| CTRI Number |
CTRI/2024/04/066296 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A CrossSectional To Assess The Quality Of Life Among Lower-Limb Amputees In A Tertiary Care Institution In Western Rajasthan. |
|
Scientific Title of Study
|
Assessment Of Quality Of Life Among Lower Limb Amputees In The Tertiary Care Center Of Western Rajasthan: A Cross-sectional Survey |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohit kumar |
| Designation |
MPH Scholar |
| Affiliation |
AIIMS |
| Address |
Second Floor, Academic Building, Department of School of Public Health, Room no. 148, Industrial Phase Basni Rajasthan
AIIMS Jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9463858224 |
| Fax |
|
| Email |
rohitjagrit97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravi Gaur |
| Designation |
HOD |
| Affiliation |
AIIMS |
| Address |
Ground Floor PMR Department Industrial Phase Basni Jodhpur
AIIMS ,Jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
8299711753 |
| Fax |
|
| Email |
ravisms80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manoj Kumar Gupta |
| Designation |
Additional Professor |
| Affiliation |
AIIMS |
| Address |
2 Floor Community Medicine Department AIIMS Jodhpur
AIIMS ,Jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
8003996087 |
| Fax |
|
| Email |
drmkgbhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Industrial Phase Basni Jodhpur Rajasthan
|
|
|
Primary Sponsor
|
| Name |
Rohit kumar |
| Address |
2 Floor Academic Block School Of Public Health Department Industrial Phase Basni AIIMS Jodhpur |
| 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 Ravi Gaur |
AIIMS Jodhpur |
Ground Floor PMR Department Room no 4 Industrial Phase Basni
Jodhpur
RAJASTHAN |
8299711753
ravisms80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S789||Traumatic amputation of hip and thigh, level unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Lower Limb Amputation Older Than 18 Years And Undergone Amputation During The Last Five Years From The Day Of Surgery (And More Than Then 6 Months Since Surgery |
|
| ExclusionCriteria |
| Details |
Multiple Amputations and Small Toe Amputation
Various Chronic Condition Such As HIV Psychological Illness TB
Who Refuse To Give Consent |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Understanding Quality Of Life
Identifying Factors That Influence Quality of life
Prosthesis Experience
Phantom Limb Pain and Residual Limb Pain
Informing Interventions
Prosthesis Experience |
2 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Various Difficulties Associated With Prosthesis |
2 Months |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
05/05/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 quality of life among lower limb amputees in a tertiary care centre
in western Rajasthan. The research will be conducted over a two-month period,
with the primary objective of assessing the quality of life among patients
reporting to AIIMS Jodhpur. The secondary objective is to identify
complications with the usage of different prosthesis for lower limb amputees,
the experience of prosthesis use, and record data regarding phantom limb pain
and residual limb pain. The study will include lower limb amputees older than
18 years and undergone amputation within the last five years. Exclusion
criteria includes multiple amputation or minor amputation involving toes,
amputees with other chronic illnesses, psychiatric illnesses, or patients who
refused to give consent. The study aims to provide a comprehensive
understanding of the quality of life among lower limb amputees in Western
Rajasthan, identify factors influencing their quality of life, inform targeted
interventions, and guide future research in this area, particularly in tertiary
care centres in Rajasthan. |