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CTRI Number  CTRI/2015/06/005930 [Registered on: 19/06/2015] Trial Registered Prospectively
Last Modified On: 18/06/2015
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to find out the differences between Indian and Chinese population in their standing posture 
Scientific Title of Study   Differences in spinal and pelvic postural parameters in two different racial groups, measured using Surface Topography 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arun Mathew Cyriac 
Designation  Research Associate 
Affiliation  Father Muller Medical College Hospital 
Address  Department of Physiotherapy, Fr Muller Medical College Hospital, Kankanady, Mangalore - 575002, Karnataka

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9886638763  
Fax    
Email  arun.mathewpt@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Arun Mathew Cyriac 
Designation  Research Associate 
Affiliation  Father Muller Medical College Hospital 
Address  Department of Physiotherapy, Fr Muller Medical College Hospital, Kankanady, Mangalore - 575002, Karnataka


KARNATAKA
575002
India 
Phone  9886638763  
Fax    
Email  arun.mathewpt@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Arun Mathew Cyriac 
Designation  Research Associate 
Affiliation  Father Muller Medical College Hospital 
Address  Department of Physiotherapy, Fr Muller Medical College Hospital, Kankanady, Mangalore - 575002, Karnataka


KARNATAKA
575002
India 
Phone  9886638763  
Fax    
Email  arun.mathewpt@yahoo.co.in  
 
Source of Monetary or Material Support  
DIERS International GmbH Dillenbergweg 4 D-65388 Schlangenbad, Germany  
 
Primary Sponsor  
Name  Father Muller Research Centre 
Address  Father Muller Medical College, Kankanady, Mangalore - 575002  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Arun Mathew Cyriac  Father Muller Medical College  Spinal and Posture Analysis Lab, Dept of Physiotherapy OPD, Ground Floor, FATHER MULLER MEDICAL COLLEGE HOSPITAL, FATHER MULLER ROAD, KANKANADY, MANGALORE-575002 Dakshina Kannada KARNATAKA
Dakshina Kannada
KARNATAKA 
9886638763

arun.mathewpt@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Asymptomatic, young adults from students of Father Muller Medical College will be recruited for the study 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DIERS Formetric 4DTM Raster-stereographic / Surface Topography system   Surface Topography systems use the technique of Raster-stereography to analyze and estimate the sagital spinal and pelvic postural parameters.  
Intervention  None  None 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  • Normal, Asymptomatic, healthy young adults of both genders.
• Members of the Malaysian - Chinese group should be the descendants of Chinese parents and grandparents on both maternal and paternal branches/lines
• 18 – 40 years of age
• Ability to give informed consent in English Language
 
 
ExclusionCriteria 
Details  1. Degenerative disc disease with/without herniation
2. Mechanical Back pain (Facet joint syndrome, Muscular injury, Ligamentous injury etc)
3. Osteoarthritis of spine
4. Spondylolisthesis
5. Recent general surgery (past 12 months)
6. Spondylosis
7. Scoliotic deformity
8. Pregnancy
9. Metabolic diseases
10. Neoplasm
11. Congenital Deformities
12. Spinal Injuries 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Postural parameters obtained from the Formetric 4D Surface Topographic System  Measured at the time of recruitment 
 
Secondary Outcome  
Outcome  TimePoints 
• Pelvic Tilt
• Pelvic Torsion
• Pelvic Inclination
• Kyphotic Angle
• Lordotic Angle
• Surface Rotation
 
Measured at the time of recruitment 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/06/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Need of the study:

The sagittal plane contour of the spine plays an important role in the normal function of the spine. Maintenance of the sagittal spino-pelvic balance is found to be the result of combined effort of osteo-articular and myo-fascial structures of the spinal column, the pelvis and the lower limb muscles. A proper assessment of spinal posture can facilitate early detection of postural aberrations and institution of adequate preventive and corrective measures.1.2

Human population is subdivided into a plethora of ethnic groups and races distributed worldwide. An ethnic group or ethnicity is a socially defined category of people who identify with each other based on common ancestral, social, cultural or national experience3, whereas Race, as a social concept, is a group of people who share similar and distinct physical characteristics such as bone structure and skin, hair, or eye color.4

Ethnicity plays an important role in the differentiation of anthropometric values.5 Multiple studies have been described in the literature that have analyzed the inter- ethnic anthropometric and spinal postural parametric differences in humans as well as in cadavers. 5 – 9 But based on these studies it is still unclear whether or not race plays a role in the variability of pelvic morphology and spino-pelvic anatomy.

Malaysia is a multi-racial country with more than 70 identified ethnic groups. These ethnic groups are broadly classified into four major groups namely Bumiputera (inclusive of Malay and Indigenous), Chinese, Indians and Others (include non-Malaysian citizen). The Chinese Malaysians are Malysian citizens of Han Chinese ancestry, descendents of Han Chinese who arrived between the early and mid-20th century. They constitute about 22.9 per cent of the entire Malaysian population.10

For the detection of changes in spinal posture, the gold standard remains to be , the clinical examination along with radiological techniques such as X Ray, CT and MRI until today. The radiation from these diagnostic procedures leads to a very critical deployment for conducting multiple examinations, particularly in young individuals. For this reason, simple, but inaccurate and poorly reliable methods were developed for spinal postural analysis like the kyphometer or the curve ruler. 11

A precise radiation free and inexpensive method for detecting the spinal posture was then developed in early 1980’s, called Surface Topography, based on the technology of Raster-stereography (RSG). The surface contour analysis occurs from the projection of raster lines on the back of the patient. Assignment of concave and convex areas to curved light patterns enables automatic detection of anatomical landmarks. The system is able to calculate a 3D model of the human spine, by means of certain anatomical fixed points of the human body. Clinically relevant spinal and pelvic postural parameters such as the trunk inclination, the kyphosis and the lordosis angles of the spine can be determined by this technique. Thus surface topography offers an alternative method of detecting spinal postural parameters because it is side effect and contact-free, non invasive, fast and objective.11

The differences in spinal and pelvic postural parameters in two different racial groups obtained using the non- invasive and radiation free technology of Surface Topography haven’t been previously analyzed. The aim of the present study is to describe the spinal and pelvic postural parameters in a sample of healthy Chinese-origin Malaysian volunteers and to compare with that obtained from an age matched healthy Indian population. Our findings may provide greater insight into the influence of ethnicity or racial differences in assessment of spinal posture as well as management of spinal disorders.

 
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