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
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
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
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
