UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect toward dynamic stability with Whole Body Vibration Training for healthy subjects
Title of the study (Brief title)	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	Ken Nakata
Organization	Osaka University Graduate School of Medicine
Division name	Medicine for Sports and Performing Arts
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	Ken Nakata
Organization	Osaka University Graduate School of Medicine
Division name	Medicine for Sports and Performing Arts
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 07 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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