UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009095
Receipt number R000010661
Scientific Title Effectiveness of therapeutic exercises or a shoe lift for functional leg length discrepancy after total hip arthroplasty
Date of disclosure of the study information 2012/10/12
Last modified on 2017/11/27 17:48:15

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Basic information

Public title

Effectiveness of therapeutic exercises or a shoe lift for functional leg length discrepancy after total hip arthroplasty

Acronym

Intervention study for functional leg length discrepancy after THA

Scientific Title

Effectiveness of therapeutic exercises or a shoe lift for functional leg length discrepancy after total hip arthroplasty

Scientific Title:Acronym

Intervention study for functional leg length discrepancy after THA

Region

Japan


Condition

Condition

total hip arthroplasty

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To study the effectiveness of therapeutic exercises or a shoe lift in improving functional and perceived leg length discrepancy and functional outcomes in patients after THA.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Functional and perceived leg length discrepancy

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

therapeutic exercise 2 weeks

Interventions/Control_2

shoe lift 2 weeks

Interventions/Control_3

a standard rehabilitation

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

20 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

inpatients after elective THA
unilateral and primary arthroplasty
functional leg length discrepancy more than 5 mm
having patient-perceived leg length discrepancy
weight less than 100 kg
ASA up to 3
possible communication
consent of patient

Key exclusion criteria

anamnesis of central or peripheral disorder
operation time more than 3 hours
osteotomy
grafted bone
serious complication
inappropriate by their doctor&#39;s judgement

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichi Izumi

Organization

Tohoku University graduate school of biomedical engineering

Division name

Physical medicine and Rehabilitation

Zip code


Address

2-1 Seiryo-machi, Aobaku, Sendai

TEL

022-717-7338

Email

t-nakanowatari@med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuya Nakanowatari

Organization

Yamagata Prefectural Univercity of Health Sciences

Division name

Physical Therapy

Zip code


Address

260 Kamiyanagi, Yamagata city, Yamagata

TEL

023-686-6665

Homepage URL


Email

t-nakanowatari@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University graduate school of medicine

Institute

Department

Personal name



Funding Source

Organization

administrative cost of department

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

松田病院(宮城県)


Other administrative information

Date of disclosure of the study information

2012 Year 10 Month 12 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.physiotherapyjournal.com/issue/S0031-9406(15)X0004-6?page=27

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 10 Month 30 Day

Date of IRB


Anticipated trial start date

2013 Year 02 Month 01 Day

Last follow-up date

2014 Year 02 Month 28 Day

Date of closure to data entry

2014 Year 04 Month 30 Day

Date trial data considered complete

2014 Year 06 Month 30 Day

Date analysis concluded

2016 Year 11 Month 09 Day


Other

Other related information



Management information

Registered date

2012 Year 10 Month 11 Day

Last modified on

2017 Year 11 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010661


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name