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CTRI Number  CTRI/2020/01/022828 [Registered on: 16/01/2020] Trial Registered Prospectively
Last Modified On: 04/11/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Influence of upper back curve on neck movements 
Scientific Title of Study   Influence of Thoracic Curvature and mobility on cervical range of motion 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ganesh Balthillaya 
Designation  Assistant Professor(senior scale) 
Affiliation  MCHP, Manipal Academy of Hgher Education Manipal 
Address  Department of Physiotherapy MCHP, MAHE, Manipal ,Udupi, Karnataka

Udupi
KARNATAKA
576107
India 
Phone  9448263631  
Fax    
Email  ganesh.bm@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Ganesh Balthillaya 
Designation  Assistant Professor(senior scale) 
Affiliation  MCHP, Manipal Academy of Hgher Education Manipal 
Address  Department of Physiotherapy MCHP, MAHE, Manipal ,Udupi, Karnataka

Udupi
KARNATAKA
576107
India 
Phone  9448263631  
Fax    
Email  ganesh.bm@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Ganesh Balthillaya 
Designation  Assistant Professor(senior scale) 
Affiliation  MCHP, Manipal Academy of Hgher Education Manipal 
Address  Department of Physiotherapy MCHP, MAHE, Manipal ,Udupi, Karnataka

Udupi
KARNATAKA
576107
India 
Phone  9448263631  
Fax    
Email  ganesh.bm@manipal.edu  
 
Source of Monetary or Material Support  
Manipal collage of Health professions. MAHE, Manipal, Udupi,Karnataka 
 
Primary Sponsor  
Name  Manipal collage of health professions 
Address  MCHP, MAHE Manipal, Udupi 
Type of Sponsor  Research institution and hospital 
 
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 
Ganesh Balthillaya M  MCHP, Manipal  Department of physiotherapy Manipal ,Udupi, Karnataka
Udupi
KARNATAKA 
9448263631

ganesh.bm@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical college and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Male and Female between age 20 to 40 years
 
 
ExclusionCriteria 
Details  musculoskeletal conditions of shoulder and neck 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cervical Range of Motion  Only once at the time of recruitment 
 
Secondary Outcome  
Outcome  TimePoints 
thoracic curvature  one time 
 
Target Sample Size   Total Sample Size="47"
Sample Size from India="47" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/01/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nill 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Thoracic spine is the base of support for neck and upper limb. Change in position of thoracic spine may affect the cervical range of motion and which may cause dysfunction of cervical spine.. Aim of this study is to find out is there any relation ship between thoracic curvature and mobility with cervical range of motion. The cervical range of motion will be measured with help of CROM and thoracic curve and range will be assesd with flexicurve.Corelation between cervical range and thoracic curvature angle will be calculated. 
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