Geometric-Based Handwriting Intervention: Development, Feasibility and Randomized Clinical Trial

March 8, 2024 updated by: National Taiwan University Hospital
This study will focus on (1) developing the Chinese characteristic-based VMI-focused program, namely visual-perception motor-coordination integration program (CCVPMCI) involving the most Chinese-handwriting-related skills training and (2) investigating the effectiveness of the CCVPMCI program on handwriting performance in children with handwriting difficulties in Taiwan.

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.

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.
72

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
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Department of Occupational Therapy
        • Contact:

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

7 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

1. poorer handwriting performance than the peers referred from teachers.

Exclusion Criteria:

  1. severe neurological or pervasive developmental disorders that might directly impeded writing
  2. intellectual disability that might directly impeded writing
  3. musculoskeletal, or sensory (hearing, vision) disorders that might directly impeded writing
  4. difficulty in reading or expressing

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Experimental: visual-perception motor-coordination integration program
Visual-perception motor-coordination integration program (CCVPMCI) is a Chinese characteristic-based VMI-focused program involving the most Chinese-handwriting-related skills training. CCVPMCI mainly emphasizes the training role of visual-motor integration. The idea of CCVPMCI program will involve (1) visual motor integration training affiliated with visual perception and motor coordination as warm-up exercise, (2) more focus on visual spatial perception in connect with unique visual structure of Chinese characters, (3) the trace or component elements of Chinese characters as the interesting practice material and (4) appropriate challenge for learning.
Other: visual-perception motor-coordination integration program
Visual-perception motor-coordination integration program (CCVPMCI) is a Chinese characteristic-based VMI-focused program involving the most Chinese-handwriting-related skills training. CCVPMCI mainly emphasizes the training role of visual-motor integration. The idea of CCVPMCI program will involve (1) visual motor integration training affiliated with visual perception and motor coordination as warm-up exercise, (2) more focus on visual spatial perception in connect with unique visual structure of Chinese characters, (3) the trace or component elements of Chinese characters as the interesting practice material and (4) appropriate challenge for learning.

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 change from baseline Chinese Legibility Scale (CLS) at one month and six months
Time Frame: baseline, one month, six months
Chinese Legibility Scale is the self-develop assessment tool to investigate a child's handwriting legibility objectively. Children will be asked to copied 10 Chinese characters on paper within 2*2cm squares to complete the copying paper. Meanwhile, the performance time will be recorded when the child start writing the firs stoke until finish the last stroke of the last character. These Chinese characters are selected from three versions of current mandarin textbooks according to each grade and those with high-frequency and around the average stroke counts will be chosen. Then, characters can be classified into five types of structures based on the visual similarity of character, including top-down (vertical), left-right (horizontal), P-shaped, L-shaped and enclosed. Ultimately, there are 20 characters in total for each grade with five types evenly. The scale will be scored by a therapist blind to the experiment to decide children's writing legibility.
baseline, one month, six months
The change from baseline Chinese Handwriting Evaluation Form (CHEF) at one month and six months
Time Frame: baseline, one month, six months
The CHEF is an observational assessment designed to objectively measure the handwriting performance of school-aged children. It is composed of 25 items and divided into five main dimensions, including construction, accuracy, direction of the characters, writing speed and pencil grip. Items are descriptions of common writing problems by scored on 5-point Likert scale according to the frequency of the problem.
baseline, one month, six months

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
The change from baseline Developmental Test of Visual Perception - Third Edition (DTVP-3) at one month and six months
Time Frame: baseline, one month, six months
The DTVP-3 is commonly used as a standardized and norm-referenced test to assess visual perception skills for children aged 4 through 12 . The testing time will range from approximately 20 to 40 minutes depending on the child's ability. It is composed of 5 subscales: eye-hand coordination (EH), copying (CO), figure-ground (FG), visual closure (VC) and form constancy (FC). The result of the five subtests can be combined to form three composites: motor-enhanced visual perception, motor-reduced visual perception, and general visual perception. The first two subtests involve motor-enhanced visual perception skills and are summed together to represent visual-motor integration abilities. The latter three subtests (FG, VC and FC) are non-motor involved and are summed together to represent motor-reduced visual perception. The combination of motor-enhanced and motor-reduced visual perception could be the general visual perception skills.
baseline, one month, six months
The change from baseline Beery-Buktenica Developmental Test of Visual-Motor Integration at one month and six months
Time Frame: baseline, one month, six months
The Beery-Buktenica Developmental Test of Visual-Motor Integration is a standardized, norm-referenced test to assess visual-motor integration. During the test, the child is required to copy a series of geometric designs, and his/her performance is compared with standard criteria and reference designs.
baseline, one month, six months
Pediatric Motivation Questionnaire (PMQ)
Time Frame: through study completion, an average of one month
The PMQ is an activity-based measurement of motivation and is designed to measure motivation and the experience of receiving specific therapeutic activities . The items of PMQ are modified from existing questionnaires Pediatric Motivation Scale and based on tenets of self-determination theory. The PMQ consists 12 items containing three motivation domain: (1) extrinsic motivation, (2) basic psychological needs, and (3) intrinsic motivation by 5-point Likert scale. The PMQ represents the motivation condition through the intervention from children their own view. In addition, several open-ended questions are added in children's version to reflect perspective of children while receiving the VPMCI program to obtain qualitative information.
through study completion, an average of one month

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 Taiwan University Hospital

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.
March 27, 2021

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.
September 1, 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.
September 1, 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).
August 23, 2021

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.
September 1, 2021

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.
September 5, 2021

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 12, 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 8, 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.
March 1, 2024

More Information

Terms related to this study

Keywords

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.
  • 202009039RIND

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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