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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032908
Receipt No. 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

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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
Email 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
Email sportssec@hss.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Medicine for Sports and Performing Arts
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037523

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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