UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057000 |
|---|---|
| Receipt number | R000065142 |
| Scientific Title | Functional analysis of socks using inertial sensors built into the insole |
| Date of disclosure of the study information | 2025/02/12 |
| Last modified on | 2025/02/11 21:45:09 |
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Basic information
Public title
Functional analysis of socks using inertial sensors built into the insole
Acronym
Functional evaluation of socks
Scientific Title
Functional analysis of socks using inertial sensors built into the insole
Scientific Title:Acronym
Functional evaluation of socks
Region
| Japan |
Condition
Condition
Leg fatigue
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An insole-embedded inertial sensor finds indicators of changes in foot fatigue. The goal is to identify differences in the degree of fatigue due to differences in the socks worn.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Data of angular velocity and acceleration from insole built-in inertial sensor
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
A person performs factory labor work for a day wearing socks whose product name is "Rakuatsu" (easy pressure).
Interventions/Control_2
Wear long socks and do factory labor work for a day.
Interventions/Control_3
Wear short socks and do factory labor work for a day.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
This is for employees working at the Takaoka headquarters of Sukeno Co.
The number of people to be recruited is 20, regardless of age or gender.
Key exclusion criteria
People who are being treated for orthopedic conditions such as cervical myelopathy, lumbar spinal canal stenosis, osteoarthritis of the hip, osteoarthritis of the knee, and chronic low back pain, as well as other internal medicine conditions, will be interviewed by a doctor when obtaining consent to participate, and if it is judged that their walking or participation in this study will be affected, they will be excluded. Furthermore, those who have obtained written consent to participate in the study will be asked to participate.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Akita |
Organization
Institute of Science Tokyo
Division name
Department of Clinical Anatomy
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5390
akita.fana@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Akita |
Organization
Institute of Science Tokyo
Division name
Department of Clinical Anatomy
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5390
Homepage URL
akita.fana@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
SUKENO CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-4547
syomu1.adm@tmd.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
| 2025 | Year | 02 | Month | 12 | 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
| 2025 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | 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
| 2025 | Year | 02 | Month | 11 | Day |
Last modified on
| 2025 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065142
