UMIN-CTR Clinical Trial

Basic information
Public title	The effectiveness of similar barefoot walking on physical balance function and walking ability.
Acronym	The effectiveness of similar barefoot walking on physical balance function and walking ability.
Scientific Title	The effectiveness of similar barefoot walking on physical balance function and walking ability.
Scientific Title:Acronym	The effectiveness of similar barefoot walking on physical balance function and walking ability.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to investigate the effectiveness of walking close to barefoot on TFS, physical balance function and walking ability.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	physical balance function walking ability
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Factorial
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	Behavior,custom
Interventions/Control_1	Control phase: Normal daily life for 4 weeks
Interventions/Control_2	Intervention phase: 6 weeks of daily life with 5 finger shoes
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	25 years-old >=
Gender	Male and Female
Key inclusion criteria	Participants who 1) are aged over 20 years old . 2) do not exercise regularly. 3) do not have problem with the physical activity associated with the measurement. 4) provided informed consent.
Key exclusion criteria	Participants who 1) are prohibited from exercising by doctors. 2) have obstacle about gait function.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Taketaka Middle name Last name Hara
Organization	Shimane University
Division name	Faculty of Education
Zip code	6908504
Address	1060 Nishikawatsu-cho, Matsue, Shimane
TEL	0852-32-6340
Email	thara@edu.shimane-u.ac.jp

Public contact
Name of contact person	1st name Taketaka Middle name Last name Hara
Organization	Shimane University
Division name	Faculty of Education
Zip code	6908504
Address	1060 Nishikawatsu-cho, Matsue, Shimane
TEL	0852-32-6340
Homepage URL
Email	thara@edu.shimane-u.ac.jp

Sponsor
Institute	Shimane University
Institute
Department

Funding Source
Organization	The descent and Ishimoto memorial foundation for the promotion of sports science
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shimane University Institutional Committee on Ethics
Address	89-1 Enya-cyo, Izumo-city, Shimane
Tel	0853-20-2515
Email	kenkyu@med.shimane-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	2019 Year 08 Month 26 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	Completed
Date of protocol fixation	2017 Year 10 Month 23 Day
Date of IRB	2017 Year 10 Month 23 Day
Anticipated trial start date	2017 Year 10 Month 23 Day
Last follow-up date	2020 Year 03 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	2019 Year 08 Month 26 Day
Last modified on	2020 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043109