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

Email



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


Email



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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name