Digital Learning Aids for Special ChildrenNCT05935462
A Preliminary Study on Digital Learning Aids for Special Children With TRIZ and 3D Printing Technology
A study testing Digital Learning Aids in people with Digital Learning Aids for Special Children, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Digital Learning Aids for Special Children
- What is being tested?
- Digital Learning Aids
- How many people
- Not given
- Where
- 1 siteTaiwan
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
- Available
Taipei Medical University Shuang Ho Hospital
New Taipei City
Fen-Ling Kuo, Master, +886222490088 ext. 1624, 08655@s.tmu.edu.tw
Po Yin Chen, Doctor, +886227361661 ext. 6311, poyin1128@tmu.edu.tw
About this study
Official title: 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.
Read the 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.
- Being tested
- Digital Learning Aids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Learning AidsCombination product
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Digital Learning Aids for Special ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935462
- Sponsor's protocol ID
- TMU-JIRB N202305081
- Status last verified
- Nov 2024
- First submitted
- 23 Jun 2023
- Last updated
- 16 Dec 2024
- Results posted
- No
Publications
Amaral DS, Duarte ALBP, Barros SS, Cavalcanti SV, Ranzolin A, Leite VMM, Dantas AT, Oliveira ASCRC, Santos PS, Silva JCA, Marques CDL. Assistive devices: an effective strategy in non-pharmacological treatment for hand osteoarthritis-randomized clinical trial. Rheumatol Int. 2018 Mar;38(3):343-351. doi: 10.1007/s00296-017-3892-1. Epub 2017 Nov 28.
PubMed 29185087Baronio G, Harran S, Signoroni A. A Critical Analysis of a Hand Orthosis Reverse Engineering and 3D Printing Process. Appl Bionics Biomech. 2016;2016:8347478. doi: 10.1155/2016/8347478. Epub 2016 Aug 9.
PubMed 27594781Funch A, Kruse NB, la Cour K, Peoples H, Waehrens EE, Brandt A. The association between having assistive devices and activities of daily living ability and health-related quality of life: An exploratory cross-sectional study among people with advanced cancer. Eur J Cancer Care (Engl). 2019 May;28(3):e13002. doi: 10.1111/ecc.13002. Epub 2019 Feb 10.
PubMed 30740805Keller M, Guebeli A, Thieringer F, Honigmann P. Overview of In-Hospital 3D Printing and Practical Applications in Hand Surgery. Biomed Res Int. 2021 Mar 26;2021:4650245. doi: 10.1155/2021/4650245. eCollection 2021.
PubMed 33855068Long TM, Woolverton M, Perry DF, Thomas MJ. Training needs of pediatric occupational therapists in assistive technology. Am J Occup Ther. 2007 May-Jun;61(3):345-54. doi: 10.5014/ajot.61.3.345.
PubMed 17569392Ma HI, Hwang WJ, Tsai PL, Hsu YW. The effect of eating utensil weight on functional arm movement in people with Parkinson's disease: a controlled clinical trial. Clin Rehabil. 2009 Dec;23(12):1086-92. doi: 10.1177/0269215509342334.
PubMed 19906764McDonald SS, Levine D, Richards J, Aguilar L. Effectiveness of adaptive silverware on range of motion of the hand. PeerJ. 2016 Feb 15;4:e1667. doi: 10.7717/peerj.1667. eCollection 2016.
PubMed 26893960Roda-Sales A, Vergara M, Sancho-Bru JL, Gracia-Ibanez V, Jarque-Bou NJ. Effect on hand kinematics when using assistive devices during activities of daily living. PeerJ. 2019 Oct 8;7:e7806. doi: 10.7717/peerj.7806. eCollection 2019.
PubMed 31608177Skymne C, Dahlin-Ivanoff S, Claesson L, Eklund K. Getting used to assistive devices: ambivalent experiences by frail elderly persons. Scand J Occup Ther. 2012 Mar;19(2):194-203. doi: 10.3109/11038128.2011.569757. Epub 2011 May 2.
PubMed 21534712
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study on the Demand and Design of Digital Learning Aids for Special Children With TRIZ and 3D Printing Technology
- ClinicalTrials.gov ID
- NCT05935462
- Acronym / sponsor ID
- TMU-JIRB N202305081
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Collaborators
- Taipei Medical University
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Learning AidsRecruitment 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. | Combination product | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Results publication: PubMed 29185087Amaral DS, Duarte ALBP, Barros SS, Cavalcanti SV, Ranzolin A, Leite VMM, Dantas AT, Oliveira ASCRC, Santos PS, Silva JCA, Marques CDL. Assistive devices: an effective strategy in non-pharmacological treatment for hand osteoarthritis-randomized clinical trial. Rheumatol Int. 2018 Mar;38(3):343-351. doi: 10.1007/s00296-017-3892-1. Epub 2017 Nov 28.
- Results publication: PubMed 27594781Baronio G, Harran S, Signoroni A. A Critical Analysis of a Hand Orthosis Reverse Engineering and 3D Printing Process. Appl Bionics Biomech. 2016;2016:8347478. doi: 10.1155/2016/8347478. Epub 2016 Aug 9.
- Results publication: PubMed 30740805Funch A, Kruse NB, la Cour K, Peoples H, Waehrens EE, Brandt A. The association between having assistive devices and activities of daily living ability and health-related quality of life: An exploratory cross-sectional study among people with advanced cancer. Eur J Cancer Care (Engl). 2019 May;28(3):e13002. doi: 10.1111/ecc.13002. Epub 2019 Feb 10.
- Results publication: PubMed 33855068Keller M, Guebeli A, Thieringer F, Honigmann P. Overview of In-Hospital 3D Printing and Practical Applications in Hand Surgery. Biomed Res Int. 2021 Mar 26;2021:4650245. doi: 10.1155/2021/4650245. eCollection 2021.
- Results publication: PubMed 17569392Long TM, Woolverton M, Perry DF, Thomas MJ. Training needs of pediatric occupational therapists in assistive technology. Am J Occup Ther. 2007 May-Jun;61(3):345-54. doi: 10.5014/ajot.61.3.345.
- Results publication: PubMed 19906764Ma HI, Hwang WJ, Tsai PL, Hsu YW. The effect of eating utensil weight on functional arm movement in people with Parkinson's disease: a controlled clinical trial. Clin Rehabil. 2009 Dec;23(12):1086-92. doi: 10.1177/0269215509342334.
- Results publication: PubMed 26893960McDonald SS, Levine D, Richards J, Aguilar L. Effectiveness of adaptive silverware on range of motion of the hand. PeerJ. 2016 Feb 15;4:e1667. doi: 10.7717/peerj.1667. eCollection 2016.
- Results publication: PubMed 31608177Roda-Sales A, Vergara M, Sancho-Bru JL, Gracia-Ibanez V, Jarque-Bou NJ. Effect on hand kinematics when using assistive devices during activities of daily living. PeerJ. 2019 Oct 8;7:e7806. doi: 10.7717/peerj.7806. eCollection 2019.
- Results publication: PubMed 21534712Skymne C, Dahlin-Ivanoff S, Claesson L, Eklund K. Getting used to assistive devices: ambivalent experiences by frail elderly persons. Scand J Occup Ther. 2012 Mar;19(2):194-203. doi: 10.3109/11038128.2011.569757. Epub 2011 May 2.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Learning Aids in people with Digital Learning Aids for Special Children, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fen-Ling Kuo, Master (+886222490088 ext. 1624, 08655@s.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05935462, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.