UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061915 |
|---|---|
| Receipt number | R000070845 |
| Scientific Title | A Study on Clothing-Related Challenges and Clothing Microclimate in Individuals with Upper Limb Functional Disabilities |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/15 16:39:06 |
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Basic information
Public title
A Study on Clothing-Related Challenges and the Clothing Environment in Individuals with Upper Limb Disabilities
Acronym
Study on Clothing Environment in People with Upper Limb Disabilities
Scientific Title
A Study on Clothing-Related Challenges and Clothing Microclimate in Individuals with Upper Limb Functional Disabilities
Scientific Title:Acronym
Study on Clothing-Related Challenges and Clothing Microclimate in Individuals with Upper Limb Functional Disabilities
Region
| Japan |
Condition
Condition
Individuals with upper limb amputation, upper limb disarticulation, or brachial plexus injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in clothing microclimate (temperature and humidity) and subjective evaluations of clothing comfort
Key secondary outcomes
Difficulties and needs related to daily life and clothing-related activities among individuals with upper limb disabilities
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
| Behavior,custom |
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.
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
| 99 | 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 sample size
20
Research contact person
Name of lead principal investigator
| 1st name | CHINAMI |
| Middle name | |
| Last name | KOMATSU |
Organization
Kio University
Division name
Graduate School of Health Science
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL
0745-54-1601
c.komatsu@kio.ac.jp
Public contact
Name of contact person
| 1st name | CHINAMI |
| Middle name | |
| Last name | KOMATSU |
Organization
Kio University
Division name
Graduate School of Health Science
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL
0745-54-1601
Homepage URL
c.komatsu@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio 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
Kio University
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara, Japan
Tel
0745-54-1601
c.komatsu@kio.ac.jp
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 | 01 | 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 | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | 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 | 06 | Month | 15 | Day |
Last modified on
| 2026 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070845
