UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039544
Receipt number R000045092
Scientific Title The relationship between sit-to-stand and walking, and stiffness of knee joint among patients with knee osteoarthritis
Date of disclosure of the study information 2020/03/09
Last modified on 2022/08/01 10:17:35

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Basic information

Public title

The relationship between standing up and walking, and stiffness of knee joint among patients with knee osteoarthritis

Acronym

The relationship between movement and stiffness of knee joint among patients with knee osteoarthritis

Scientific Title

The relationship between sit-to-stand and walking, and stiffness of knee joint among patients with knee osteoarthritis

Scientific Title:Acronym

The relationship between movement and stiffness of knee joint among 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 identify the relationship between sit-to-stand and walking, and stiffness of knee joint among patients with knee osteoarthritis

Basic objectives2

Others

Basic objectives -Others

kinematic and kinetic analysis

Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

stiffness of knee joint

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

45 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

OA group
If a person
-has activity-related knee joint pain
-has either no morning joint-related stiffness or morning stiffness that lasts no longer than 30minutes.
Control group
If a person
-has no pain and dysfunction of the knee
-has no surgical history in lower extremities
-has no neurological deficit of lower extremities

Key exclusion criteria

If a person
-has surgical history in lower extremities
-has neurological deficit of lower extremities
-has pain and dysfunction except knee OA disturbing lower extremities' movement

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Daisuke
Middle name
Last name Uritani

Organization

Kio University

Division name

Department of Physical Therapy

Zip code

6350832

Address

4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara

TEL

0745541601

Email

d.uritani@kio.ac.jp


Public contact

Name of contact person

1st name Hiroshi
Middle name
Last name Nakayama

Organization

Kio University

Division name

Department of Administration

Zip code

6350832

Address

4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara

TEL

0745541601

Homepage URL


Email

soumu@kio.ac.jp


Sponsor or person

Institute

Kio University

Institute

Department

Personal name



Funding Source

Organization

Kio 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

Kio University

Address

4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara

Tel

0745541601

Email

soumu@kio.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

201911001

Org. issuing International ID_1

Kashiba Asahigaoka Hospital

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 03 Month 09 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

Terminated

Date of protocol fixation

2020 Year 02 Month 20 Day

Date of IRB

2020 Year 03 Month 10 Day

Anticipated trial start date

2020 Year 03 Month 10 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Cross-sectional study


Management information

Registered date

2020 Year 02 Month 20 Day

Last modified on

2022 Year 08 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045092


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name