UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033208
Receipt number R000037864
Scientific Title Effect of knee varus instability-reducing shoes on gait parameters, knee pain and health-related quality of life in patients with medial knee osteoarthritis
Date of disclosure of the study information 2018/06/30
Last modified on 2018/06/30 08:09:48

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Basic information

Public title

Effect of knee varus instability-reducing shoes on gait parameters, knee pain and health-related quality of life in patients with medial knee osteoarthritis

Acronym

Effect of knee varus instability-reducing shoes on gait parameters, knee pain and health-related quality of life in patients with medial knee osteoarthritis

Scientific Title

Effect of knee varus instability-reducing shoes on gait parameters, knee pain and health-related quality of life in patients with medial knee osteoarthritis

Scientific Title:Acronym

Effect of knee varus instability-reducing shoes on gait parameters, knee pain and health-related quality of life in patients with medial knee osteoarthritis

Region

Japan


Condition

Condition

Knee osteoarthritis

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of knee varus instability-reducing shoes on gait parameters, knee pain and health-related quality of life in patients with medial knee osteoarthritis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Gait parameters, knee pain and Japanese Knee Osteoarthritis Measure

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Knee varus instability-reducing shoes

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

80 years-old >=

Gender

Female

Key inclusion criteria

Patients with knee osteoarthritis

Key exclusion criteria

Patients with Mini-Mental State Examination (MMSE) scores below 24, neurological, or psychiatric diseases that might influence the results, or inability to walk independently

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shin Murata

Organization

Kyoto Tachibana University

Division name

Faculty of Health Science

Zip code


Address

34 Yamada-cho, Oyake, Yamashina-ku, Kyoto-city, Kyoto

TEL

+81-75-571-1111

Email

murata-s@tachibana-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideki Nakano

Organization

Kyoto Tachibana University

Division name

Faculty of Health Science

Zip code


Address

34 Yamada-cho, Oyake, Yamashina-ku, Kyoto-city, Kyoto

TEL

+81-75-571-1111

Homepage URL


Email

nakano-h@tachibana-u.ac.jp


Sponsor or person

Institute

Kyoto Tachibana University

Institute

Department

Personal name



Funding Source

Organization

Kyoto Tachibana 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

2018 Year 06 Month 30 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

2017 Year 06 Month 19 Day

Date of IRB


Anticipated trial start date

2017 Year 06 Month 19 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 06 Month 30 Day

Last modified on

2018 Year 06 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037864


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name