| CTRI Number |
CTRI/2024/05/067453 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Lower limb amputation its effect on Quality of Life and Body Image in Amputee Individual |
|
Scientific Title of Study
|
ANALYSIS OF HEALTH RELATED QUALITY OF LIFE (HRQOL) AND ITS ASSOCIATION WITH BODY IMAGE AMONG COMMUNITY DWELLING LOWER LIMB AMPUTEE INDIVIDUALS A CROSS SECTIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SWATI G ADE |
| Designation |
1st year MPT(community physiotherapy) |
| Affiliation |
Dr Vithalrao Vikhe Patil college of physiotherapy Ahmednagar |
| Address |
Department of Community Physiotherapy Basement Dr Vithalrao
Vikhe Patil college of physiotherapy vilad ghat Ahmednagar MAHARASHTRA 414111 India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9049092469 |
| Fax |
|
| Email |
swatiade1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyam D Ganvir |
| Designation |
Principal & Professor Department of Community Physiotherapy |
| Affiliation |
Dr Vithalrao Vikhe Patil college of physiotherapy Ahmednagar |
| Address |
Department of Community Physiotherapy Basement Dr Vithalrao
Vikhe Patil college of physiotherapy vilad ghat
Ahmadnagar MAHARASHTRA 414111 India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9373566683 |
| Fax |
|
| Email |
shyam.ganvir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyam D Ganvir |
| Designation |
Principal & Professor Department of Community Physiotherapy |
| Affiliation |
Dr Vithalrao Vikhe Patil college of physiotherapy Ahmednagar |
| Address |
Department of Community Physiotherapy Basement Dr Vithalrao
Vikhe Patil college of physiotherapy vilad ghat
Ahmadnagar MAHARASHTRA 414111 India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9373566683 |
| Fax |
|
| Email |
shyam.ganvir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Community Physiotherapy DVVPFs college of physiotherapy Ahmednagar |
|
|
Primary Sponsor
|
| Name |
DVVPFS College of Physiotherapy Ahmednagar |
| Address |
DVVPFS COLLEGE OF PHYSIOTHERAPY opposite govt milk dairy
micd vilad ghat Ahmednagar MAHARASHTRA 414111 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Swati ade |
Community |
surgery wards, Tertiary care Hospitals Ahmadnagar 414111
Ahmadnagar
MAHARASHTRA |
9049092469
swatiade1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DVVPFS College of Physiotherapy Institutional ethical Committe Ahmednagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Lower limb amputation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients either having unilateral/ bilateral lower limb amputation.2.A lower limb amputation has occurred within last three years for the patient. |
|
| ExclusionCriteria |
| Details |
1.Patients with different diagnoses
2.Unwilling to participate
ï¬3.Psychological disorders and cognitive impairment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 SF-36 quality of life
2 The Amputee Body Image Scale(ABIS) |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
01/07/2024 |
| 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="1"
Months="0"
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
|
Poor quality of life and body image and difficulties in all ADL’s and decrease in muscle strength and power. this study aimed to out association of health -related quality of life and body image in lower limb amputee individual, which could be beneficial for improving quality of life and body image. |