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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026697
Receipt No. R000030651
Scientific Title Effect of insoles with a toe-grip bar on toe function and standing balance in healthy individuals
Date of disclosure of the study information 2017/03/25
Last modified on 2017/03/25

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Basic information
Public title Effect of insoles with a toe-grip bar on toe function and standing balance in healthy individuals
Acronym Insoles with toe-grip bar improve toe function and standing balance
Scientific Title Effect of insoles with a toe-grip bar on toe function and standing balance in healthy individuals
Scientific Title:Acronym Insoles with toe-grip bar improve toe function and standing balance
Region
Japan

Condition
Condition None
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of insoles with a toe-grip bar on toe function and standing balance in healthy individuals.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Toe-grip strength, toe flexibility, total trajectory length, envelop area, and functional reach
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Insoles with toe-grip bar
Interventions/Control_2 Standard insoles
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
19 years-old <=
Age-upper limit
22 years-old >
Gender Female
Key inclusion criteria Healthy women
Key exclusion criteria Orthopedic disease, Neurological disease, Psychiatric disease
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin Murata
Organization Kyoto Tachibana University
Division name Faculty of Health Science
Zip code
Address 34 Yamada-cho, Oyake, Yamashina-ku, Kyoto-city, Kyoto
TEL +81-75-571-1111
Email murata-s@tachibana-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Nakano
Organization Kyoto Tachibana University
Division name Faculty of Health Science
Zip code
Address 34 Yamada-cho, Oyake, Yamashina-ku, Kyoto-city, Kyoto
TEL +81-75-571-1111
Homepage URL
Email nakano-h@tachibana-u.ac.jp

Sponsor
Institute Kyoto Tachibana University
Institute
Department

Funding Source
Organization Kyoto Tachibana University
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
2017 Year 03 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 Completed
Date of protocol fixation
2016 Year 07 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 07 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
2017 Year 03 Month 25 Day
Last modified on
2017 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030651

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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