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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035835
Receipt No. R000040821
Scientific Title The relationship between foot posture, function and knee joint mechanical loading
Date of disclosure of the study information 2019/02/10
Last modified on 2019/02/10

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Basic information
Public title The relationship between foot posture, function and knee joint mechanical loading
Acronym The relationship between foot posture, function and knee joint mechanical loading
Scientific Title The relationship between foot posture, function and knee joint mechanical loading
Scientific Title:Acronym The relationship between foot posture, function and knee joint mechanical loading
Region
Japan

Condition
Condition knee osteoarthritis
healthy adult
Classification by specialty
Orthopedics Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the cross-sectional relationship between foot posture, function and knee joint mechanical loading
Basic objectives2 Others
Basic objectives -Others To assess the cross-sectional relationship of foot posture, function and compartment-specific knee cartilage damage
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Knee joint mechanical loading
Foot posture
Foot function
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient with knee osteoarthritis
Healthy adult
Key exclusion criteria Rheumatoid arthritis
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takanari Kubo
Organization Kio University
Division name Graduate School of Health Science
Zip code
Address 4-2-2 Umami-naka Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL +81-745-54-1601
Email b8987253@kio.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takanari Kubo
Organization Kio University
Division name Graduate School of Health Science
Zip code
Address 4-2-2 Umami-naka Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL +81-745-54-1601
Homepage URL
Email b8987253@kio.ac.jp

Sponsor
Institute Kio University
Institute
Department

Funding Source
Organization Kio 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
2019 Year 02 Month 10 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 03 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will use model of the tibiofemoral joint in OpenSim compute medial and lateral tibiofemoral mechanical loading during walking.

Management information
Registered date
2019 Year 02 Month 10 Day
Last modified on
2019 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040821

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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