Clinical trial NCT05605977: Home-based Visual-motor Training Program on Kindergarteners
Official title: Effectiveness of Home-based Visual-motor Training Programs on At-risk Kindergarteners
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Developmental Delay
Preterm Children
Keywords: visual motor, kindergarten children, developmental delay
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pretest-posttest control group design
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the Test of Visual Perceptual Skills-Fourth Edition (TVPS-4)
timeFrame: baseline, after 12 weeks
measure: the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2)
timeFrame: baseline, after 12 weeks
measure: the Chinese Handwriting Test
timeFrame: baseline, after 12 weeks
Secondary outcomes:
measure: The Berry-Buktenica Developmental Test of Visual-Motor Integration- Forth Edition (VMI)
timeFrame: baseline, after 12 weeks
measure: the Vineland Adaptive Behavior Scales - Third Edition - Chinese Version (VABS-3-C) (Parents/Caregivers Edition)adaptive behavior
timeFrame: baseline, after 12 weeks
measure: the test of Visual Perception of Chinese Characters
timeFrame: baseline, after 12 weeks
measure: the Game Questionnaire
timeFrame: through study completion, an average of one week
measure: Parental Feedback Questionnaire
timeFrame: after 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: National Cheng Kung University
name: Yea-Shwu Hwang, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.