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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023113
Receipt No. R000026480
Scientific Title The foot part intrinsic muscle has ability in support of the foot medial longitudinal arch at the walk
Date of disclosure of the study information 2016/07/11
Last modified on 2019/01/11

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Basic information
Public title The foot part intrinsic muscle has ability in support of the foot medial longitudinal arch at the walk
Acronym An effect of the increasing at intrinsic muscles of foot for foot arch
Scientific Title The foot part intrinsic muscle has ability in support of the foot medial longitudinal arch at the walk
Scientific Title:Acronym An effect of the increasing at intrinsic muscles of foot for foot arch
Region
Japan

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

Objectives
Narrative objectives1 Effect of the electrical stimulation on intrinsic foot muscles during gait to make changes supporting the MLA under a dynamic condition.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes joint moment
foot arch 3D motion
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 electrical stimulation to intrinsic foot muscles
5 minutes
below pain threshold
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
40 years-old >
Gender Male and Female
Key inclusion criteria healthy adults
Key exclusion criteria orthopedics disease in the past now
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name shusaku kanai
Organization Prefectural University of Hiroshima
Division name Faculty of Health and welfare
Zip code
Address 1-1 Gakuen Machi, Mihara City, Hiroshima-Ken
TEL 0848-60-1120
Email kanai@pu-hiroshima.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name shusaku kanai
Organization Prefectural University of Hiroshima
Division name Faculty of Health and welfare
Zip code
Address 1-1 Gakuen Machi, Mihara City, Hiroshima-Ken
TEL 0848-60-1120
Homepage URL
Email kanai@pu-hiroshima.ac.jp

Sponsor
Institute Prefectural University of Hiroshima
Institute
Department

Funding Source
Organization Prefectural University of Hiroshima
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1016/j.foot.2017.08.002
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
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2018 Year 03 Month 24 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 04 Month 30 Day
Date analysis concluded
2018 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 07 Month 11 Day
Last modified on
2019 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026480

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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