Writing Learning Disability Clinical Trial
Official title:
An Alternative Perspective to Comprehend Handwriting Performance: Development and Applications of a Biomechanical Assessment and Biofeedback-training System for Handwriting (BABSH)
| NCT number | NCT03822702 |
| Other study ID # | A-ER-103-385 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 9, 2016 |
| Est. completion date | June 2025 |
| Verified date | June 2023 |
| Source | National Cheng-Kung University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 125 |
| Est. completion date | June 2025 |
| Est. primary completion date | June 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 5 Years to 65 Years |
| Eligibility | Inclusion Criteria: 1. Able to use pen to write 2. Children volunteers must study in elementary schools Exclusion Criteria: - Handwriting problems are related to muscular, skeletal, nerve and brain damage or disease. |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | National Cheng-Kung University | Tainan |
| Lead Sponsor | Collaborator |
|---|---|
| National Cheng-Kung University Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in the result of Chinese Handwriting Evaluation Form | A questionnaire about handwriting performance. Each item is rated on a five-point ordinal scale | baseline, 1.5 months | |
| Primary | 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). |
baseline, 1.5 months | |
| Primary | Change in the handwriting kinetic parameters | The kinetic parameters designed by measuring the real finger force applied on a force acquisitional pen. | baseline, 1.5 months | |
| Primary | Change in the handwriting kinematic parameters | The kinematic parameters designed by measuring the real hand motion using motion analysis system. | baseline, 1.5 months | |
| Secondary | Change in the pinch force | three types of pinch force were recorded by a pinch meter | baseline, 1.5 months |