Biomechanical Assessment and Biofeedback-training System for Handwriting

National Cheng-Kung University

Status: Enrolling

Conditions: Writing Learning Disability

Treatments: Other: Motor Training; Other: Biofeedback Training

Study type: Interventional

Funder types: Other

Identifiers

NCT03822702

A-ER-103-385

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 5 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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125 participants in 6 patient groups

1st part:System development of Adult

No Intervention group

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.

1st part:System development of Child

No Intervention group

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.

2nd part:Handwriting Difficulty

No Intervention group

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.

3rd part: Biofeedback Training

Experimental group

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.

Treatment:

Other: Biofeedback Training

3rd part: Motor Training

Experimental group

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.

Treatment:

Other: Motor Training

3rd part:Control Group

No Intervention group

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.