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CTRI Number  CTRI/2025/07/090424 [Registered on: 08/07/2025] Trial Registered Prospectively
Last Modified On: 04/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment of Knowledge, attitude and practice about use of sternal binders post sternotomy in cardiac Physiotherapists practicing in in Maharashtra 
Scientific Title of Study   Knowledge, attitude and practice about use of sternal binders post sternotomy in Physiotherapists practicing in cardiac setup in Maharashtra 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aditi L Soman 
Designation  Assistant Professor 
Affiliation  Deccan Education Society’s, Brijlal Jindal College of Physiotherapy, Pune 
Address  D.E. Societys Brijlal Jindal college of Physiotherapy, Pune

Pune
MAHARASHTRA
411005
India 
Phone  918788123192  
Fax    
Email  aditi.soman@despune.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr SejalHaswani 
Designation  PG Student 
Affiliation  Deccan Education Society’s, Brijlal Jindal College of Physiotherapy, Pune 
Address  D.E. Societys Brijlal Jindal college of Physiotherapy, Pune

Pune
MAHARASHTRA
411005
India 
Phone  918788123192  
Fax    
Email  sejal.haswani961@deccansociety.org  
 
Details of Contact Person
Public Query
 
Name  Dr Aditi L Soman 
Designation  Assistant Professor 
Affiliation  Deccan Education Society’s, Brijlal Jindal College of Physiotherapy, Pune 
Address  D.E. Societys Brijlal Jindal college of Physiotherapy, Pune
Department of Cardiovascular and Respiratory Physiotherapy, Ground Floor
Pune
MAHARASHTRA
411005
India 
Phone  918788123192  
Fax    
Email  aditi.soman@despune.org  
 
Source of Monetary or Material Support  
Department of Cardiovascular and Respiratory Physiotherapy, Ground Floor, D.E. Societys Brijlal Jindal College of Physiotherapy, Shivajinagar, Pune 
 
Primary Sponsor  
Name  nil 
Address  self funded 
Type of Sponsor  Other [self funded] 
 
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 
Dr Sejal Haswani  Community setting  it will be a telephonic interview of cardiac physiotherapist in Maharashtra
Pune
MAHARASHTRA 
917264098961

sejal.haswani961@deccansociety.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DECCAN EDUCATION SOCIETYS BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  nil 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  23.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Licensed Physiotherapists involved in acute post surgical cardiac rehab.
PT involved in phase one rehab program.
PT having experience of more than 2 years in cardiac rehab. 
 
ExclusionCriteria 
Details  PT not involved in acute phase of post surgical rehabilitation program.
PT having experience of less than 2 years in acute phase of cardiac rehab.
Students or interns. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
self designed questionnaire  only once 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
Target Sample Size   Total Sample Size="133"
Sample Size from India="133" 
Final Enrollment numbers achieved (Total)= "133"
Final Enrollment numbers achieved (India)="133" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/08/2025 
Date of Study Completion (India) 30/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Median sternotomy is considered to be the gold standard incision in cardiac and thoracic surgical procedures. Despite its advantages, the prevalence of sternal complications has remained relatively unchanged over the past two decades, ranging from 0.4 percent to 8 percent worldwide. Sternal binders are given to the patients to prevent complications like sternal instability, dehiscence and pain. However, sternal binders are prescribed to all patients over a standard timeframe without considering individual differences, risk factors for complications, clinical recovery status. There are also inconsistencies in the type of prescribed binders and the timing of prescription. These inconsistencies may be due to lack of standardised guidelines for the indications, benefits, risk factors and appropriate application of sternal binders potentially compromising patient outcomes. Limited research exists addressing the knowledge, attitude and practice of physiotherapists regarding sternal binders. The aim of this study is to assess knowledge, attitude and practice regarding the use of sternal binders post sternotomy among physiotherapists practicing in cardiac setup in Maharashtra and to address the knowledge gap and variability in practice. A cross sectional analytical study with convenient sampling will be conducted over 12 months with 133 participants. A self-designed questionnaire is developed and validated to assess the knowledge, attitude and practice. Descriptive statistical analysis will be used to interpret the results.  

 
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