UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040928
Receipt number R000032127
Scientific Title Effect of seated side tapping traning on phase coordination index in patient with total knee arthroplasty
Date of disclosure of the study information 2020/06/28
Last modified on 2021/01/04 16:08:04

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Basic information

Public title

Effect of seated side tapping traning on phase coordination index in patient with total knee arthroplasty

Acronym

Effect of seated side tapping traning on phase coordination index in patient with total knee arthroplasty

Scientific Title

Effect of seated side tapping traning on phase coordination index in patient with total knee arthroplasty

Scientific Title:Acronym

Effect of seated side tapping traning on phase coordination index in patient with total knee arthroplasty

Region

Japan


Condition

Condition

knee osteoarthritis

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate whether seated side tapping training is able to improve phase coordination (PCI) index in patients with TKA.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluate difference of PCI between the intervention group and control group.

Key secondary outcomes

gait speed, 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



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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who had total knee arthroplasty

The ability to walk 30 m or more without assistance before 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 Hideyuki
Middle name
Last name Wanaka

Organization

Osaka General Medical Center

Division name

Department of Rehabilitation

Zip code

558-8558

Address

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

TEL

06-6692-1201

Email

ceh.2o4l.amrmtsc@gmail.com


Public contact

Name of contact person

1st name Akira
Middle name
Last name Iwata

Organization

Osaka Prefecture University

Division name

Graduate School of Comprehensive Rehabilitation

Zip code

599-8531

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

Osaka Prefecture 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

Osaka General Medical Center

Address

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

Tel

06-6692-1201

Email

kyuseisogo@opho.jp


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 06 Month 28 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

100

Results

We found no significant difference in PCI between before (6.73%) and after TKA (6.94%). PCI were significantly correlated with knee extension of the non-operative side and knee pain of the pre-operative side, and knee extension of the non-operative side was selected as independent variable before TKA. However, a significant correlation was found only between PCI and age after TKA.

Results date posted

2020 Year 06 Month 28 Day

Results Delayed

Delay expected

Results Delay Reason

To be published in Journal of the Japanese Physical Therapy Association at a later date.

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 17 Day

Date of IRB

2016 Year 01 Month 04 Day

Anticipated trial start date

2017 Year 06 Month 17 Day

Last follow-up date

2019 Year 06 Month 17 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 06 Month 28 Day

Last modified on

2021 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032127


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name