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Biomechanical Assessment and Biofeedback-training System for Handwriting

Primary Purpose

Writing Learning Disability

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Biofeedback Training
Motor Training
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Writing Learning Disability focused on measuring handwriting, kinetics, kinematics, handwriting difficulty

Eligibility Criteria

5 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Cheng-Kung UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

No Intervention

No Intervention

No Intervention

Experimental

Experimental

No Intervention

Arm Label

1st part:System development of Adult

1st part:System development of Child

2nd part:Handwriting Difficulty

3rd part: Biofeedback Training

3rd part: Motor Training

3rd part:Control Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in the result of Chinese Handwriting Evaluation Form
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)
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
The kinetic parameters designed by measuring the real finger force applied on a force acquisitional pen.
Change in the handwriting kinematic parameters
The kinematic parameters designed by measuring the real hand motion using motion analysis system.

Secondary Outcome Measures

Change in the pinch force
three types of pinch force were recorded by a pinch meter

Full Information

First Posted
January 28, 2019
Last Updated
June 23, 2023
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03822702
Brief Title
Biomechanical Assessment and Biofeedback-training System for Handwriting
Official Title
An Alternative Perspective to Comprehend Handwriting Performance: Development and Applications of a Biomechanical Assessment and Biofeedback-training System for Handwriting (BABSH)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2016 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Writing Learning Disability
Keywords
handwriting, kinetics, kinematics, handwriting difficulty

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1st part:System development of Adult
Arm Type
No Intervention
Arm Description
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.
Arm Title
1st part:System development of Child
Arm Type
No Intervention
Arm Description
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.
Arm Title
2nd part:Handwriting Difficulty
Arm Type
No Intervention
Arm Description
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.
Arm Title
3rd part: Biofeedback Training
Arm Type
Experimental
Arm Description
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.
Arm Title
3rd part: Motor Training
Arm Type
Experimental
Arm Description
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.
Arm Title
3rd part:Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Biofeedback Training
Intervention Description
Biofeedback training targeted to goals that are relevant to the handwriting skills for children by using a force acquisitional pen.
Intervention Type
Other
Intervention Name(s)
Motor Training
Intervention Description
Motor training targeted to goals that are relevant to the handwriting skills for children by using a personal designed motor training program.
Primary Outcome Measure Information:
Title
Change in the result of Chinese Handwriting Evaluation Form
Description
A questionnaire about handwriting performance. Each item is rated on a five-point ordinal scale
Time Frame
baseline, 1.5 months
Title
Change in the total point score of three subtests of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
Description
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
Title
Change in the handwriting kinetic parameters
Description
The kinetic parameters designed by measuring the real finger force applied on a force acquisitional pen.
Time Frame
baseline, 1.5 months
Title
Change in the handwriting kinematic parameters
Description
The kinematic parameters designed by measuring the real hand motion using motion analysis system.
Time Frame
baseline, 1.5 months
Secondary Outcome Measure Information:
Title
Change in the pinch force
Description
three types of pinch force were recorded by a pinch meter
Time Frame
baseline, 1.5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Able to use pen to write Children volunteers must study in elementary schools Exclusion Criteria: - Handwriting problems are related to muscular, skeletal, nerve and brain damage or disease.
Facility Information:
Facility Name
National Cheng-Kung University
City
Tainan
ZIP/Postal Code
701
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li-Chieh Kuo, Ph. D.
Phone
886-62353535
Ext
5908
Email
jkkuo@mail.ncku.edu.tw

12. IPD Sharing Statement

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Biomechanical Assessment and Biofeedback-training System for Handwriting

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