UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062232 |
|---|---|
| Receipt number | R000071214 |
| Scientific Title | Development and Feasibility Evaluation of a Generative AI-Based Design Support System for User-Led 3D-Printed Assistive Devices |
| Date of disclosure of the study information | 2026/07/14 |
| Last modified on | 2026/07/14 13:36:03 |
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Basic information
Public title
Development and Feasibility Evaluation of a Generative AI-Based Design Support System for User-Led 3D-Printed Assistive Devices
Acronym
Development and Feasibility Evaluation of a 3D-Printed Assistive Device Design Support System
Scientific Title
Development and Feasibility Evaluation of a Generative AI-Based Design Support System for User-Led 3D-Printed Assistive Devices
Scientific Title:Acronym
Development and Feasibility Evaluation of a 3D-Printed Assistive Device Design Support System
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop a system that leverages generative AI to enable users to take an active role in designing assistive devices by inputting their physical conditions and daily living needs, and to examine its feasibility in real-life settings, specifically in terms of acceptability, practicality, and preliminary usefulness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
System Usability Scale
Key secondary outcomes
QUEST 2.0
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Introduction of a Generative AI-Based, User-Led 3D-Printed Assistive Device Design Support System
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals with physical disabilities receiving rehabilitation services
Key exclusion criteria
Individuals who lack sufficient decision-making capacity to participate in the study due to cognitive impairment or higher brain dysfunction
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Kondo |
Organization
Gunma Paz University
Division name
Department of Rehabilitation
Zip code
3700006
Address
1-7-1 Tonya, Takasaki ,Gunma
TEL
0273653366
kenkondoot@gmail.com
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Kondo |
Organization
Gunma Paz University
Division name
Department of Rehabilitation
Zip code
3700006
Address
1-7-1 Tonya, Takasaki ,Gunma
TEL
0273653366
Homepage URL
kenkondoot@gmail.com
Sponsor or person
Institute
Gunma Paz University
Institute
Department
Personal name
Funding Source
Organization
Gunma Paz University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma Paz University Research Ethics Committee
Address
1-7-1 Tonyamachi, Takasaki, Gunma
Tel
0273653366
kenkondoot@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 14 | Day |
Last modified on
| 2026 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071214
