- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01843816
The Effect of Body Shape on Tragus-Wall Measurement
September 30, 2013 updated by: Nihal Ozaras, Vakif Gureba Training and Research Hospital
Tragus-to-wall distance (TWD) measurements is a method to evaluate spinal mobility in ankylosing spondylitis (AS) patients and it also takes place in Bath Ankylosing Spondylitis Metrology Index (BASMI).
Being obese or slim may affect TWD.
As well as the person's losing or taking weight may lead wrong evaluations, in comparative studies, according to the height or weight uneven distribution of groups may affect the results.
The aim of this study is to investigate whether the body shape affect TWD or not.
Study Overview
Status
Completed
Conditions
Detailed Description
Healthy volunteers between 18-65 ages who have no disorder that may disturb posture or erect position (inflammatory diseases, kyphosis, scoliosis, joint deformities)will be included into the study.
A wall corner will be used as the measurement platform; the evaluated person will be positioned as described in BASMI.
A rigid ruler will be placed form anterior superior iliac spine (SIAS) to the lateral wall, parallel to the back wall; a projection point will be determined and its distance from back wall will be measured (SIAS-WD).
In the same position, projection point of the middle of the humerus head and back wall distance (shoulder-WD) and TWD also will be measured.
The relationships between these parameters will be statistically assessed.
Study Type
Observational
Enrollment (Actual)
465
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Istanbul, Turkey, 34093
- Bezmialem Vakif University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
healthy subjects between 18-65 ages who have no disorder that may disturb posture or erect position (inflammatory diseases, kyphosis, scoliosis, joint deformities)
Description
Inclusion Criteria:
- Volunteers between 18-65 ages
Exclusion Criteria:
- subjects with disorders that may disturb posture or erect position
- inflammatory diseases,
- kyphosis,
- scoliosis,
- joint deformities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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healthy subjects
18-65 aged healthy subjects who have no disorder that may disturb posture or erect position (inflammatory diseases, kyphosis, scoliosis, joint deformities)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The assessment of the effects of having different weight and body shape on Tragus-Wall Measurement
Time Frame: 15 months
|
Volunteers between 18-65 ages who have no disorder that may disturb posture or erect position (inflammatory diseases, kyphosis, scoliosis, joint deformities) will be included into the study.Their height, weight, hip circumference and tragus-to-wall distance will be measured.
The relationship between these measurements will be calculated
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15 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Nihal Ozaras, Ass.Prof., Bezmialem Vakif University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
April 22, 2013
First Submitted That Met QC Criteria
April 26, 2013
First Posted (Estimate)
May 1, 2013
Study Record Updates
Last Update Posted (Estimate)
October 1, 2013
Last Update Submitted That Met QC Criteria
September 30, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- tragus-wall
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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