Writing Learning DisabilityNCT03822702
Biomechanical Assessment and Biofeedback-training System for Handwriting
A study testing Biofeedback Training and Motor Training in people with Writing Learning Disability, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to investigate the real-time kinetics of handwriting regarding the design of the utensil and fine motor performances from biomechanical perspectives. It includes three parts. Read more about this study
- Who is it for?
- Ages 5 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Writing Learning Disability
- What is being tested?
- Biofeedback Training and Motor Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 May 2016to Jun 2025
- 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 5 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Able to use pen to write
- Children volunteers must study in elementary schools
Who cannot join
- Handwriting problems are related to muscular, skeletal, nerve and brain damage or disease.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University
Tainan, 701
Li-Chieh Kuo, Ph. D., 886-62353535 ext. 5908, jkkuo@mail.ncku.edu.tw
About this study
Official title: An Alternative Perspective to Comprehend Handwriting Performance: Development and Applications of a Biomechanical Assessment and Biofeedback-training System for Handwriting (BABSH)
The purpose of this study is to investigate the real-time kinetics of handwriting regarding the design of the utensil and fine motor performances from biomechanical perspectives. It includes three parts.
The first part is an observational study design and the specific aim of the first part of the study is to establish a novel kinetic assessment system incorporated with Force Acquisition Pens (FAPs) designed with different barrel sizes and shapes for handwriting. The thorough calibration, examination of reliability and validity will be presented in this study.
Read more
The second part is also an observational study design and the specific aim of the second part of the study is to investigate the handwriting mechanisms using the kinetic assessment system incorporated with the motion capture system with children who have writing difficulties.
The third part is an interventional study design and the aim of this final part is to integrate the kinetic assessment system and the intervention concept to establish a Biomechanical Assessment and Biofeedback-training System for Handwriting (BABSH). Comparison of the intervention effect of the BABSH and traditional training for the children with handwriting difficulties will also be carried out in this part.
- Conditions
- Writing Learning Disability
- Being tested
- Biofeedback Training, Motor Training
- Keywords
- handwriting, kinetics, kinematics, handwriting difficulty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback TrainingOther
Biofeedback training targeted to goals that are relevant to the handwriting skills for children by using a force acquisitional pen.
Motor TrainingOther
Motor training targeted to goals that are relevant to the handwriting skills for children by using a personal designed motor training program.
| Study group | Role | What they receive |
|---|---|---|
| 1st part:System development of Adult | No intervention | No intervention. Subjects need to use 6 types of special pen to do the specific writing tasks for one hour. The same tasks will be ask to do again three days later. |
| 1st part:System development of Child | No intervention | No intervention. Subjects need to use 6 types of special pen to do the specific writing tasks for one hour. The same tasks will be ask to do again three days later. |
| 2nd part:Handwriting Difficulty | No intervention | No intervention. Subjects need to do the specific writing tasks and fine motor test for one hour with sensors on the hand. A handwriting screening questionnaire shall be filled. |
| 3rd part: Biofeedback Training | Experimental | This program includes 1 hour pre-test, 8 times training and 1 hour post-test. For pre-test, subjects need to do the specific writing tasks and fine motor test for one hour. A handwriting screening questionnaire shall be filled.
For post-test, the same procedure will be ask to do again about one and a half month later .
After pre-test, eight times of Biofeedback Training will be asked. Each time will take 50 minutes, one or two times a week. All training will be completed in about one and a half month. Receives: Other: Biofeedback Training |
| 3rd part: Motor Training | Experimental | This program includes 1 hour pre-test, 8 times training and 1 hour post-test. For pre-test, subjects need to do the specific writing tasks and fine motor test for one hour. A handwriting screening questionnaire shall be filled.
For post-test, the same procedure will be ask to do again about one and a half month later .
After pre-test, eight times of Motor Training will be asked. Each time will take 50 minutes, one or two times a week. All training will be completed in about one and a half month. Receives: Other: Motor Training |
| 3rd part:Control Group | No intervention | No intervention. Subjects need to do the specific writing tasks and fine motor test for one hour. A handwriting screening questionnaire shall be filled. The same procedure will be ask to do again about one and a half month later. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the result of Chinese Handwriting Evaluation Form
A questionnaire about handwriting performance. Each item is rated on a five-point ordinal scale
Measured: baseline, 1.5 months
Change in the total point score of three subtests of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
These three subtests are 'fine motor precision (subtest-1) ', 'fine motor integration (subtest-2)' and 'manual dexterity (subtest-3)'.
The raw scores of the three subtests were then transformed into point scores based on the BOT-2 manual. The total point scores of the three subtests will be analyzed. For subtest-1, the range of total point score is 0 to 41. For subtest-2, the range of total point score is 0 to 40. For subtest-3, the range of total point score is 0 to 45. Higher total point scores represent a better performance (outcome).
Measured: baseline, 1.5 months
Change in the handwriting kinetic parameters
The kinetic parameters designed by measuring the real finger force applied on a force acquisitional pen.
Measured: baseline, 1.5 months
Change in the handwriting kinematic parameters
The kinematic parameters designed by measuring the real hand motion using motion analysis system.
