UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032915 |
|---|---|
| Receipt number | R000037529 |
| Scientific Title | 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 | 2023/07/07 00:41:26 |
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Basic information
Public title
Verification of the effect of balance practice by tsuku-balance protocol for sports athletes
Acronym
Verification of the effect of balance practice by tsuku-balance protocol for sports athletes
Scientific Title
Verification of the effect of balance practice by tsuku-balance protocol for sports athletes
Scientific Title:Acronym
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
| 1st name | Yasushi |
| Middle name | |
| Last name | Hada |
Organization
University of Tsukuba Hospital
Division name
Department of Rehabilitation Medicine
Zip code
3058576
Address
2-1-1 Tenkubo Tsukuba, Ibaraki prefecture
TEL
0298-53-3795
y-hada@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Tsubaki |
Organization
University of Tsukuba Hospital
Division name
Department of Rehabilitation Medicine
Zip code
3058576
Address
2-1-1 Tenkubo Tsukuba, Ibaraki prefecture
TEL
0298-53-3795
Homepage URL
tsubaki-2308@gmail.com
Sponsor or person
Institute
Department of Rehabilitation Medicine, University of Tsukuba Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
University of Tsukuba Hospital
Address
2-1-1 Tenkubo Tsukuba, Ibaraki prefecture
Tel
0298533795
tsubaki2308@gmail.com
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 |
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
| 2018 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2018 | Year | 06 | Month | 07 | Day |
Last modified on
| 2023 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037529
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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