UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062570 |
|---|---|
| Receipt number | R000071620 |
| Scientific Title | The Effect of Differences in Sock Materials on Numbness after Seiza in Healthy Adults: A Crossover Study |
| Date of disclosure of the study information | 2026/09/10 |
| Last modified on | 2026/09/10 16:15:39 |
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Basic information
Public title
The effect of different sock materials on numbness in healthy adults
Acronym
Research on Sock Materials and Foot Numbness
Scientific Title
The Effect of Differences in Sock Materials on Numbness after Seiza in Healthy Adults: A Crossover Study
Scientific Title:Acronym
A crossover trial on foot numbness after seiza based on sock material
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
his study aims to investigate the effect of sock material differences on numbness by having healthy adults perform seiza (traditional Japanese sitting on heels) while wearing socks made of different materials, and comparing the degree of numbness that occurs after seiza
Basic objectives2
Others
Basic objectives -Others
Evaluation of the effect of differences in sock materials on numbness after Seiza (traditional Japanese sitting on heels) in healthy adults
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluate the degree of lower limb numbness after sitting on one's heels (seiza) for 30 minutes while wearing each sock material using a Visual Analog Scale (VAS), and compare the results among the materials.
Key secondary outcomes
Walking stability after seiza (traditional Japanese kneeling) wearing various sock materials is evaluated using the Timed Up and Go test (TUG). Additionally, ankle circumference and maximum calf circumference are measured to assess their relationship with the compression conditions caused by the sock materials.
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants wear four types of socks made mainly of cotton, polyester, wool, or silk on separate days. In each condition, participants maintain the seiza sitting position for 30 minutes, followed by assessment of numbness and walking function.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 20 years or older.
Individuals with a foot size of 22-25 cm.
Individuals who are able to maintain the seiza sitting position for 30 minutes and participate in the subsequent walking assessment.
Key exclusion criteria
Individuals with numbness, pain, or sensory disturbance in the lower extremities.
Individuals with a history of diabetes mellitus, peripheral neuropathy, spinal disorders, orthopedic disorders, or other conditions that may affect lower-extremity sensation.
Individuals with abnormalities of lower-extremity circulation, such as peripheral arterial disease, deep vein thrombosis, or edema.
Individuals who are prone to severe pain or discomfort while sitting in the seiza position.
Individuals who are pregnant or may be pregnant.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Rina |
| Middle name | |
| Last name | Torii |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Anesthesiology
Zip code
5698686
Address
2-7 Daigakumachi, Takatsuki City, Osaka 569-8686
TEL
072-683-1221
rina.torii@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Rina |
| Middle name | |
| Last name | Torii |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Anesthesiology
Zip code
569-8686
Address
2-7 Daigakumachi, Takatsuki City, Osaka
TEL
09089567309
Homepage URL
rina.torii@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Rina Torii
Funding Source
Organization
Osaka Medical and Pharmaceutical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University Research Ethics Committee
Address
2-7 Daigaku-machi, Takatsuki, Osaka 569-8686
Tel
072-683-1221
rinri@ompu.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
大阪医科薬科大学
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 10 | 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 | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | 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 | 08 | Month | 13 | Day |
Last modified on
| 2026 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071620
