Elementary Students With Handwriting DifficultiesNCT05035901
Geometric-Based Handwriting Intervention: Development, Feasibility and Randomized Clinical Trial
A study testing visual-perception motor-coordination integration program in people with Elementary Students With Handwriting Difficulties, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Elementary Students With Handwriting Difficulties
- What is being tested?
- visual-perception motor-coordination integration program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Mar 2021to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. poorer handwriting performance than the peers referred from teachers.
Who cannot join
- severe neurological or pervasive developmental disorders that might directly impeded writing
- intellectual disability that might directly impeded writing
- musculoskeletal, or sensory (hearing, vision) disorders that might directly impeded writing
- difficulty in reading or expressing
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Department of Occupational Therapy
Taipei, 100
Tien Ni Wang, PhD, 886 23366-8163, tnwang@ntu.edu.tw
About this study
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.
- Being tested
- visual-perception motor-coordination integration program
- Keywords
- handwriting, legibility, visual perception, occupational therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual-perception motor-coordination integration programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| visual-perception motor-coordination integration program | Experimental | 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. Receives: Other: visual-perception motor-coordination integration program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline Chinese Legibility Scale (CLS) at one month and 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.
Measured: baseline, one month, six months
The change from baseline Chinese Handwriting Evaluation Form (CHEF) at one month and 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.
Measured: baseline, one month, six months
Secondary outcomes (3)
The change from baseline Developmental Test of Visual Perception - Third Edition (DTVP-3) at one month and 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.
Measured: baseline, one month, six months
The change from baseline Beery-Buktenica Developmental Test of Visual-Motor Integration at one month and 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.
Measured: baseline, one month, six months
Pediatric Motivation Questionnaire (PMQ)
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.
Measured: through study completion, an average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start27 Mar 2021
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elementary Students With Handwriting DifficultiesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035901
- Sponsor's protocol ID
- 202009039RIND
- Status last verified
- Mar 2024
- First submitted
- 23 Aug 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geometric-Based Handwriting Intervention: Development, Feasibility and Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05035901
- Acronym / sponsor ID
- 202009039RIND
- Keywords
- handwriting, legibility, visual perception, occupational therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 27 Mar 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| visual-perception motor-coordination integration program | Experimental | Other: visual-perception motor-coordination integration programVisual-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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. poorer handwriting performance than the peers referred from teachers.
Key exclusion criteria (4 listed)
- severe neurological or pervasive developmental disorders that might directly impeded writing
- intellectual disability that might directly impeded writing
- musculoskeletal, or sensory (hearing, vision) disorders that might directly impeded writing
- difficulty in reading or expressing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| visual-perception motor-coordination integration programVisual-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 |
Primary outcome
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.
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.
3 secondary outcomes
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 change from baseline Beery-Buktenica Developmental Test of Visual-Motor Integration at one month and six months
Time frame: baseline, one month, six months
Pediatric Motivation Questionnaire (PMQ)
Time frame: through study completion, an average of one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visual-perception motor-coordination integration program in people with Elementary Students With Handwriting Difficulties, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tien Ni Wang, PhD (+886 23366-8163, tnwang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline Chinese Legibility Scale (CLS) at one month and six months (time frame: baseline, one month, six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024; AzTrials last refreshed its copy on 27 Oct 2026.