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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032329
Receipt No. R000036642
Scientific Title The characteristic of arch height and influence of dynamic balance by intervention of exercise in flatfoot.
Date of disclosure of the study information 2018/04/30
Last modified on 2019/02/15

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Basic information
Public title The characteristic of arch height and influence of dynamic balance by intervention of exercise in flatfoot.
Acronym The characteristic of arch height and influence by intervention of exercise in flatfoot.
Scientific Title The characteristic of arch height and influence of dynamic balance by intervention of exercise in flatfoot.
Scientific Title:Acronym The characteristic of arch height and influence by intervention of exercise in flatfoot.
Region
Japan

Condition
Condition flatfoot
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. The investigation of characteristic of arch height in ages and habit of exercise.
2. The investigation of persistent effect after the intervention by short foot exercise.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1.Questionnaire:name,gender,age,dominant side,history of exercise,medical history
2.Height
3.Weight
4.Foot shape
5.Center of pressure in testing Y-Balance Test(Before intervention and after four weeks)
Key secondary outcomes None

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Measurement periods set of this research are 3 times, and is total of 6 weeks. Short foot exercise is guided in the 1st time of measurement for classified flat foot group. Short foot exercise is the movement that the contraction of foot intrinsic muscle which shortens foot assembly. The movement maintain for 10 seconds, take a rest for 5 seconds and repeat in 30 minutes. Doing this exercise 3 times a week until the 2nd time of measurement for 4 weeks. The 3rd time will be measured 2 weeks later. Make sure that flat foot group won't do Short foot exercise after the 2nd time of measurement until the 3rd time of measurement.
Interventions/Control_2 Measurement periods set of this research are 3 times, and is total of 6 weeks. No intervention is guided in the 1st time of measurement for control group.The 2nd time of measurement will be measured 4 weeks later.The 3rd time will be measured 2 weeks later of The 2nd time of measurement.
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
30 years-old >=
Gender Male and Female
Key inclusion criteria 1.Can stand independently.
2.No history of fructure in lower extremity.
3.No sport training in lower extremity.
4.No systemic disease.
Key exclusion criteria When the person in charge or the object judges that couldn't continue the measurment, the measurment is stopped immediately.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name KUO SHU HAN
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
Address 2-579-15 Mikajima Tokorozawa Saitama 359-1192 Japan
TEL 070-2178-3657
Email shokan0714@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name KUO SHU HAN
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
Address 2-579-15 Mikajima Tokorozawa Saitama 359-1192 Japan
TEL 070-2178-3657
Homepage URL
Email shokan0714@hotmail.com

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization none
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
2018 Year 04 Month 30 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 The relationship between arch height index and age is increasing before age of 40, and starts to decline from age of 40, and the relationship between arch height index and BMI is declined in excess weight.
The arch height index in male was higher than in females.
The trail of COP in the ML direction of flatfoot was narrower than that of neutral foot.The intervention of SFE for four weeks could effectively improve the arch height and maintain the height for at least three weeks.
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
2018 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 30 Day
Last follow-up date
2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 20 Day
Last modified on
2019 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036642

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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