UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019127 |
|---|---|
| Receipt number | R000022111 |
| Scientific Title | The influence of adopting insole insertion for flatfoot against body function and subjective symptoms |
| Date of disclosure of the study information | 2015/09/27 |
| Last modified on | 2016/05/22 16:33:43 |
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Basic information
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
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
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
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
| 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
shimomai@luke.ac.jp
Public contact
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
shimomai@luke.ac.jp
Sponsor or person
Institute
St.Lukes international hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022111
