Biomechanical Assessment and Biofeedback-training System for Handwriting

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.

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 Overview

• Status: Recruiting
• Conditions: Writing Learning Disability
• Intervention / Treatment: Other: Biofeedback Training; Other: Motor Training

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 701
    • Recruiting
    • National Cheng-Kung University
    • Contact: Li-Chieh Kuo, Ph. D.; Phone Number: 5908 886-62353535; Email: jkkuo@mail.ncku.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 1st part:System development of Adult; 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: 1st part:System development of Child; 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: 2nd part:Handwriting Difficulty; 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.
Experimental: 3rd part: 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 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; Biofeedback training targeted to goals that are relevant to the handwriting skills for children by using a force acquisitional pen.
Experimental: 3rd part: Motor 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; Motor training targeted to goals that are relevant to the handwriting skills for children by using a personal designed motor training program.
No Intervention: 3rd part:Control Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the pinch force	three types of pinch force were recorded by a pinch meter	baseline, 1.5 months

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2016
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: handwriting; kinematics; kinetics; handwriting difficulty
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Learning Disabilities
• Other Study ID Numbers: A-ER-103-385

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No