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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011880
Receipt No. R000013888
Scientific Title Joint motion and gait analysis for patient with locomotive syndrome
Date of disclosure of the study information 2013/10/04
Last modified on 2013/09/27

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Basic information
Public title Joint motion and gait analysis for patient with locomotive syndrome
Acronym Gait analysis for patient with locomotive syndrome
Scientific Title Joint motion and gait analysis for patient with locomotive syndrome
Scientific Title:Acronym Gait analysis for patient with locomotive syndrome
Region
Japan

Condition
Condition Locomotive syndrome, knee osteoarthritis, osteoprosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the relationship between the target diseases and gait and joint motion for the patient.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Ability of gait and range of joint motion
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patient who have been diagnosed with osteoporosis or osteoarthritis of the knee, and the patient without the pain of the knee at the age of 20 or more and the person that was never diagnosed with osteoporosis and knee osteoarthritis.
Key exclusion criteria The following patients are excluded; patients who have received a lower limb surgery, foot or hip osteoarthritis, knee pain due to other disease.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Muneaki Ishijima
Organization Juntendo University Hospital
Division name Orthopaedic Surgery
Zip code
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Email ishijima@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Muneaki Ishijima
Organization Juntendo University Hospital
Division name Orthopaedic Surgery
Zip code
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Homepage URL
Email ishjimap@juntendo.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery,
Juntendo University, Faculty of Medicine
Institute
Department

Funding Source
Organization Department of Orthopaedic Surgery,
Juntendo University, Faculty of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 10 Month 04 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 Open public recruiting
Date of protocol fixation
2013 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 10 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 This study investigates the relationship between the target diseases and the joint motion and gait state. Enforce the stairs and flat walk of 30m with wearable gait measurement system.




Management information
Registered date
2013 Year 09 Month 27 Day
Last modified on
2013 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013888

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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