UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011880
Receipt number 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 05:40:32

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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 or person

Institute

Department of Orthopaedic Surgery,
Juntendo University, Faculty of Medicine

Institute

Department

Personal name



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

Value
https://center6.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