UMIN-CTR Clinical Trial

Basic information
Public title	Factors influencing pelvic tilt in the sitting position-Changes in how the diaper is worn-
Acronym	Examination of pelvic inclination factor
Scientific Title	Examination of the factor affecting the pelvic alignment in the sitting posture-Change by the wearing method of the diaper-
Scientific Title:Acronym	Examination of factors of pelvic alignment
Region	Japan

Condition
Condition	In order to examine the effect of wearing a diaper on the sitting position, we first investigate whether there are any factors that affect healthy adults.
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The frequency of dysuria among elderly people in Japan is high. About 78% of men and women over 60 years old and 27 million have some urination symptoms. About 5 million people now have urinary incontinence. It is estimated that it will reach 10 million people. Many elderly people are forced to use diapers. Even in this hospital, there is a reality that there are many diaper users because of the function of an acute hospital. In recent years, from the viewpoint of getting out of bed early, even if a diaper is worn, active sitting and wheelchair riding have been carried out. However, there is a report that the sitting posture changes greatly by reducing the mobility of the hip joint and pelvis depending on the wearing method of diapers (especially tape type diapers). There is no uniform intervention in our hospital. For this reason, it is considered necessary to verify changes in sitting pressure and posture alignment in the sitting position due to differences in the method of wearing the tape-type diaper. The purpose of this study is to elucidate the effects of changing the sitting pressure, pelvic tilt, pelvic-vertebral alignment, etc., on the sitting posture depending on how the diaper is worn, and to help advance high-quality bed removal.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Gyro measurement by Horizon
Key secondary outcomes	Measurement of total contact area and center-of-gravity movement range by sitting pressure sensor (SR soft vision), 10-point evaluation of research subjects by questionnaire

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Diaper cross stop > Horizon is used to measure the maximum pelvic tilt and maximum anteversion. At the same time, the total contact area and center of gravity movement range are also measured using SR Soft Vision. Subjective evaluation at the time of wearing > Diaper parallel locking > Horizon maximum posterior tilt and maximum forward tilt are measured using horizon. At the same time, the total contact area and center of gravity movement range are also measured using SR Soft Vision. Subjective evaluation at the time of wearing
Interventions/Control_2	Diaper parallel stop > maximal posterior tilt and maximum forward tilt are measured using horizon. At the same time, the total contact area and center of gravity movement range are also measured using SR Soft Vision. Perform subjective evaluation at the time of wearing > Diaper crossing > Horizon maximum posterior tilt and maximum forward tilt using horizon. At the same time, the total contact area and center of gravity movement range are also measured using SR Soft Vision. Subjective evaluation at the time of wearing
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy adult men and women
Key exclusion criteria	Those who have cognitive and intellectual disabilities and who do not agree with the research purpose. When there is obvious joint contracture such as extremities.
Target sample size	23

Research contact person
Name of lead principal investigator	1st name Chiaki Middle name Last name Satou
Organization	Shimane University Hospital
Division name	Rehabilitation Department
Zip code	693-8501
Address	89-1 Shioji-cho, Izumo-shi, Shimane
TEL	0853202457
Email	y8r24p@gmail.com

Public contact
Name of contact person	1st name Chiaki Middle name Last name Satou
Organization	Shimane University Hospital
Division name	Rehabilitation Department
Zip code	6938501
Address	89-1 Shioji-cho, Izumo-shi, Shimane
TEL	0853202457
Homepage URL
Email	y8r24p@gmail.com

Sponsor
Institute	Shimane University Hospital Rehabilitation Department
Institute
Department

Funding Source
Organization	Shimane University Hospital Hospital Medical Education Research Center
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	N/A
Address	N/A
Tel	N/A
Email	N/A

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	島根大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 08 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	23
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	2018 Year 01 Month 18 Day
Date of IRB	2019 Year 01 Month 18 Day
Anticipated trial start date	2019 Year 02 Month 12 Day
Last follow-up date	2019 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 08 Day
Last modified on	2019 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042897