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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000031640 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | Not applicable | ||
Classification by specialty |
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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 |
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Interventions/Control_1 | To wear WT-LINE(R) shoes
To do Japanese Bone Stretch |
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Interventions/Control_2 | To wear shoes for comparison
To do the radio gymnastics. |
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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 |
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Age-upper limit |
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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. |
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Key exclusion criteria | None | |||
Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Graduate School of Engineering, Kyoto University |
Institute | |
Department |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035581 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |