UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018421
Receipt number R000021293
Scientific Title Intra-rater reliability of the ultrasonography for measuring a femoral head translation during the hip joint-instability tests
Date of disclosure of the study information 2015/07/30
Last modified on 2016/02/09 20:49:37

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Basic information

Public title

Intra-rater reliability of the ultrasonography for measuring a femoral head translation during the hip joint-instability tests

Acronym

Intra-rater reliability of the ultrasonography for measuring a femoral head translation during the hip joint-instability tests.

Scientific Title

Intra-rater reliability of the ultrasonography for measuring a femoral head translation during the hip joint-instability tests

Scientific Title:Acronym

Intra-rater reliability of the ultrasonography for measuring a femoral head translation during the hip joint-instability tests.

Region

Japan


Condition

Condition

Hip joints of health adult male

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We measure the femoral head translation amout at the time of hip joint-instability tests(passive hip joint extension,Log Roll test and FABER test) by ultrasonography and reveal its intra-rater reliability.

Basic objectives2

Others

Basic objectives -Others

To reveal intra-rater reliability of the femoral head translation amount,we examin Bland-Altman method to investigate presence or absence of systematic errors,then,we calculate intraclass correlation coefficients,standard error of measurement and minimal detectable change.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Femoral head translation amount

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Examiner perform the hip joint-instability tests(passive hip exstension,Logroll test and FABER test) during ultrasonograhy that view the longitudinal anterior hip joint.

Interventions/Control_2


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

1)Healthy adult male
2)Without history in the hip joint
3)without hip pain in the present
4)Not receiving medical care by hip disorders
5)Consent for participation in this study have been obtained by the document

Key exclusion criteria

1)Regardless of the presence or absence of medical institutions visit, hip pain within the past three months occurs and the pain had continued for more than a week
2)The doctor determin that improper

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yamaji Takehiko

Organization

Graduate school of Gunma university

Division name

Faculty of health sciences

Zip code


Address

3-39-22,Shouwa-machi,Maebashi-shi,Gunma

TEL

027-220-8948

Email

tyamaji@gunma-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Watanabe Hideomi

Organization

Graduate school of Gunma university

Division name

Faculty of health sciences

Zip code


Address

3-39-22,Shouwa-machi,Maebashi-shi,Gunma

TEL

027-220-8945

Homepage URL


Email

watanabeh@gunma-u.ac.jp


Sponsor or person

Institute

Faculty of health sciences at the graduate school of Gunma university

Institute

Department

Personal name



Funding Source

Organization

Faculty of health sciences at the graduate school of Gunma 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


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

2015 Year 07 Month 30 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

2015 Year 07 Month 22 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2015 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 07 Month 25 Day

Last modified on

2016 Year 02 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021293


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name