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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032915
Receipt No. R000037529
Official scientific title of the study Verification of the effect of balance practice by tsuku-balance protocol for sports athletes
Date of disclosure of the study information 2018/06/08
Last modified on 2018/06/15

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Basic information
Official scientific title of the study Verification of the effect of balance practice by tsuku-balance protocol for sports athletes
Title of the study (Brief title) Verification of the effect of balance practice by tsuku-balance protocol for sports athletes
Region
Japan

Condition
Condition Healthy person
Classification by specialty
Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For the rugby athlete, dynamic balance ability was improved by balancing practice using tsuku - balance protocol, but it is reported that the balance characteristics differ for each sports competition, possibility that a difference in intervention effect may be caused by objective competition Can be considered.
Therefore, in this study, we consider the balance exercise intervention effect by the tsuku-balance protocol for sports athletes (figure skating, judo, rugby) with different physical characteristics and athletic characteristics of athlete from the rugby athlete, so that tsuku- It is aimed to verify the usefulness and versatility of the balance protocol and to examine differences in intervention effect by target competition.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dynamic balance evaluation using center of gravity swaymeter
Key secondary outcomes Grip strength, single leg standing hold time, body composition

Base
Study type Interventional

Study design
Basic design Cross-over
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 Balance practice with the tsuku-balance protocol total of 15 times, twelve minutes a day, five times a week, three weeks
Interventions/Control_2 Normally exercises only
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
5 years-old <=
Age-upper limit
30 years-old >=
Gender Male and Female
Key inclusion criteria 1) There is no vision disorder and limb movement disorder
2) There are no remarkable exerciser diseases such as fractures and ligament injuries in the trunk and lower limbs
3) There is no peripheral neuropathy and upright posture is possible on the spot
4) There is no history of dizziness / equilibrium dysfunction and experience of fall accident
5) Walking and daily life are independent
Key exclusion criteria 1) Persons suffering from impairment due to trauma etc. during intervention
2) Person who did not obtain consent of principal in this research, in case of minority by parental authority
Target sample size 30

Research contact person
Name of lead principal investigator Yasushi Hada
Organization University of Tsukuba Hospital
Division name Department of Rehabilitation Medicine
Address 2-1-1 Tenkubo Tsukuba, Ibaraki prefecture
TEL 0298-53-3795
Email y-hada@md.tsukuba.ac.jp

Public contact
Name of contact person Takumi Tsubaki
Organization University of Tsukuba Hospital
Division name Department of Rehabilitation Medicine
Address 2-1-1 Tenkubo Tsukuba, Ibaraki prefecture
TEL 0298-53-3795
Homepage URL
Email tsubaki-2308@gmail.com

Sponsor
Institute Department of Rehabilitation Medicine, University of Tsukuba Hospital
Institute
Department

Funding Source
Organization no
Organization
Division
Category of Funding Organization Other
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 06 Month 08 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 06 Month 18 Day
Anticipated trial start date
2018 Year 06 Month 24 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 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037529

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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