<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03822702</url>
  </required_header>
  <id_info>
    <org_study_id>A-ER-103-385</org_study_id>
    <nct_id>NCT03822702</nct_id>
  </id_info>
  <brief_title>Biomechanical Assessment and Biofeedback-training System for Handwriting</brief_title>
  <official_title>An Alternative Perspective to Comprehend Handwriting Performance: Development and Applications of a Biomechanical Assessment and Biofeedback-training System for Handwriting (BABSH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng-Kung University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the real-time kinetics of handwriting regarding&#xD;
      the design of the utensil and fine motor performances from biomechanical perspectives. It&#xD;
      includes three parts.&#xD;
&#xD;
      The first part is an observational study design and the specific aim of the first part of the&#xD;
      study is to establish a novel kinetic assessment system incorporated with Force Acquisition&#xD;
      Pens (FAPs) designed with different barrel sizes and shapes for handwriting. The thorough&#xD;
      calibration, examination of reliability and validity will be presented in this study.&#xD;
&#xD;
      The second part is also an observational study design and the specific aim of the second part&#xD;
      of the study is to investigate the handwriting mechanisms using the kinetic assessment system&#xD;
      incorporated with the motion capture system with children who have writing difficulties.&#xD;
&#xD;
      The third part is an interventional study design and the aim of this final part is to&#xD;
      integrate the kinetic assessment system and the intervention concept to establish a&#xD;
      Biomechanical Assessment and Biofeedback-training System for Handwriting (BABSH). Comparison&#xD;
      of the intervention effect of the BABSH and traditional training for the children with&#xD;
      handwriting difficulties will also be carried out in this part.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 9, 2016</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the result of Chinese Handwriting Evaluation Form</measure>
    <time_frame>baseline, 1.5 months</time_frame>
    <description>A questionnaire about handwriting performance. Each item is rated on a five-point ordinal scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the total point score of three subtests of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)</measure>
    <time_frame>baseline, 1.5 months</time_frame>
    <description>These three subtests are 'fine motor precision (subtest-1) ', 'fine motor integration (subtest-2)' and 'manual dexterity (subtest-3)'.&#xD;
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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the handwriting kinetic parameters</measure>
    <time_frame>baseline, 1.5 months</time_frame>
    <description>The kinetic parameters designed by measuring the real finger force applied on a force acquisitional pen.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the handwriting kinematic parameters</measure>
    <time_frame>baseline, 1.5 months</time_frame>
    <description>The kinematic parameters designed by measuring the real hand motion using motion analysis system.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the pinch force</measure>
    <time_frame>baseline, 1.5 months</time_frame>
    <description>three types of pinch force were recorded by a pinch meter</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Writing Learning Disability</condition>
  <arm_group>
    <arm_group_label>1st part:System development of Adult</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention. Subjects need to use 6 types of special pen to do the specific writing tasks for one hour.&#xD;
The same tasks will be ask to do again three days later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1st part:System development of Child</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention. Subjects need to use 6 types of special pen to do the specific writing tasks for one hour.&#xD;
The same tasks will be ask to do again three days later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2nd part:Handwriting Difficulty</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3rd part: Biofeedback Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.&#xD;
For post-test, the same procedure will be ask to do again about one and a half month later .&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3rd part: Motor Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.&#xD;
For post-test, the same procedure will be ask to do again about one and a half month later .&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3rd part:Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.&#xD;
The same procedure will be ask to do again about one and a half month later.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Biofeedback Training</intervention_name>
    <description>Biofeedback training targeted to goals that are relevant to the handwriting skills for children by using a force acquisitional pen.</description>
    <arm_group_label>3rd part: Biofeedback Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Motor Training</intervention_name>
    <description>Motor training targeted to goals that are relevant to the handwriting skills for children by using a personal designed motor training program.</description>
    <arm_group_label>3rd part: Motor Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able to use pen to write&#xD;
&#xD;
          2. Children volunteers must study in elementary schools&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Handwriting problems are related to muscular, skeletal, nerve and brain damage or&#xD;
        disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Cheng-Kung University</name>
      <address>
        <city>Tainan</city>
        <zip>701</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li-Chieh Kuo, Ph. D.</last_name>
      <phone>886-62353535</phone>
      <phone_ext>5908</phone_ext>
      <email>jkkuo@mail.ncku.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>June 23, 2023</last_update_submitted>
  <last_update_submitted_qc>June 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>handwriting</keyword>
  <keyword>kinetics</keyword>
  <keyword>kinematics</keyword>
  <keyword>handwriting difficulty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Learning Disabilities</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03822702
org study id: A-ER-103-385
nct id: NCT03822702
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Change in the result of Chinese Handwriting Evaluation Form
time frame: baseline, 1.5 months
description: A questionnaire about handwriting performance. Each item is rated on a five-point ordinal scale
measure: Change in the total point score of three subtests of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
time frame: baseline, 1.5 months
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).
measure: Change in the handwriting kinetic parameters
time frame: baseline, 1.5 months
description: The kinetic parameters designed by measuring the real finger force applied on a force acquisitional pen.
measure: Change in the handwriting kinematic parameters
time frame: baseline, 1.5 months
description: The kinematic parameters designed by measuring the real hand motion using motion analysis system.
measure: Change in the pinch force
time frame: baseline, 1.5 months
description: three types of pinch force were recorded by a pinch meter
arm group label: 1st part:System development of Adult
arm group type: No Intervention
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 group label: 1st part:System development of Child
arm group type: No Intervention
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 group label: 2nd part:Handwriting Difficulty
arm group type: No Intervention
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 group label: 3rd part: Biofeedback Training
arm group type: Experimental
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 group label: 3rd part: Motor Training
arm group type: Experimental
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 group label: 3rd part:Control Group
arm group type: No Intervention
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: Biofeedback Training
description: Biofeedback training targeted to goals that are relevant to the handwriting skills for children by using a force acquisitional pen.
arm group label: 3rd part: Biofeedback Training
intervention type: Other
intervention name: Motor Training
description: Motor training targeted to goals that are relevant to the handwriting skills for children by using a personal designed motor training program.
arm group label: 3rd part: Motor Training
criteria: 
gender: All
minimum age: 5 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Learning Disabilities