UMIN-CTR Clinical Trial

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
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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
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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
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Results Delayed
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Baseline Characteristics
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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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