UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049343 |
|---|---|
| Receipt number | R000056196 |
| Scientific Title | Change in Circumferential Diameter of Amputated Female Thighs During the Menstrual Cycle |
| Date of disclosure of the study information | 2022/10/27 |
| Last modified on | 2022/10/27 14:36:17 |
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Basic information
Public title
Change in Circumferential Diameter of Amputated Female Thighs During the Menstrual Cycle
Acronym
Change in Circumferential Diameter of Amputated Female Thighs During the Menstrual Cycle
Scientific Title
Change in Circumferential Diameter of Amputated Female Thighs During the Menstrual Cycle
Scientific Title:Acronym
Change in Circumferential Diameter of Amputated Female Thighs During the Menstrual Cycle
Region
| Japan |
Condition
Condition
trans-femoral amputation
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using a 3D scanner for female femoral amputees and normal women to determine the amount of change in circumferential diameter of the transection by menstrual cycle.
Basic objectives2
Others
Basic objectives -Others
Females are more prone to diurnal and interdiurnal variation than males, and have a greater change in the circumference of the ablation. This can lead to socket failure, which may require adjustment or remanufacturing. Frequent adjustment leads to a decrease in the amputee's quality of life. However, few previous reports have evaluated and analyzed the diurnal variation in female amputees and the diurnal variation in menstrual cycle changes, and prosthetists have had difficulty in dealing with these issues. The purpose of this study is to clarify the diurnal variation of the circumference of the femoral amputee by menstrual cycle using a 3D scanner, aiming to establish a simpler measurement method and to improve the reliability of the measurement. The results of this study will be of great significance to both amputees and prosthetists, and will assist in socket fitting for female femoral amputees.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Thigh measurement using 3D scanner
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-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
| Other |
Interventions/Control_1
Thigh measurement using 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
| 21 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Relatively stable menstrual cycle and no edematous disease
Key exclusion criteria
Those who do not consent as research subjects with respect to their free will.
Target sample size
15
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
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-257-4606
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
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
09078465972
Homepage URL
miki-sato@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
025-257-4606
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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 27 | 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
15
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
| 2021 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 10 | Month | 27 | Day |
Last modified on
| 2022 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056196
