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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002184
Receipt No. 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

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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
Email

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
Email rodrigolfs@yahoo.com.br

Sponsor
Institute Para State University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002550

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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