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CTRI Number  CTRI/2025/06/088374 [Registered on: 06/06/2025] Trial Registered Prospectively
Last Modified On: 06/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Translation study 
Study Design  Other 
Public Title of Study   Making a Kannada Version and to find the accuracy of Caregiver Burden Inventory - Spinal Cord Injury Questionnaire to Understand the Challenges Faced by Caregivers of Spinal Cord Injury Patients in Karnataka, India 
Scientific Title of Study   Kannada Translation and Content Validation of Caregiver Burden Inventory- Spinal Cord Injury Scale For Immediate Caregiver of Spinal Cord Injury Survivors Karnataka, India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vimith V Saldanha 
Designation  MPT Neurosciences 
Affiliation  Father muller college of physiotherapy 
Address  Father muller college of physiotherapy kankanady mangalore 575002

Udupi
KARNATAKA
575002
India 
Phone  06361324448  
Fax    
Email  vimithflarishsaldanha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ms Rinku Roshan 
Designation  Assistant professor  
Affiliation  Father muller college of physiotherapy 
Address  Father muller college of physiotherapy kankanady mangalore 575002

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9945935788  
Fax    
Email  rinkurosh777@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ms Rinku Roshan 
Designation  Assistant professor  
Affiliation  Father muller college of physiotherapy 
Address  Father muller college of physiotherapy kankanady mangalore 575002

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9945935788  
Fax    
Email  rinkurosh777@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Father Muller college of Physiotherapy 
Address  Father muller college of physiotherapy, kankanady, mangalore - 575002 
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 
Vimith V Saldanha  Father Muller Medical College Hospital  R ward- physical medicine and rehabilitation 3rd floor geneeral ward, kankanady, mangalore
Dakshina Kannada
KARNATAKA 
06361324448

vimithflarishsaldanha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE (FMIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  caregivers of Spinal cord injury survivors 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Inclusion criteria is not applicable as my study does not any patients.  
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Caregiver burden inventory - spinal cord injury (CBI-SCI) Scale.   Kannada translation and content validation over 1 year of time duration 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="0"
Sample Size from India="0" 
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)   20/06/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

One of the major impairment causing illness that can leave people permanently disabled and make them unable to take care of themselves is spinal cord injury (SCI). The incidence of Spinal cord Injury varies between 11.5 and 57.8 per million worldwide. In India, there are between 15 to 20 million cases of SCI annually. The vast majority of SCI patients in India are from rural regions and are between the ages of 18 to 50. After their initial hospital stay, SCI survivors usually undergo rehabilitation at their home, which makes their immediate caregivers to handle the majority of the caregiving activities. For the caregivers, this caregiving duty usually results in considerable psychological stress and additional responsibilities apart from their personal activities. 

To maintain the disease-related health status and well-being of care recipients also to maintain their participation in the community, following the care of individuals with Spinal cord injury gives a significant amount of effort from their immediate family caregivers. Furthermore, the expenses associated with SCI and the requirement for ongoing support from care receivers may cause caregivers to experience financial decline, less social engagement, and an increase in their physical and emotional strain. The burden of caregivers can be influenced by cultural, ethical, religious, and other personal values, making it difficult for most academics to measure, despite the fact that there exist tools to do so.

Comprising of five subscales, the CBI-SCI self-reported questionnaire was created in 2019 to evaluate the effects of caregiver stress on many domains: time-dependent burden, developmental burden, physical burden, social burden, and emotional burden. As most of the SCI survivors are from rural backgrounds, a dearth of literature in outcomes that measure caregiver burden in a regional language for the people living in Karnataka, India. Hence there is a need to translate and validate outcomes for immediate caregivers of spinal cord injury survivors in Karnataka, India.

 
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