UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061658 |
|---|---|
| Receipt number | R000070537 |
| Scientific Title | A Study on the Clinical Utility of Quantitative Assessment Using Tactile Sensors in Healthy Adults and Patients with Lymphedema |
| Date of disclosure of the study information | 2026/05/22 |
| Last modified on | 2026/05/22 14:55:58 |
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Basic information
Public title
A Study on the Quantitative Evaluation of Skin Softness in Healthy Adults and Patients with Lymphedema Using Tactile Sensors
Acronym
A Study on the Assessment of Skin Softness
Scientific Title
A Study on the Clinical Utility of Quantitative Assessment Using Tactile Sensors in Healthy Adults and Patients with Lymphedema
Scientific Title:Acronym
A Study on the Clinical Utility of Tactile Sensors
Region
| Japan |
Condition
Condition
Healthy adults
Patients with lymphedema
Classification by specialty
| Breast surgery | Obstetrics and Gynecology | Rehabilitation medicine |
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the reliability and clinical utility of a tactile sensor developed by a collaborating research institution as a method for evaluating the effectiveness of skin care for patients with lymphedema.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement values from the tactile sensor
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy Adults
1. Individuals who, prior to participating in this study, received a thorough explanation and provided written informed consent of their own free will based on a full understanding of the study
2. Individuals who are 18 years of age or older
3. Individuals whose general physical condition is stable and who are capable of independent postural and motor functions while in bed.
Inpatients or outpatients receiving lymphedema treatment at the Department of Rehabilitation, Fujita Health University Hospital
1. Participants who, prior to participating in this study, have provided written informed consent of their own free will or whose legal representative has provided written informed consent on their behalf after receiving a thorough explanation and demonstrating a full understanding of the study.
2. Participants who are 18 years of age or older.
3. Participants whose general medical condition is stable and who are capable of independent positioning and movement in bed.
Key exclusion criteria
Healthy adults
1. Those who have difficulty understanding instructions
2. Those who require assistance with bedside positioning and movements
3. Any other cases deemed inappropriate by the principal researcher or co-researchers
Inpatients or outpatients receiving lymphedema treatment at the Department of Rehabilitation, Fujita Health University Hospital
1. Those who have difficulty understanding instructions
2. Those who require assistance with bedside positioning and movements
3. Any other cases deemed inappropriate by the principal researcher or co-researchers
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2167
yootaka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Soichiro |
| Middle name | |
| Last name | Koyama |
Organization
Fujita Health University
Division name
Faculty of Rehabilitation, School of Health Sciences
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2167
Homepage URL
koyamas@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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 | 05 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no
Management information
Registered date
| 2026 | Year | 05 | Month | 22 | Day |
Last modified on
| 2026 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070537
