UMIN-CTR Clinical Trial

Public title

The influence of adopting insole insertion for flatfoot against body function and subjective symptoms

Acronym

The influence of adopting insole insertion for flatfoot against body function and subjective symptoms

Scientific Title

The influence of adopting insole insertion for flatfoot against body function and subjective symptoms

Scientific Title:Acronym

The influence of adopting insole insertion for flatfoot against body function and subjective symptoms

Region

Japan

Condition

flat foot

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Mai Shimozuru

Organization

St.Lukes international hospital

Division name

rehabilitation centar

Zip code

Address

9-1,Akasi-cho,Chuo-ku,Tokyo

TEL

03-5550-7062

Email

shimomai@luke.ac.jp

Name of contact person

1st name
Middle name
Last name	Mai Shimozuru

Organization

St.Lukes international hospital

Division name

rehabilitation centar

Zip code

Address

9-1,Akasi-cho,Chuo-ku,Tokyo

TEL

03-5550-7062

Homepage URL

Email

shimomai@luke.ac.jp

Institute

St.Lukes international hospital

Institute

Department

Personal name

Organization

St.Lukes international hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

09

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

08

Month

19

Day

Date of IRB

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

Other related information

Registered date

2015

Year

09

Month

27

Day

Last modified on

2016

Year

05

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022111