Home-based Visual-motor Training Program on Kindergarteners

October 31, 2022 updated by: National Cheng-Kung University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
regular early intervention
EXPERIMENTAL: Traditional visual-motor training program
traditional visual-motor training program plus regular early intervention
Behavioral: Traditional visual-motor training program
Traditional visual-motor program includes play and paper-and-pencil activities
EXPERIMENTAL: Computerized visual-motor training program
computerized visual-motor training program plus regular early intervention
Behavioral: Computerized visual-motor training program
Computerized visual-motor training program includes tablet visual-motor games

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Test of Visual Perceptual Skills-Fourth Edition (TVPS-4)
Time Frame: baseline, after 12 weeks
the change of visual-perceptual skills
baseline, after 12 weeks
the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2)
Time Frame: baseline, after 12 weeks
the change of fine motor skills
baseline, after 12 weeks
the Chinese Handwriting Test
Time Frame: baseline, after 12 weeks
the change of the Chinese handwriting performance
baseline, after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Berry-Buktenica Developmental Test of Visual-Motor Integration- Forth Edition (VMI)
Time Frame: baseline, after 12 weeks
the change of VMI
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 change of adaptive behavior
baseline, after 12 weeks
the test of Visual Perception of Chinese Characters
Time Frame: baseline, after 12 weeks
The change of visual perception of Chinese characters
baseline, after 12 weeks
the Game Questionnaire
Time Frame: through study completion, an average of one week
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
Parental Feedback Questionnaire
Time Frame: after 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2022

Primary Completion (ANTICIPATED)

October 31, 2024

Study Completion (ANTICIPATED)

October 31, 2024

Study Registration Dates

First Submitted

October 23, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (ACTUAL)

November 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A-ER-110-065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD are to be shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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