UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031925 |
|---|---|
| Receipt number | R000036213 |
| Scientific Title | A comparative study on pelvic floor muscle activity of local vibration training and non-vibration training |
| Date of disclosure of the study information | 2018/03/30 |
| Last modified on | 2021/09/28 09:12:38 |
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Basic information
Public title
A comparative study on pelvic floor muscle activity of local vibration training and non-vibration training
Acronym
A comparative study on pelvic floor muscle activity of local vibration training and non-vibration training
Scientific Title
A comparative study on pelvic floor muscle activity of local vibration training and non-vibration training
Scientific Title:Acronym
A comparative study on pelvic floor muscle activity of local vibration training and non-vibration training
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
When we carry out rehabilitation, examin a new exercise method to the pelvic floor muscle
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
maximam Muscle activity of pelvic floor muscle(MVC), the sensations that result from different contractions or tensions of the muscles(VAS)
Key secondary outcomes
ICIQ-SF, muscle activity of Rectus abdominis muscle, rectus femoris, gluteus maximus(before and after intervention),muscle activity of pelvic floor muscle, Rectus abdominis muscle, rectus femoris
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
(1)concentric exercise of pelvic floor muscle
(2)exercise with vibration
(3)5 min
(4)pelvic floor muscle, rectus abdominis muscle, rectus femoris muscle, gluteus maximus
Interventions/Control_2
(1)concentric exercise of pelvic floor muscle
(2)exercise
(3)5 min
(4)pelvic floor muscle, rectus abdominis muscle, rectus femoris muscle, gluteus maximus
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The person who belongs to Hiroshima University or lives in Hiroshima city (at the time of informed consent)
2. The person who is not incontinence of urine
Key exclusion criteria
1. The person who is incontinence of urine
2. Interested person of the person in charge
3. The person who admitted that the study person in charge was inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Urabe |
Organization
Hiroshima University graduate school
Division name
Biomedical and health sciences
Zip code
7348551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5405
yurabe@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Komiya |
Organization
Hiroshima University graduate school
Division name
Biomedical and health sciences
Zip code
7348551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
080-6923-3538
Homepage URL
makoto-komiya@hiroshima-u.ac.jp
Sponsor or person
Institute
Graduate school of Biomedical and Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Graduate school of Biomedical and Health Sciences
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
Graduate school of Biomedical and Health Sciences
Address
1-2-3, Kasumi, Minami-ku
Tel
0822575405
makoto-komiya@hiroshima-u.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
| 2018 | Year | 03 | Month | 30 | 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
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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 27 | Day |
Last modified on
| 2021 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036213
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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