UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012615
Receipt number R000014752
Scientific Title Relationship between hip joint muscle strength or muscle activity ratio and knee joint mechanical stress during walking in patients with knee osteoarthritis
Date of disclosure of the study information 2013/12/18
Last modified on 2016/12/20 23:31:45

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Basic information

Public title

Relationship between hip joint muscle strength or muscle activity ratio and knee joint mechanical stress during walking in patients with knee osteoarthritis

Acronym

Relationship between hip joint function and knee joint mechanical stress during walking in patients with knee osteoarthritis

Scientific Title

Relationship between hip joint muscle strength or muscle activity ratio and knee joint mechanical stress during walking in patients with knee osteoarthritis

Scientific Title:Acronym

Relationship between hip joint function and knee joint mechanical stress during walking in patients with knee osteoarthritis

Region

Japan


Condition

Condition

Knee osteoarthritis

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate relationship between hip joint function and knee joint mechanical stress during walking in patients with knee osteoarthritis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

Mechanical stress of knee joint during walking by Accelerater

Key secondary outcomes

The hip musculature strength ratio and Muscle activity ratio, knee Pain during walking, hip and knee Range of motion


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. kellgren and Lawrence grade 2-4
2. can walk unassisted more than 16m
3. with knee pain during walking

Key exclusion criteria

1. History of severe orthopedic disease excluding knee osteoarthritis, other neurological disorders

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroaki Yamano

Organization

Kio University

Division name

Graduate School of Health Science

Zip code


Address

4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN

TEL

+81-745-54-1601

Email

Kio.pt.baseballer@mbr.nifty.com


Public contact

Name of contact person

1st name
Middle name
Last name Hiroaki Yamano

Organization

Kio University

Division name

Graduate School of Health Science

Zip code


Address

4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN

TEL

+81-745-54-1601

Homepage URL


Email

Kio.pt.baseballer@mbr.nifty.com


Sponsor or person

Institute

Kio University

Institute

Department

Personal name



Funding Source

Organization

Kio University

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor

Koyama clinic

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

畿央大学(奈良県)


Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 18 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

2013 Year 12 Month 31 Day

Date of IRB


Anticipated trial start date

2014 Year 01 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

relationship between hip joint function and knee joint mechanical stress during walking in patients with knee osteoarthritis


Management information

Registered date

2013 Year 12 Month 18 Day

Last modified on

2016 Year 12 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014752


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name