| 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
|
|
|
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
|
|
|
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
|
|
|
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 |
|
|
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. |