UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The foot part intrinsic muscle has ability in support of the foot medial longitudinal arch at the walk
Title of the study (Brief title)	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	shusaku kanai
Organization	Prefectural University of Hiroshima
Division name	Faculty of Health and welfare
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	shusaku kanai
Organization	Prefectural University of Hiroshima
Division name	Faculty of Health and welfare
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://doi.org/10.1016/j.foot.2017.08.002
Results
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