UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037801 |
|---|---|
| Receipt number | R000043109 |
| Scientific Title | The effectiveness of similar barefoot walking on physical balance function and walking ability. |
| Date of disclosure of the study information | 2019/08/26 |
| Last modified on | 2020/02/25 17:06:17 |
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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
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
thara@edu.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043109
