UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027909
Receipt number R000031923
Scientific Title An Easy and Safe Training Method for Trunk Function Improves Mobility in Total Knee Arthroplasty Patients
Date of disclosure of the study information 2017/06/25
Last modified on 2017/06/23 22:35:24

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Basic information

Public title

An Easy and Safe Training Method for Trunk Function Improves Mobility in Total Knee Arthroplasty Patients

Acronym

An Easy Training for Trunk Function Improves Mobility in TKA patients

Scientific Title

An Easy and Safe Training Method for Trunk Function Improves Mobility in Total Knee Arthroplasty Patients

Scientific Title:Acronym

An Easy Training for Trunk Function Improves Mobility in TKA patients

Region

Japan


Condition

Condition

knee osteoarthritis

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to address the effectiveness of Seated Side Tapping (SST) training, which focuses on the quickness of trunk movement in a seated position, on mobility in TKA patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Gait speed

Key secondary outcomes

TUG, Knee function


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

At 2 days after surgery, patients in the SST group carried out SST training in addition to the standard inpatient rehabilitation program. The total time of one set of SST training including preparation was 3 minutes per day.

Interventions/Control_2

The standard inpatient rehabilitation program.

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

Patients who had total knee arthroplasty

The ability to walk 10 m or more without assistance one week after TKA.

Key exclusion criteria

A participant was excluded if patients had any medical or neurological problem that would affect their ability to complete this trial, such as severe dementia, stroke, cardiac insufficiency, or acute respiratory failure.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuki Sano

Organization

Osaka General Medical Center

Division name

Department of Rehabilitation

Zip code


Address

3-1-56 Bandaihigashi, Sumiyoshi-ku, Osaka, Japan

TEL

06-6692-1201

Email

yuukick1124@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Iwata Akira

Organization

Osaka Prefecture University

Division name

Graduate School of Comprehensive Rehabilitation

Zip code


Address

3-7-30 Habikino, Habikino city, Osaka prefecture, Japan

TEL

072-950-2111

Homepage URL


Email

iwata@rehab.osakafu-u.ac.jp


Sponsor or person

Institute

Osaka General Medical Center

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2017 Year 06 Month 25 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

2012 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 05 Month 01 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

2017 Year 06 Month 23 Day

Last modified on

2017 Year 06 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031923


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name