UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007126 |
|---|---|
| Receipt number | R000008382 |
| Scientific Title | The effect to the body by wearing toning shoes: open-label, non-randomaized, single group assignment, shoes trial |
| Date of disclosure of the study information | 2012/01/25 |
| Last modified on | 2013/02/01 10:49:35 |
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Basic information
Public title
The effect to the body by wearing toning shoes: open-label, non-randomaized, single group assignment, shoes trial
Acronym
The effect to the body by wearing toning shoes
Scientific Title
The effect to the body by wearing toning shoes: open-label, non-randomaized, single group assignment, shoes trial
Scientific Title:Acronym
The effect to the body by wearing toning shoes
Region
| Japan |
Condition
Condition
Healthy general population
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects to give to muscle by the toning shoes wearing for a general healthy person.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1)iEMG (mV*sec)
2)iEMG per +(mV)
3)RMS (mV)
Key secondary outcomes
none
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
2 shoes condition experiments walking on the treadmill and on level ground. We measure integral calculus EMGs and perform the comparison between two kinds of shoes.
Interventions/Control_2
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
Female
Key inclusion criteria
1.Healthy general population
2.Height, average 160cm
3.Weight, average 50kg
4.Shoes size, average 24cm
Key exclusion criteria
1.Person without medical history such as bronchial asthma, diabetes, heart troubles, the thyreoid disease.
2.Person judged not to be suitable as a participant from the doctor.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Terushige Kohno |
Organization
St. Marianna University School of Medicine
Division name
Department of Sports Medicine
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL
+81-44-977-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kanaka Yatabe |
Organization
St. Marianna University School of Medicine
Division name
Sports Medicine
Zip code
Address
2-16-1, Sugao , Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japana
TEL
+81-44-977-8111
Homepage URL
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Reebok Japan, adidas Japan K.K.
IRB Contact (For public release)
Organization
Address
Tel
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
聖マリアンナ医科大学スポーツ医学講座（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 25 | 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
| 2012 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 24 | Day |
Last modified on
| 2013 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008382
