UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041878
Receipt number R000047660
Scientific Title Physical Factors Affecting the Difficulty of Descending Stairs in Patients After Total Knee Arthroplasty
Date of disclosure of the study information 2020/09/28
Last modified on 2020/09/24 08:39:19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Physical Factors Affecting the Difficulty of Descending Stairs in Patients After Total Knee Arthroplasty

Acronym

Physical Factors Affecting the Difficulty of Descending Stairs in Patients After Total Knee Arthroplasty

Scientific Title

Physical Factors Affecting the Difficulty of Descending Stairs in Patients After Total Knee Arthroplasty

Scientific Title:Acronym

Physical Factors Affecting the Difficulty of Descending Stairs in Patients After Total Knee Arthroplasty

Region

Japan


Condition

Condition

total knee replacement surgery

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To identify the physical factors required for stair-descent in patients after total knee arthroplasty.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Descending stairs at 3 months after surgery

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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Inclusion criteria are patients who were diagnosed as medial knee osteoarthritis, were 3 months after total knee replacement, and were able to ascend and descend stairs with stand by assist .

Key exclusion criteria

Exclusion criteria are patients with orthopedic or neurological disorders that interfere with stair climbing and patient underwent total knee replacement on the opposite side within one year of the procedure.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name takayuki
Middle name
Last name murakami

Organization

Shimada hospital

Division name

department of rehabilitation

Zip code

5830875

Address

100-1 Kashiyama, Habikino City, Osaka Prefecture

TEL

0729531001

Email

t.muucho.0518@gmail.com


Public contact

Name of contact person

1st name takayuki
Middle name
Last name murakami

Organization

Shimada hospital

Division name

department of rehabilitation

Zip code

5830875

Address

100-1 Kashiyama, Habikino City, Osaka Prefecture

TEL

0729531001

Homepage URL


Email

t.muucho.0518@gmail.com


Sponsor or person

Institute

department of rehabilitation, Shimada hospital

Institute

Department

Personal name



Funding Source

Organization

self-funding

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Physical Therapy, Faculty of Comprehensive Rehabilitation, Osaka Prefecture University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shimada hospital

Address

100-1 Kashiyama, Habikino City, Osaka Prefecture

Tel

0729531001

Email

t.muucho.0518@gmail.com


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

2020 Year 09 Month 28 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

79

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

2018 Year 06 Month 10 Day

Date of IRB

2018 Year 06 Month 24 Day

Anticipated trial start date

2018 Year 07 Month 12 Day

Last follow-up date

2019 Year 10 Month 04 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Participants are patients who underwent total knee arthroplasty at our hospital and could be measured by the same examiner in our outpatient setting 3 months after surgery.


Management information

Registered date

2020 Year 09 Month 24 Day

Last modified on

2020 Year 09 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047660


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name