| CTRI Number |
CTRI/2025/07/090506 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing Family Quality of Life in Households of Lower Limb Amputees |
|
Scientific Title of Study
|
Assessing Family Quality of Life in Households of Lower Limb Amputees: An Observational study |
| 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 Sibani Priyadarsini |
| Designation |
MOT, Assistant Professor, Head of Department of Occupational Therapy |
| Affiliation |
KAHER Institute of Physiotherapy, Belagavi |
| Address |
Department of Occupational Therapy, 2nd floor, OPD wing, KLES Prabhakar Kore Hospital and Research Centre, Nehru Nagar, Belgaum, Karnataka, India, 590010
KAHER Institute of Physiotherapy, Nehru Nagar, Belgaum, Karnataka, India, 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8984477619 |
| Fax |
|
| Email |
sibani1795@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sibani Priyadarsini |
| Designation |
MOT, Assistant Professor, Head of Department of Occupational Therapy |
| Affiliation |
KAHER Institute of Physiotherapy, Belagavi |
| Address |
Q no A 10-6, JNMC campus, Nehru Nagar, Belgaum, Karnataka
KAHER Institute of Physiotherapy, Nehru Nagar, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8984477619 |
| Fax |
|
| Email |
sibani1795@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sibani Priyadarsini |
| Designation |
MOT, Assistant Professor, Head of Department of Occupational Therapy |
| Affiliation |
KAHER Institute of Physiotherapy, Belagavi |
| Address |
Department of Occupational Therapy, 2nd floor, OPD wing, KLES Prabhakar Kore Hospital and Research Centre, Nehru Nagar, Belgaum, Karnataka, India, 590010
KAHER Institute of Physiotherapy, Nehru Nagar, Belgaum, Karnataka, India, 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8984477619 |
| Fax |
|
| Email |
sibani1795@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Institute of Physiotherapy, Belagavi, Karnataka, India, 590010 |
|
|
Primary Sponsor
|
| Name |
Kian F Gandhi |
| Address |
KAHER Institute of Physiotherapy, Belagavi, Karnataka, India, 590010 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sibani Priyadarsini |
KLES Prabhakar Kore Hospital and Research Centre |
Department of Occupational Therapy, 2nd floor, OPD wing.
Belgaum
KARNATAKA |
8984477619
sibani1795@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee of KAHER Institute of Physiotherapy, Belagavi, Karnataka, India, 590010 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
- Families of individuals who have undergone lower limb amputations.
- Willing to provide informed consent. |
|
| ExclusionCriteria |
| Details |
- Families of individuals with acute cases of amputation.
- Families of individuals who have undergone of other body parts also. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Beach Centre Family Quality of Life Scale |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="49"
Sample Size from India="49"
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)
|
19/07/2025 |
| 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="0"
Months="6"
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
|
The study aims to assess the Family Quality of Life of individuals who have undergone lower limb amputations. The validated questionnaire will be provided to 1 of the family members, and the data will be collected through interview. The data will then be collected and analysed. |