UMIN-CTR Clinical Trial

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
Email	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
Email	miki-sato@nuhw.ac.jp

Sponsor
Institute	Niigata University of Health and Welfare
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056196