| CTRI Number |
CTRI/2025/10/096219 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
19/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PILOT STUDY |
| Study Design |
Other |
|
Public Title of Study
|
ICF Coreset for Dentists |
|
Scientific Title of Study
|
Development And Validation of ICF Coreset for Assessment of Caregiver Burden in Professional Caregivers. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrVijayalaxmi Kanabur |
| Designation |
Assisstant Professor |
| Affiliation |
KAHER Institute of Physiotherapy,Belagavi |
| Address |
Advanced Physiotherapy Centre,Sagar Floor,KLE Dr.Prabhakar Kore Hospital and MRC,Nehru Nagar,Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
08867480565 |
| Fax |
|
| Email |
vvkdeeksha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVijayalaxmi Kanabur |
| Designation |
Assisstant Professor |
| Affiliation |
KAHER Institute of Physiotherapy,Belagavi |
| Address |
Advanced Physiotherapy Centre,Sagar Floor,KLE Dr.Prabhakar Kore Hospital and MRC,Nehru Nagar,Belagavi
KARNATAKA
590010
India |
| Phone |
08867480565 |
| Fax |
|
| Email |
vvkdeeksha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lingraj Umrani |
| Designation |
Intern |
| Affiliation |
KAHER Institute of Physiotherapy,Belagavi |
| Address |
Advanced Physiotherapy Centre,Sagar Floor,KLE Dr.Prabhakar Kore Hospital and MRC,Nehru Nagar,Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9343774511 |
| Fax |
|
| Email |
lingrajumrani04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Prabhakar KOre Hospitaland MRC,Nehru Nagar Belagavi-590010 |
|
|
Primary Sponsor
|
| Name |
lingraj Umarani |
| Address |
Advanced Physiotherapy Centre,Sagar Floor,KLE Dr.Prabhakar Kore Hospital and MRC,Nehru Nagar,Belagavi, Karnataka, India -590010 |
| Type of Sponsor |
Other [SELF SPONSORED] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Neha Shede |
No:39,Advanced Physiotherapy Centre,Sagar Floor,KLE Dr.Prabhakar Kore Hospital and MRC,Nehru Nagar,Belagavi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| NEHA SHEDE |
KLE DR PRABHAKAR KORE HOSPITAL . |
No:39,Advanced Physiotherapy Centre,Sagar Floor,KLE Dr.Prabhakar Kore Hospital and MRC,Nehru Nagar,Belagavi
Belgaum
KARNATAKA |
9371340679
shedeneha2411@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE,KAHER INSTITUTE OF PHYSIOTHERAPY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
CAREGIVERS WITH STRESS,BURDEN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Professional Caregivers of all genders between the age group of 20-45 years.Minimum Experience of 2 years and in active caregiving task at least from 6 months.Caregivers with no injury hampering self-functioning level for 6 months.
|
|
| ExclusionCriteria |
| Details |
Care givers not consenting to participate in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Newly developed ICF core set |
0 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
Final Enrollment numbers achieved (Total)= "51"
Final Enrollment numbers achieved (India)="51" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/10/2025 |
| Date of Study Completion (India) |
03/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
The development and validation of an ICF-based
caregiver burden assessment tool (ICF Corset), will contribute significantly to
advancing caregiver research. It will provide reliable evidence to improve
intervention strategies, support systems, and policies aimed at sustaining
professional caregivers’ wellbeing. Ultimately, this will not only preserve
caregiver health but also enhance the quality of care provided to vulnerable
populations. |