Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061915) titled 'A Study on Clothing-Related Challenges and the Clothing Environment in Individuals with Upper Limb Disabilities' on July 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Kio University
Condition:
Condition - Individuals with upper limb amputation, upper limb disarticulation, or brachial plexus injury
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To improve the quality of life (QOL) of individuals with upper limb amputation, upper limb disarticulation, or brachial plexus injury by identifying clothing-related challenges in daily life and evaluating a self-management method involving placing a towel under the axilla to alleviate clothing-related discomfort from physiological, subjective, and clothing science perspectives.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Participants will perform a self-management method involving placing a towel under the axilla, and the effects on clothing microclimate (temperature and humidity) and clothing comfort will be evaluated.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Individuals with upper limb amputation, upper limb disarticulation, or brachial plexus injury, as well as healthy adults
Key exclusion criteria - Participants who meet any of the following criteria will be excluded from the study:
Individuals who are unable to provide voluntary informed consent
Individuals for whom written informed consent cannot be obtained
Individuals who are judged by the principal investigator to be inappropriate for participation in the study
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 12 Day
Anticipated trial start date - 2026 Year 07 Month 01 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070845
Disclaimer: Curated by HT Syndication.