UMIN-CTR Clinical Trial

Basic information
Public title	The Effect of Diurnal and Inter-Diurnal Variation in the Gender of Prosthetic Leg Users on the Change in Circumferential Diameter of Broken Ends
Acronym	The Effect of Diurnal and Inter-Diurnal Variation in the Gender of Prosthetic Leg Users on the Change in Circumferential Diameter of Broken Ends
Scientific Title	The Effect of Diurnal and Inter-Diurnal Variation in the Gender of Prosthetic Leg Users on the Change in Circumferential Diameter of Broken Ends
Scientific Title:Acronym	The Effect of Diurnal and Inter-Diurnal Variation in the Gender of Prosthetic Leg Users on the Change in Circumferential Diameter of Broken Ends
Region	Japan

Condition
Condition	artificial leg user
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examining the Effects of Diurnal and Inter-Diurnal Variation in the Gender of Prosthetic Foot Users on the Change in Circumferential Diameter of Broken Ends
Basic objectives2	Others
Basic objectives -Others	Female users are more prone to diurnal and interdiurnal variations and to greater changes in the circumferential diameter of the ablated end compared to male users. 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. In this study, female and male amputees were asked to evaluate the diurnal and inter diurnal changes in the circumference of their prostheses by means of a subjective evaluation questionnaire, and the effects of diurnal and inter diurnal changes on the circumference of their prostheses were examined. This will be of great significance to both amputees and prosthetists.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Questionnaire Evaluation
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	Other
Interventions/Control_1	questionnaire survey
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	73 years-old >=
Gender	Male and Female
Key inclusion criteria	trans-tibial amputation and trans-femoral amputation user
Key exclusion criteria	If you do not intend to participate voluntarily
Target sample size	19

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	025-257-4606
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	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	19
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=R000056195