UMIN-CTR Clinical Trial

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
Email	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
Email	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
Email	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
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

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