UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002184 |
|---|---|
| Receipt number | R000002550 |
| Scientific Title | Evaluation static range of movement of the elbow: comparative study between visual estimate, goniometry, fleximetry, biophotogrammetry and radiological goniometry |
| Date of disclosure of the study information | 2009/07/11 |
| Last modified on | 2009/07/11 03:38:13 |
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Basic information
Public title
Evaluation static range of movement of the elbow: comparative study between visual estimate, goniometry, fleximetry, biophotogrammetry and radiological goniometry
Acronym
Evaluation static range of movement of the elbow
Scientific Title
Evaluation static range of movement of the elbow: comparative study between visual estimate, goniometry, fleximetry, biophotogrammetry and radiological goniometry
Scientific Title:Acronym
Evaluation static range of movement of the elbow
Region
| South America |
Condition
Condition
Healthy subjects
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the reliability level intra and interrater of ROM evaluation done by visual estimate;
Evaluate the reliability level intra and interrater of ROM evaluation done by goniometry;
Evaluate the reliability level intra and interrater of ROM evaluation done by fleximetry;
Evaluate the reliability level intra and interrater of ROM evaluation done by biophotogrametry.
Basic objectives2
Others
Basic objectives -Others
Evaluate the correlation level between visual estimate, goniometry, fleximetry, biophotogrammetry with radiological goniometry.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
A ample variation of results was gotten with the technique of visual estimate, demonstrating a heterogeneous distruição of the data.
The others techniques had presented homogeneous distribution of the data.
Key secondary outcomes
The investigated techniques had presented several levels of reliability.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
5
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Evaluation static range of movement of the elbow by visual estimate.
Interventions/Control_2
Evaluation static range of movement of the elbow by goniometry.
Interventions/Control_3
Evaluation static range of movement of the elbow by fleximetry.
Interventions/Control_4
Evaluation static range of movement of the elbow by biophotogrametry.
Interventions/Control_5
Evaluation static range of movement of the elbow by radiological goniometry.
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 19 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Male aged between 19-25 years.
2. Witohut orthopedic and neurologic history pathologies and or that interfere in mobility and right superior member bones normal anatomy.
3. In the last 12 months the subjects did not make a radiography exam.
Key exclusion criteria
1. Not to take care of to the inclusion criteria.
2. To present allergic reaction to the radiation.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rodrigo Luis Ferreira da Silva |
Organization
Para State University / Castelo Branco Univesity
Division name
Human Movement Science Department / Bioscience of the Human Motility Laboratory
Zip code
Address
Placido de Castro avenue, 1399 / Salvador Allende avenue, 6700
TEL
+81-0-55-93-35235118
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rodrigo Luis Ferreira da Silva |
Organization
Para State University
Division name
Human Movement Science Department
Zip code
Address
Placido de Castro avenue, 1399
TEL
+81-0-55-93-35235118
Homepage URL
rodrigolfs@yahoo.com.br
Sponsor or person
Institute
Para State University
Institute
Department
Personal name
Funding Source
Organization
Researchers
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Brazil
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
| 2009 | Year | 07 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2008 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 11 | Day |
Last modified on
| 2009 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002550
