UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050755 |
|---|---|
| Receipt number | R000057487 |
| Scientific Title | Fundamental Study of draw-in maneuver for the Prevention of Low Back Pain and Urinary Leakage |
| Date of disclosure of the study information | 2023/04/03 |
| Last modified on | 2023/04/03 16:04:27 |
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Basic information
Public title
Fundamental Study of the Effects of Maintaining Muscle Contraction of the Trunk during Movement on Low Back Pain and Urinary Leakage
Acronym
Fundamental Study of the Effects of Maintaining Muscle Contraction of the Trunk during Movement on Low Back Pain and Urinary Leakage
Scientific Title
Fundamental Study of draw-in maneuver for the Prevention of Low Back Pain and Urinary Leakage
Scientific Title:Acronym
Fundamental Study of draw-in maneuver for the Prevention of Low Back Pain and Urinary Leakage
Region
| Japan |
Condition
Condition
health adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the basic data and to examine the effect of Draw-in maneuver (DI), which reduces abdominal circumference, on the prevention of back pain and urinary leakage by applying it to continuous standing and lifting movements.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between postural change and abdominal circumference.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3D motion analysis, electromyography, Same measurement 4 weeks after Draw in mastery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Wearing a draw in feedback belt that detects a 2 cm decrease in abdominal circumference, the subjects stood up and squatted 10 times in the morning and afternoon and for at least 20 minutes in daily activities.
Interventions/Control_2
the subjects stood up and squatted 10 times in the morning and afternoon
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Heath adults
Key exclusion criteria
Subjects with spinal disorders such as spinal fracture, herniated disc, etc., those with complaints of back pain, lower limb disorders such as fracture of femur, lower leg bone, meniscus, knee joint, ligament injury, etc., those with a history of surgery, and those who are undergoing urologic treatment. Subjests undergoing urological examination
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Ota |
Organization
Seijoh university
Division name
Dept. of Rehabilitation
Zip code
476-8588
Address
2-172, Fukinodai, Tokai, Aichi
TEL
052-601-6000
ota-s@seijoh-u.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Ota |
Organization
Seijoh university
Division name
Dept. of Rehabilitation
Zip code
476-8588
Address
2-172, Fukinodai, Tokai, Aichi
TEL
052-601-6000
Homepage URL
ota-s@seijoh-u.ac.jp
Sponsor or person
Institute
Seijoh university
Institute
Department
Personal name
Funding Source
Organization
ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seijoh university
Address
2-172, Fukinodai, Tokai, Aichi
Tel
052-601-6000
kenkyu-rinri@seijoh-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
| 2023 | Year | 04 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 04 | Month | 03 | Day |
Last modified on
| 2023 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057487
| 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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