UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037641 |
|---|---|
| Receipt number | R000042897 |
| Scientific Title | Examination of the factor affecting the pelvic alignment in the sitting posture-Change by the wearing method of the diaper- |
| Date of disclosure of the study information | 2019/08/08 |
| Last modified on | 2019/08/08 23:06:00 |
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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
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
y8r24p@gmail.com
Sponsor or person
Institute
Shimane University Hospital
Rehabilitation Department
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042897
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| Registered date | File name |
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