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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013298
Receipt No. R000015497
Scientific Title Effects of shoes and insoles has on the mechanical stress of the knee joint
Date of disclosure of the study information 2014/02/28
Last modified on 2016/03/03

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Basic information
Public title Effects of shoes and insoles has on the mechanical stress of the knee joint
Acronym Effects of shoes and insoles has on the mechanical stress of the knee joint
Scientific Title Effects of shoes and insoles has on the mechanical stress of the knee joint
Scientific Title:Acronym Effects of shoes and insoles has on the mechanical stress of the knee joint
Region
Japan

Condition
Condition Osteoarthritis of the knee
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verification of the effect insoles and shoes
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Lower extremity joint moments
Lower limb EMG
Foot pressure center trajectory
Knee joint outside acceleration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 7
Purpose of intervention Prevention
Type of intervention
Device,equipment Other
Interventions/Control_1 barefoot
Interventions/Control_2 lateral wedged insoles
Interventions/Control_3 medial wedged insoles
Interventions/Control_4 insoles of the hindfoot
Interventions/Control_5 insoles of the forefoot
Interventions/Control_6 shoes adapted size
Interventions/Control_7 shoes size incompatibility
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria A person walking 10m is possible
Key exclusion criteria A person who has a neurological disease and musculoskeletal disease marked in osteoarthritis of the knee other than
Those who can not consent and who can not understand the description of the present study
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Tanaka
Organization Kio University Graduate School
Division name Health Sciences
Zip code
Address Nara Katsuragi gun Koryo-cho 4-2-2 Umaminaka
TEL 0745-54-1602
Email zipputanaka@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Tanaka
Organization Kio University Graduate School
Division name Health Sciences
Zip code
Address Nara Katsuragi gun Koryo-cho 4-2-2 Umaminaka
TEL 0745-54-1602
Homepage URL
Email zipputanaka@gmail.com

Sponsor
Institute Kio University Graduate School of Health Sciences
Institute
Department

Funding Source
Organization Kio University Graduate School of Health Sciences
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
2014 Year 02 Month 28 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
2014 Year 02 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 27 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
2014 Year 02 Month 28 Day
Last modified on
2016 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015497

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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