| CTRI Number |
CTRI/2024/02/062353 [Registered on: 06/02/2024] Trial Registered Prospectively |
| Last Modified On: |
21/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study for satisfaction related to artificial limb in lower limb amputees |
|
Scientific Title of Study
|
A study to evaluate patient satisfaction with prosthesis in lower limb amputees : A CROSS SECTIONAL 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 |
Arjit Bansal |
| Designation |
post graduate student |
| Affiliation |
PGIMER(post graduate institute of medical education and research ), Chandigarh |
| Address |
Department of orthopaedics, PGIMER (post graduate institute of medical education and research ), Sector-12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7610949488 |
| Fax |
|
| Email |
Arjitbansal28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Himanshu Bhayana |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER(post graduate institute of medical education and research ), Chandigarh |
| Address |
Department of orthopaedics, PGIMER(post graduate institute of medical education and research ), Sector-12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9599149380 |
| Fax |
|
| Email |
himanshu.bhayana.mamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arjit Bansal |
| Designation |
PG student |
| Affiliation |
PGIMER( post graduate institute of medical education and research, Chandigarh |
| Address |
Department of orthopaedics, PGIMER( post graduate institute of medical education and research) , Sector-12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7610949488 |
| Fax |
|
| Email |
Arjitbansal28@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER( post graduate institute of medical education and research, Sector-12 CHANDIGARH 160012 |
|
|
Primary Sponsor
|
| Name |
PGIMER post graduate institute of medical education and research Chandigarh |
| Address |
Sector-12, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Arjit Bansal |
PGIMER( post graduate institute of medical education and research, Chandigarh |
New OPD block, PGIMER ( post graduate institute of medical education and research) Sector-12, Chandigarh
Chandigarh
CHANDIGARH |
7610949488
Arjitbansal28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ( post graduate institute of medical education and research, chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 70 years, Lower limb amputees using prothesis for mobilisation for at least 6 months |
|
| ExclusionCriteria |
| Details |
Patients using prosthesis less than 6 months, patients not consenting for study, patients having amputation near hip or ankle joint, using prosthesis for less than 8 hours, having bilateral amputation, patient having spinal injury, non ambulatory patient |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Estimation of patient satisfaction regarding the prosthesis Using TAPES-R |
6 Months after prosthesis use |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Estimation of patient satisfaction regarding the prosthesis use, using a modified version of TAPES-R in lower limb amputees in terms of physical, psychological and social aspects.
2. To enlist the complications and difficulties encountered while using the prosthesis in these patients.
3. To study the association of satisfaction regarding the prosthesis use with the psychological comorbidities like anxiety, depression, etc. in these patients using HADS (Hospital Anxiety and Depression Scale).
4. To study the association of demographic variables with the satisfaction regarding the prosthesis use.
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
10/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/02/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Patients will be recruited using the recruitment process as shown and after recruitment informed consent form will be given and questionnaire called TAPES(Open access score) regarding the prosthesis will be handed over to patient which will be filled by the patient with the assistance of the investigator, satisfaction of the patient regarding the prosthesis will be calculated with the help of scoring present in the questionnaire. An interdisciplinary group consisting of orthopaedic surgeons, a psychiatrist, a physiotherapist, an orthopaedic technician, a nursing officer and a statistician designed the proforma and modified the questionnaire. The questionnaire was translated from English to Hindi and Punjabi by 3 Experts working at PGIMER and verified according to WHO protocol. Initial translations were performed independently and then discussed for any discrepancies and the questionnaire was back-translated from Punjabi and Hindi to English by a fourth translator. The back-translation was compared with the original English version. The validation of the Hindi and Punjabi version of the score will be done during the course of recruitment once we reach half of the targeted sample size. The additional questions added to the original questionnaire will be validated in a similar manner. The questionnaire will have a score attached to each answer and a total score is calculated for each sub heading denoting the satisfaction related to the prosthesis (questionnaire attached in annexures). HADS will be used for estimating the prevalence of anxiety and depression in the patients. |