| CTRI Number |
CTRI/2022/09/045557 [Registered on: 15/09/2022] Trial Registered Prospectively |
| Last Modified On: |
09/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To see the level of independence in function and quality of life in patients who have lost their lower limb |
|
Scientific Title of Study
|
Functional Independence And Quality Of Life IN Individuals With Lower Limb Amputation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivaniben Rambhai Vala |
| Designation |
PG Student |
| Affiliation |
College of physiotherapy, Sumandeep Vidyapeeth |
| Address |
PG Classroom, On Ground Floor,College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At And Post Pipariya,Taluka-Waghodiya,Vadodara.
Vadodara
GUJARAT
391760
India |
| Phone |
7046344155 |
| Fax |
|
| Email |
shivanivala152sv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Mukkamala |
| Designation |
Associate Professor And Guide |
| Affiliation |
College of physiotherapy, Sumandeep Vidyapeeth |
| Address |
PG Staffroom, On Ground Floor,College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At And Post Pipariya,Taluka-Waghodiya,Vadodara.
PG Classroom, On Ground Floor,College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At And Post Pipariya,Taluka-Waghodiya,Vadodara.
Vadodara
GUJARAT
391760
India |
| Phone |
9898216184 |
| Fax |
|
| Email |
neha.cop@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Mukkamala |
| Designation |
Associate Professor And Guide |
| Affiliation |
College of physiotherapy, Sumandeep Vidyapeeth |
| Address |
PG Staffroom, On Ground Floor,College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At And Post Pipariya,Taluka-Waghodiya,Vadodara.
PG Classroom, On Ground Floor,College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At And Post Pipariya,Taluka-Waghodiya,Vadodara.
GUJARAT
391760
India |
| Phone |
9898216184 |
| Fax |
|
| Email |
neha.cop@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| This Is A Self Funded Study. The Infrastructure Is Provided By College Of Physiotherapy, Sumandeep Vidyapeeth-An Institution Deemed To Be University And Rehabs clinic, Vadodara-391760 Gujarat , India |
|
|
Primary Sponsor
|
| Name |
Shivaniben Rambhai Vala |
| Address |
PG Classroom, On Ground Floor,College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University, At And Post Pipariya,Taluka-Waghodiya,Vadodara. |
| 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 |
| Shivaniben Rambhai Vala |
Rehabs Clinic |
A-1 Maganlsai Appartments,Opposite Baroda High School, 84 Alkapuri PIN:390007
Vadodara
GUJARAT |
7046344155
shivanivala152sv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Rehabs clinic |
Approved |
| Sumandeep Vidyapeeth institutional ethics committee SVIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
>18 Years Of Age
> 6 Weeks After Amputation
Both Genders
Individuals with Hip disarticulation and knee disarticulation
Individuals With Transfemoral And Transtibial Amputation
Individuals With Unilateral And Bilateral Amputation |
|
| ExclusionCriteria |
| Details |
Total impairment of vision and hearing
Cognitive impaiment
Only upper limb amputation
Upper limb amputation
Upper limb amputation & lower limb amputation together
Ankle and foot amputation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
SF 12-Item short form health survey.
Timed Up and Go test |
at the time of assessment |
|
|
Secondary Outcome
|
|
|
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)
|
20/09/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
They will be explained about the study and those who are willing to participate will be requested to sign an informed consent . After signing the consent, Participant information sheet will be given. Individuals will be screened and assessed in details and those fulfilling the inclusion and exclusion criteria will be recruited for the study. The Test Procedure is as follows: First of all individuals will be screened as per the assessment format Then patient will be administered SF-12 questionnaire in their language for assessing quality of life and with & without prosthesis Then individuals will be assessed for TUG as follows. At the start of the test individuals will be seated on chair with back support and arm rest. Then on the command patient will be asked to stand up from chair and walk for 3M take a turn and complete the test and sit back on the chair. Patient will be commanded to walk at comfortable and normal walking pace. Pre and post vitals will be taken |