Measured: baseline, 1.5 months
Secondary outcomes (1)
Change in the pinch force
three types of pinch force were recorded by a pinch meter
Measured: baseline, 1.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start9 May 2016
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Writing Learning DisabilityStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822702
- Sponsor's protocol ID
- A-ER-103-385
- Status last verified
- Jun 2023
- First submitted
- 28 Jan 2019
- Last updated
- 26 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Alternative Perspective to Comprehend Handwriting Performance: Development and Applications of a Biomechanical Assessment and Biofeedback-training System for Handwriting (BABSH)
- ClinicalTrials.gov ID
- NCT03822702
- Acronym / sponsor ID
- A-ER-103-385
- Conditions
- Writing Learning Disability
- Keywords
- handwriting, kinetics, kinematics, handwriting difficulty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 9 May 2016 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 30 Jan 2019 (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.
The purpose of this study is to investigate the real-time kinetics of handwriting regarding the design of the utensil and fine motor performances from biomechanical perspectives. It includes three parts.
The first part is an observational study design and the specific aim of the first part of the study is to establish a novel kinetic assessment system incorporated with Force Acquisition Pens (FAPs) designed with different barrel sizes and shapes for handwriting. The thorough calibration, examination of reliability and validity will be presented in this study.
The second part is also an observational study design and the specific aim of the second part of the study is to investigate the handwriting mechanisms using the kinetic assessment system incorporated with the motion capture system with children who have writing difficulties.
The third part is an interventional study design and the aim of this final part is to integrate the kinetic assessment system and the intervention concept to establish a Biomechanical Assessment and Biofeedback-training System for Handwriting (BABSH). Comparison of the intervention effect of the BABSH and traditional training for the children with handwriting difficulties will also be carried out in this part.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1st part:System development of Adult | No intervention | –No intervention. Subjects need to use 6 types of special pen to do the specific writing tasks for one hour. The same tasks will be ask to do again three days later. |
| 1st part:System development of Child | No intervention | –No intervention. Subjects need to use 6 types of special pen to do the specific writing tasks for one hour. The same tasks will be ask to do again three days later. |
| 2nd part:Handwriting Difficulty | No intervention | –No intervention. Subjects need to do the specific writing tasks and fine motor test for one hour with sensors on the hand. A handwriting screening questionnaire shall be filled. |
| 3rd part: Biofeedback Training | Experimental | Other: Biofeedback TrainingThis program includes 1 hour pre-test, 8 times training and 1 hour post-test. For pre-test, subjects need to do the specific writing tasks and fine motor test for one hour. A handwriting screening questionnaire shall be filled. For post-test, the same procedure will be ask to do again about one and a half month later . After pre-test, eight times of Biofeedback Training will be asked. Each time will take 50 minutes, one or two times a week. All training will be completed in about one and a half month. |
| 3rd part: Motor Training | Experimental | Other: Motor TrainingThis program includes 1 hour pre-test, 8 times training and 1 hour post-test. For pre-test, subjects need to do the specific writing tasks and fine motor test for one hour. A handwriting screening questionnaire shall be filled. For post-test, the same procedure will be ask to do again about one and a half month later . After pre-test, eight times of Motor Training will be asked. Each time will take 50 minutes, one or two times a week. All training will be completed in about one and a half month. |
| 3rd part:Control Group | No intervention | –No intervention. Subjects need to do the specific writing tasks and fine motor test for one hour. A handwriting screening questionnaire shall be filled. The same procedure will be ask to do again about one and a half month later. |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Able to use pen to write
- Children volunteers must study in elementary schools
Key exclusion criteria (1 listed)
- Handwriting problems are related to muscular, skeletal, nerve and brain damage or disease.
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 |
|---|---|---|
| Biofeedback TrainingBiofeedback training targeted to goals that are relevant to the handwriting skills for children by using a force acquisitional pen. | Other | 3rd part: Biofeedback Training |
| Motor TrainingMotor training targeted to goals that are relevant to the handwriting skills for children by using a personal designed motor training program. | Other | 3rd part: Motor Training |
Primary outcome
Change in the result of Chinese Handwriting Evaluation Form
Time frame: baseline, 1.5 months
A questionnaire about handwriting performance. Each item is rated on a five-point ordinal scale
Change in the total point score of three subtests of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
Time frame: baseline, 1.5 months
These three subtests are 'fine motor precision (subtest-1) ', 'fine motor integration (subtest-2)' and 'manual dexterity (subtest-3)'. The raw scores of the three subtests were then transformed into point scores based on the BOT-2 manual. The total point scores of the three subtests will be analyzed. For subtest-1, the range of total point score is 0 to 41. For subtest-2, the range of total point score is 0 to 40. For subtest-3, the range of total point score is 0 to 45. Higher total point scores represent a better performance (outcome).
Change in the handwriting kinetic parameters
Time frame: baseline, 1.5 months
The kinetic parameters designed by measuring the real finger force applied on a force acquisitional pen.
Change in the handwriting kinematic parameters
Time frame: baseline, 1.5 months
The kinematic parameters designed by measuring the real hand motion using motion analysis system.
1 secondary outcome
Change in the pinch force
Time frame: baseline, 1.5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
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 Biofeedback Training and Motor Training in people with Writing Learning Disability, run by National Cheng-Kung 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 2 inclusion and 1 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 26 Jun 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the result of Chinese Handwriting Evaluation Form (time frame: baseline, 1.5 months). The study lists 4 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 26 Jun 2023; AzTrials last refreshed its copy on 1 Nov 2026.