UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032908 |
|---|---|
| Receipt number | R000037523 |
| Scientific Title | The effect toward dynamic stability with Whole Body Vibration Training for healthy subjects |
| Date of disclosure of the study information | 2018/07/15 |
| Last modified on | 2018/06/07 15:45:42 |
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Basic information
Public title
The effect toward dynamic stability with Whole Body Vibration Training for healthy subjects
Acronym
The effect toward dynamic stability with Whole Body Vibration Training for healthy subjects
Scientific Title
The effect toward dynamic stability with Whole Body Vibration Training for healthy subjects
Scientific Title:Acronym
The effect toward dynamic stability with Whole Body Vibration Training for healthy subjects
Region
| Japan |
Condition
Condition
not available
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the acceleration training improves the ability of dynamic stability
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The length of center of pressure trajectory
Key secondary outcomes
The peak value of the vertical ground reaction force
Joint moment of lower extremity
Joint range of motion for lower extremity
Electrical muscular activity of lower extremity
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Group with Whole Body Vibration Training for 12 weeks
(3timesx12weeks, total 36times)
This group performs below exercises on top of Whole Vibration Machine, PowerPlate
1- Marching 30secx2sets
2- Lunge 30secx2xL/R
3- Single Leg Balance 30secx2setsxL/R
4- Squat 30secx2sets
Interventions/Control_2
Group without Whole Body Vibration Training for 12 weeks
(3timesx12weeks, total 36times)
This group performs below exercises on the floor
1- Marching 30secx2sets
2- Lunge 30secx2xL/R
3- Single Leg Balance 30secx2setsxL/R
4- Squat 30secx2sets
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
| 16 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females between age 16 and 59
Key exclusion criteria
Anyone who has
- orthopedic injuries within 12month
- neurological issues effecting one's balance, such as Parkinson's disease, Meniere's disease
- physical issues which can be worsen by whole body vibration (vertigo, detached retina, etc)
- cognitive condition that hinders someone to understand or grasp the meaning and instruction of our experiments
- issues with completing experiments with a risk of falling
- physical issues and not treated after physical check-ups
or anyone who is determined inappropriate to participate by research manager or conductor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Nakata |
Organization
Osaka University Graduate School of Medicine
Division name
Medicine for Sports and Performing Arts
Zip code
Address
2-2 Yamadaoka, Center of Medical Innovation and Translational Research Building, Suita, Osaka, 656-0871, Japan
TEL
06-6210-8439
sportssec@hss.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Nakata |
Organization
Osaka University Graduate School of Medicine
Division name
Medicine for Sports and Performing Arts
Zip code
Address
2-2 Yamadaoka, Center of Medical Innovation and Translational Research Suita, Osaka, 656-0871, Japan
TEL
06-6210-8439
Homepage URL
sportssec@hss.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Medicine for Sports and Performing Arts
Institute
Department
Personal name
Funding Source
Organization
PROTEA JAPAN Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 07 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 07 | Day |
Last modified on
| 2018 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037523
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
