Tokyo, July 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062232) titled 'Development and Feasibility Evaluation of a Generative AI-Based Design Support System for User-Led 3D-Printed Assistive Devices' on July 14.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Gunma Paz University
Condition:
Condition - Stroke
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Introduction of a Generative AI-Based, User-Led 3D-Printed Assistive Device Design Support System
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 Size - 15
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 14 Day
Anticipated trial start date - 2026 Year 10 Month 01 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071214
Disclaimer: Curated by HT Syndication.
