UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031640 |
|---|---|
| Receipt number | R000035581 |
| Scientific Title | Verification of the effect of WT-LINE(R) shoes and Japanese bone stretch on motor function |
| Date of disclosure of the study information | 2018/03/08 |
| Last modified on | 2020/03/09 15:19:42 |
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Basic information
Public title
Verification of the effect of WT-LINE(R) shoes and Japanese bone stretch on motor function
Acronym
Verification of the effect of WT-LINE(R) shoes and Japanese bone stretch on motor function
Scientific Title
Verification of the effect of WT-LINE(R) shoes and Japanese bone stretch on motor function
Scientific Title:Acronym
Verification of the effect of WT-LINE(R) shoes and Japanese bone stretch on motor function
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effect of WT-LINE(R) shoes and Japanese bone stretch on motor function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Walking speed
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Behavior,custom |
Interventions/Control_1
To wear WT-LINE(R) shoes
To do Japanese Bone Stretch
Interventions/Control_2
To wear shoes for comparison
To do the radio gymnastics.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age is more than 19.
Able to decide to take part into the research by oneself.
Able to wear shoes.
Able to do exercise.
Key exclusion criteria
None
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Sanghong |
| Middle name | |
| Last name | Kim |
Organization
Kyoto Univ.
Division name
Graduate School of Engineering
Zip code
6158510
Address
A4-120 Kyoto University Katsura Nishikyo-ku Kyoto, Japan
TEL
0753832677
kim@cheme.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Sanghong |
| Middle name | |
| Last name | Kim |
Organization
Kyoto University
Division name
Graduate School of Engineering
Zip code
6158510
Address
A4-120 Kyoto University Katsura Nishikyo-ku Kyoto, Japan
TEL
0753832677
Homepage URL
kim@cheme.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Engineering, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
SportsCare Seitai Institute
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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 | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 08 | 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 | 03 | Month | 08 | Day |
Last modified on
| 2020 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035581
