An interventional study of Biofeedback Training and Motor Training in Writing Learning Disability, sponsored by National Cheng-Kung University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 5 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-26.
Sponsored by National Cheng-Kung University Hospital · Not applicable, Interventional, and Other
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.
270 studies on the registry are indexed under Learning Disabilities; 62 are open to participants now.
This study's planned enrollment of 125 is above the median of 60 across 181 interventional studies indexed under Learning Disabilities.
Browse Learning Disabilities studies →National Cheng-Kung University Hospital is the lead sponsor of 277 studies on the registry; 70 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
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.
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.
Other: Biofeedback Training
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.
Other: Motor Training
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.
Biofeedback training targeted to goals that are relevant to the handwriting skills for children by using a force acquisitional pen.
Motor training targeted to goals that are relevant to the handwriting skills for children by using a personal designed motor training program.
Change in the result of Chinese Handwriting Evaluation Form
A questionnaire about handwriting performance. Each item is rated on a five-point ordinal scale
Time frame: 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).
Time frame: 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.
Time frame: baseline, 1.5 months
Change in the handwriting kinematic parameters
The kinematic parameters designed by measuring the real hand motion using motion analysis system.
Time frame: baseline, 1.5 months
Change in the pinch force
three types of pinch force were recorded by a pinch meter
Time frame: baseline, 1.5 months
Started May 2016 (actual). Primary completion is estimated for Jun 2025, 109 months after the start.
Of 96 non-industry interventional studies with no phase under Learning Disabilities, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 53. This study's planned 109 months is above that.
Counting every sponsor, half of 99 studies reached it within 29 months; a quarter within 9 and three quarters within 51.
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