UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030073
Receipt number R000034299
Scientific Title A study on a new rehabilitation program after total hip arthroplasty
Date of disclosure of the study information 2017/12/01
Last modified on 2017/11/22 08:24:49

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Basic information

Public title

A study on a new rehabilitation program after total hip arthroplasty

Acronym

Effect of early rehabilitation on total hip arthroplasty

Scientific Title

A study on a new rehabilitation program after total hip arthroplasty

Scientific Title:Acronym

Effect of early rehabilitation on total hip arthroplasty

Region

Japan


Condition

Condition

Patients after total hip arthroplasty

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine the effect on outcome by rehabilitation program which starts rehabilitation immediately after surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Gait analysis

Key secondary outcomes

Range of motion, muscle strength, pain, quality of life


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Rehabilitation (joint movement exercise, muscle strength exercise) is started within the possible range within 6 hours after total hip arthroplasty.

Interventions/Control_2

As usual, rehabilitation starts from the 2nd postoperative day.

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

30 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

Patient who undergoes primary total hip arthroplasty by hip osteoarthritis or femoral head necrosis.

Key exclusion criteria

Cases with motor and sensory disorders due to central nervous disorders, patients with mental illness, patients with dementia.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideaki Matsuo

Organization

University of Fukui hospital

Division name

Division of Physical Therapy and Rehabilitation Medicine

Zip code


Address

23-3, Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui

TEL

0776-61-8676

Email

hideakim@u-fukui.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideaki Matsuo

Organization

University of Fukui Hospital

Division name

Division of Physical Therapy and Rehabilitation Medicine

Zip code


Address

23-3, Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui

TEL

0776-61-8676

Homepage URL


Email

hideakim@u-fukui.ac.jp


Sponsor or person

Institute

University of Fukui

Institute

Department

Personal name



Funding Source

Organization

University of Fukui

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 12 Month 01 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

Preinitiation

Date of protocol fixation

2017 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 04 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 11 Month 22 Day

Last modified on

2017 Year 11 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034299


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name