UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021794
Receipt number R000025135
Scientific Title Improvement of functional activity and determinants of discharge delay in patients after Total knee arthroplasty
Date of disclosure of the study information 2016/04/07
Last modified on 2016/10/07 09:48:42

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Basic information

Public title

Improvement of functional activity and determinants of discharge delay in patients after Total knee arthroplasty

Acronym

Improvement of functional activity and determinants of discharge delay in patients after Total knee arthroplasty

Scientific Title

Improvement of functional activity and determinants of discharge delay in patients after Total knee arthroplasty

Scientific Title:Acronym

Improvement of functional activity and determinants of discharge delay in patients after Total knee arthroplasty

Region

Japan


Condition

Condition

Total knee arthroplasty

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of improvement of functional activity and determinants of discharge delay in patients after total knee arthroplasty surgery during inpatient rehabilitation.

Basic objectives2

Others

Basic objectives -Others

The purpose of improvement of pain and determinants of discharge delay in patients after total knee arthroplasty surgery during inpatient rehabilitation.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visual Analog Scale

Key secondary outcomes

Maximum voluntary isometric knee extension force, Timed Up and Go test, 2 minites walk test,Pain Catastrophizing Scale


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

traditional exercise(40-60 minutes per day, 6 days a week, for 4 weeks)

Interventions/Control_2

traditional exercise(40-60 minutes per day, 6 days a week, for 4 weeks)

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

underwent a primary unilateral Total knee arthroplasty.

Key exclusion criteria

bone and joint desease, neurological disorders with motor paralysis, dementia, inability to give informed consent form.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshida Yosuke

Organization

YamatoKashihara Hospital

Division name

Department of Rehabilitation Medicine

Zip code


Address

81, Isikawa-cho, Kashihara-shi, Nara

TEL

0744-27-1071

Email

fortunatefield@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshida Yosuke

Organization

YamatoKashihara Hospital

Division name

Department of Rehabilitation Medicine

Zip code


Address

81, Isikawa-cho, Kashihara-shi, Nara

TEL

0744-27-1071

Homepage URL


Email

fortunatefield@yahoo.co.jp


Sponsor or person

Institute

YamatoKashihara Hospital

Institute

Department

Personal name



Funding Source

Organization

No outside funding was utilized in this trial.

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

2016 Year 04 Month 07 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

Enrolling by invitation

Date of protocol fixation

2015 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 04 Month 01 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 04 Month 06 Day

Last modified on

2016 Year 10 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025135


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name