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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036008
Receipt No. R000041013
Scientific Title The effect of insole insertion on the dynamic stability of young healthy subjects
Date of disclosure of the study information 2019/02/25
Last modified on 2019/02/25

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Basic information
Public title The effect of insole insertion on the dynamic stability of young healthy subjects
Acronym The effect of insole insertion on dynamic stability
Scientific Title The effect of insole insertion on the dynamic stability of young healthy subjects
Scientific Title:Acronym The effect of insole insertion on dynamic stability
Region
Japan

Condition
Condition healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the long term effect of plantar insole usage on dynamic stability of young healthy subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes dynamic stability after 1 month or 2 month of insole usage
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 1-month insole usage
Interventions/Control_2 2-months insole usage
Interventions/Control_3 control (no insole usage)
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
24 years-old >=
Gender Male and Female
Key inclusion criteria shoe size between 23cm and 28 cm
experience of regular club sports activity
Key exclusion criteria low dynamic stability fulfilling chronic ankle instability criteria
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryoichi Nagatomi
Organization Tohoku University
Division name Graduate School of Biomedical Engineering
Zip code
Address Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL 022-717-8586
Email nagatomi@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoichi Nagatomi
Organization Tohoku University
Division name Graduate School of Biomedical Engineering
Zip code
Address Seiryo-cho 2-1, Aoba-ku, Sendai, Japan
TEL 022-717-8586
Homepage URL
Email nagatomi@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Biomedical Engineering
Institute
Department

Funding Source
Organization Tohoku University Graduate School of Biomedical Engineering
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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
2019 Year 02 Month 25 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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 21 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 10 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
2019 Year 02 Month 25 Day
Last modified on
2019 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041013

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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