primary the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) the change of fine motor skills baseline, after 12 weeks
Primary the Chinese Handwriting Test the change of the Chinese handwriting performance baseline, after 12 weeks
Secondary The Berry-Buktenica Developmental Test of Visual-Motor Integration- Forth Edition (VMI) the change of VMI baseline, after 12 weeks
Secondary the Vineland Adaptive Behavior Scales - Third Edition - Chinese Version (VABS-3-C) (Parents/Caregivers Edition)adaptive behavior the change of adaptive behavior baseline, after 12 weeks
Secondary the test of Visual Perception of Chinese Characters The change of visual perception of Chinese characters baseline, after 12 weeks
Secondary 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. through study completion, an average of one week
Secondary 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. after 12 weeks
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