Visual Perceptual Motor Training on Kindergarteners

March 24, 2024 updated by: National Cheng-Kung University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 701
        • Recruiting
        • National Cheng Kung University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
regular kindergarten education
Experimental: Chinese characters-based visual-motor program
visual perceptual motor activities using Chinese characters as activity materials.
Behavioral: Chinese character-based visuomotor training program
this program includes visual-perceptual-motor play, paper-pencil activities, and ipad games using Chinese character as activity materials
Experimental: traditional visual-motor training program
visual perceptual motor activities using commercial or self-designed toys and pencil-paper sheets as activity materials.
Behavioral: traditional visuomotor training program
this program includes play and paper-and-pencil activities, ipad games using commercial or self-designed stuffs as activity materials

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline, after 12-week intervention, through study completion, an average of 1 year
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
baseline, after 12-week intervention, through study completion, an average of 1 year
The Chinese Handwriting Evaluation Form (preschool version)
Time Frame: baseline, after 12-week intervention
the change of handwriting performance by kindergarten teacher's rating
baseline, after 12-week intervention
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
through study completion, an average of 1 year
The Battery of Chinese Basic Literacy
Time Frame: through study completion, an average of 1 year
the change of reading and handwriting skills
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 change of visual perceptual skills
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 change of fine motor skills
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
the change of VMI
baseline, after 12-week intervention, through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cheng-Kung University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Science and Technology Council

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yea-Shwu Hwang, ScD, National Cheng Kung University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A-ER-111-161

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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