UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057686 |
|---|---|
| Receipt number | R000065918 |
| Scientific Title | Comparison of changes in lower extremity circumference in menstrual circumference change in healthy women |
| Date of disclosure of the study information | 2025/04/22 |
| Last modified on | 2025/04/22 18:02:59 |
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Basic information
Public title
Comparison of changes in lower extremity circumference in menstrual circumference change in healthy women
Acronym
Comparison of changes in lower extremity circumference in menstrual circumference change in healthy women
Scientific Title
Comparison of changes in lower extremity circumference in menstrual circumference change in healthy women
Scientific Title:Acronym
Comparison of changes in lower extremity circumference in menstrual circumference change in healthy women
Region
| Japan |
Condition
Condition
Normal women with normal menstrual cycles
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the amount of change in lower limb circumference in menstrual cycle changes in healthy women Clarification of the amount of change in lower limb circumference in menstrual cycle changes in healthy women
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lower extremity circumference by 3D scanner
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Lower extremity circumference by 3D scanner
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
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
Normal women with normal menstrual cycles
Key exclusion criteria
Irregular menses
Medication due to edema
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Miki |
| Middle name | |
| Last name | Sato |
Organization
Niigata University of Health and Welfare
Division name
Department of Prosthetics & Orthotics and Assistive Technology
Zip code
9503133
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-250-6594
miki-sato@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Sato |
Organization
Niigata University of Health and Welfare
Division name
Department of Prosthetics & Orthotics and Assistive Technology
Zip code
9503133
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-250-6594
Homepage URL
miki-sato@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Sato Miki
Funding Source
Organization
without
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
Niigata University of Health and Welfare
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
Tel
025-250-6594
miki-sato@nuhw.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
状態の選択
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | 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 | 04 | Month | 22 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065918
