UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The influence of adopting insole insertion for flatfoot against body function and subjective symptoms
Title of the study (Brief title)	The influence of adopting insole insertion for flatfoot against body function and subjective symptoms
Region	Japan

Condition
Condition	flat foot
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This is to compare the difference between adopting in-sole to the shoes that nurses at general pharmacy use at daily duties or not,and identify the effect of in-sole to flatfoot,body function and subjective symptoms.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Questionnaire(Weary part check,Numerical Rating Scale,The comfort level of the insole),single leg time(closed eye),hop test
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	The cases which safety the flatfoot diagnosis will be extracted using foot prints when agreement can be obtained by pre-explanation to the floor nurses. Questionnaire,one-footed standing duration measurement and hop test will take place to the target group who are diagnosed as flatfoot before day-to-day operations. In-sole comfort survey as well as similar questionnaire and physical test will take place after daily task. It will take one week duration for wash out without adopting in-sole. Day-to-day operation will take place with in-sole inserted after similar questionnaire and physical test are implemented as second phase trial one week later.In-sole comfort survey as well as similar questionnaire and physical test will take place after daily task. All of in-sole should be same for all target group(2-axis arch pads and heel pads).In order to make this trial blind,existence of in-sole will not be informed to the target group,and base cups,which do not have arch even if it do not come with in-sole,are inserted.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Nurses at general pharmacy,who satisfied the check standard by Informed consent. 2. The person who fills the check standard of flatfoot.
Key exclusion criteria	1.The person who follow-up is difficult or has a request of participation cancellation on the way. 2.The person who has been inserted an insole or treating it already to a flatfoot. 3.That there is no past in one of them of a leg including foot-ankle assemble without flatfoot.
Target sample size	30

Research contact person
Name of lead principal investigator	Mai Shimozuru
Organization	St.Lukes international hospital
Division name	rehabilitation centar
Address	9-1,Akasi-cho,Chuo-ku,Tokyo
TEL	03-5550-7062
Email	shimomai@luke.ac.jp

Public contact
Name of contact person	Mai Shimozuru
Organization	St.Lukes international hospital
Division name	rehabilitation centar
Address	9-1,Akasi-cho,Chuo-ku,Tokyo
TEL	03-5550-7062
Homepage URL
Email	shimomai@luke.ac.jp

Sponsor
Institute	St.Lukes international hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	St.Lukes international hospital
Organization
Division
Category of Funding Organization	Self funding
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	2015 Year 09 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 19 Day
Anticipated trial start date	2015 Year 08 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 27 Day
Last modified on	2016 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022111