A Preliminary Study on Digital Learning Aids for Special Children With TRIZ and 3D Printing Technology

December 10, 2024 updated by: Taipei Medical University Shuang Ho Hospital

A Preliminary Study on the Demand and Design of Digital Learning Aids for Special Children With TRIZ and 3D Printing Technology

During the transition phase from early intervention to primary education (4.5 years to 8.11 years), children with special needs may encounter difficulties in using digital learning media. The investigators intend to apply the TRIZ analysis method to enhance children's participation in learning. Additionally, the investigators plan to design a preliminary model of learning aids and conduct a trial.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Detailed Description

The design of digital learning aids for early childhood education for special children to participate in classroom learning is based on the principle of TRIZ analysis combined with the design of 3D printing technology to explore the needs and design of digital apparatus for early childhood education for special children to participate in classroom learning.

A exploratory study. Part 1: Analysis of Systematic Questionnaires. Thirty questionnaires were collected from users of learning devices based on the theoretical basis of ACCESS-FM.The results of the questionnaire are based on the theoretical concept analysis of TRIZ and are used for the preliminary design of learning aids.Part 2: Analysis of Assistive Device Trial. Five school-age children were recruited from the questionnaires for the preliminary design of learning aids. The results are collected for the digital platform performance (writing and typing tests), the ABILHAND-Kids, the Berry-Buktenica Developmental Test of Visual-Motor Integration, Motor Coordination, and the Children's Learning Devices. Motor Integration, Motor Coordination), the Movement Assessment Battery for Children for Children, Second Edition, the Quebec User Evaluation of Satisfaction with Assistive Technology; QUEST) and side effects.

Data Analysis: The performance and side effects of the digital platform operations before and after training were compared using Wilcoxon Signed Ranked Test. SPSS 20.0 was used and the level of statistically significant difference was set at Alpha<0.05.

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan
        • Available
        • Taipei Medical University Shuang Ho Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Analysis of Systematic Questionnaires part

  • the caregiver of a child with special needs in early care;
  • the caregiver or child has trouble using electronic devices or needs;
  • the child can cooperate with the full questionnaire;
  • the child with special needs in early care attends school. Analysis of Assistive Device Trial part
  • Special children aged 6 to 9 years who are currently receiving early intervention;
  • Children who experience difficulties or have needs related to using electronic devices;
  • Participants who are able to complete the trial sessions;
  • Special children receiving early intervention who are attending school.

Exclusion Criteria:

Analysis of Systematic Questionnaires part

  • The child is younger than 4.5 years old or older than 9 years old;
  • The caregiver is unable to communicate and read in Chinese.

Analysis of Assistive Device Trial part

  • Children younger than 6 years or older than 9 years of age;
  • Children who are unable to recognize Zhuyin (Bopomofo) phonetic symbols.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Analysis of Systematic Questionnaires
The investigators will classify digital learning devices into four categories: tablets/smartphones, laptops, desktop computers, and digital whiteboards, along with their respective operational accessories. Based on the theoretical foundation of ACCESS-FM, the investigators will design a user questionnaire (Questionnaire I) for learning devices. This questionnaire will include information on the type of digital learning device used, how children use it, the target population, the usage environment, needs and limitations, willingness to use, and acquisition methods. The investigators aim to collect 30 responses.
Combination product: Digital Learning Aids
Recruitment is currently underway for special children undergoing outpatient early intervention. Among the recruited participants, five children between the ages of 6 and 9, who are receiving early intervention, were screened. After obtaining their consent to participate in this study, their basic information was recorded, including gender, age, education, diagnosis, Movement Assessment Battery for Children (MABC-2), Visual-Motor Integration (VMI) test, and Children's ABILHAND questionnaire for manual ability. Once the collection of basic information is completed, a trial of digital aids will be conducted, and a trial feedback questionnaire will be administered. The trial period will consist of a 20-minute session and 2-3 sessions (per week) of home (or therapy room) use.
Experimental: Analysis of Assistive Device Trial
Recruitment is currently underway for special children undergoing outpatient early intervention. Among the recruited participants, five children between the ages of 6 and 9, who are receiving early intervention, were screened. A trial of digital aids will be conducted, and a trial feedback questionnaire will be administered. The trial period will consist of a 20-minute session and 2-3 sessions (per week) of home (or therapy room) use.
Combination product: Digital Learning Aids
Recruitment is currently underway for special children undergoing outpatient early intervention. Among the recruited participants, five children between the ages of 6 and 9, who are receiving early intervention, were screened. After obtaining their consent to participate in this study, their basic information was recorded, including gender, age, education, diagnosis, Movement Assessment Battery for Children (MABC-2), Visual-Motor Integration (VMI) test, and Children's ABILHAND questionnaire for manual ability. Once the collection of basic information is completed, a trial of digital aids will be conducted, and a trial feedback questionnaire will be administered. The trial period will consist of a 20-minute session and 2-3 sessions (per week) of home (or therapy room) use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Handwriting Task
Time Frame: Change from handwriting task at 1 week.

The time and quality required to complete 10 words are measured. The speed (time taken to complete 10 words) and quality (accuracy, legibility, size, exceeding the lines, sufficient and consistent pressure) are recorded.

Typing Test: Three-minute Bopomofo typing test to assess the number of words typed and accuracy.
Change from handwriting task at 1 week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assistive device satisfaction scale
Time Frame: After every writing task at 1 week.
The questionnaire is a subjective self-filling scale for the use of assistive devices, and the visual analog scale 0-10 scale is used. The items include the writing speed, ease of use, comfort, effectiveness, etc.
After every writing task at 1 week.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
ABILHAND-Kids
Time Frame: Change from ABILHAND-Kids at 1 week.
Measures the ability to participate in daily life, the applicable age is 6-15 years old, filled by parents, consciously the degree of difficulty of participating in daily life.
Change from ABILHAND-Kids at 1 week.
Typing test
Time Frame: Change from Typing test at 1 week.
Three-minute phonetic typing test, to see the number of words typed in three minutes and the correct rate.
Change from Typing test at 1 week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Shuang Ho Hospital

Collaborators

Taipei Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 20, 2023

Primary Completion

March 30, 2024

Study Completion

April 30, 2024

Study Registration Dates

First Submitted

June 23, 2023

First Submitted That Met QC Criteria

June 29, 2023

First Posted (Actual)

July 7, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 10, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • TMU-JIRB N202305081

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Digital Learning Aids for Special Children

Clinical Trials on Digital Learning Aids

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe