| 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
|
|
|
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
|
|
|
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. |