UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029392
Receipt number R000032001
Scientific Title The effect of high velocity trunk exercise on gait ability of patients after total hip arthroplasty
Date of disclosure of the study information 2017/10/02
Last modified on 2020/10/29 08:16:14

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Basic information

Public title

The effect of high velocity trunk exercise on gait ability of patients after total hip arthroplasty

Acronym

The effect of high velocity trunk exercise on gait ability of patients after total hip arthroplasty

Scientific Title

The effect of high velocity trunk exercise on gait ability of patients after total hip arthroplasty

Scientific Title:Acronym

The effect of high velocity trunk exercise on gait ability of patients after total hip arthroplasty

Region

Japan


Condition

Condition

Hip osteoarthritis.

Classification by specialty

Orthopedics 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 THA patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Walking speed of 7 days, 12days, 14 days, 18 days, 52 days, 84 days after surgery.

Key secondary outcomes

Stride time and Coefficient of variability, Timed up & go test, hip and knee isometric muscle strength, Trunk extension endurance, Short physical performance battery, Harris hip score, Passive range of motion.


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who had total hip arthroplasty.
Patients who can walk a cane of 10 m or more at preoperative and one week after surgery.

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

60


Research contact person

Name of lead principal investigator

1st name Keisuke
Middle name
Last name Honma

Organization

Tominaga hospital

Division name

Department of Rehabilitation

Zip code

556-0017

Address

1-4-48, Minatomachi, Naniwa-ku, Osaka city, Osaka prefecture, Japan.

TEL

06-6568-1601

Email

minichan07@hotmail.co.jp


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

583-8555

Address

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

TEL

072-950-2111

Homepage URL


Email

minichan07@hotmail.co.jp


Sponsor or person

Institute

Tominaga hospital

Institute

Department

Personal name



Funding Source

Organization

Not exist

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

Tominaga hospital

Address

1-4-48, Minatomachi, Naniwa-ku, Osaka city, Osaka prefecture, Japan.

Tel

06-6568-1601

Email

minichan07@hotmail.co.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

富永病院(大阪府)


Other administrative information

Date of disclosure of the study information

2017 Year 10 Month 02 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

2017 Year 07 Month 01 Day

Date of IRB

2017 Year 07 Month 04 Day

Anticipated trial start date

2017 Year 07 Month 07 Day

Last follow-up date

2018 Year 09 Month 24 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 10 Month 02 Day

Last modified on

2020 Year 10 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032001


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name