| CTRI Number |
CTRI/2024/06/068466 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
25/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Translation and validation of Peripheral Artery Disease Quality of Life Questionnaire into Nepali language |
|
Scientific Title of Study
|
Cross-cultural Adaptation of Peripheral Artery Disease Quality of Life Questionnaire (PADQOL)into Indian Nepali Language |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Niyar Snigdha Pathak |
| Designation |
PG student |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Sikkim Manipal College of Physiotherapy ,Sikkim Manipal University, ground floor (room no.2),5th Mile, TADONG, Gangtok
East SIKKIM 737102 India |
| Phone |
7002266241 |
| Fax |
|
| Email |
niyarsnigdha@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Niyar Snigdha Pathak |
| Designation |
PG Student |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Sikkim Manipal College of Physiotherapy, Sikkim Manipal university, ground floor (room no.2),5th Mile, TADONG, Gangtok
East SIKKIM 737102 India |
| Phone |
7002266241 |
| Fax |
|
| Email |
niyarsnigdha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prof Nikita Joshi Sonowal PT |
| Designation |
Head of Dept., Principal SMCPT |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Sikkim Manipal College of Physiotherapy, Sikkim Manipal university, ground floor (room no.2),5th Mile, TADONG, Gangtok
East SIKKIM 737102 India |
| Phone |
9932470754 |
| Fax |
|
| Email |
principal.physiotherapy@smims.smu.edu.in |
|
|
Source of Monetary or Material Support
|
| Central Referral Hospital |
|
|
Primary Sponsor
|
| Name |
Central Referral Hospital |
| Address |
fitness department of Physiotherapy, level 5, 5th mile, Tadong, East Sikkim, India, PIN- 737102 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Niyar Snigdha Pathak PT |
Central Referral Hospital |
Department of physiotherapy, level 5th, Central Referral Hospital, 5th mile Tadong, Gangtok, East Sikkim, Sikkim, India East SIKKIM |
7002266241
niyarsnigdha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sikkim Manipal Institute of Medical Sciences Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I738||Other specified peripheral vascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients with Peripheral Artery Disease, Ankle Brachial Index ≤ 0.9, Individuals who can read both Nepali and English |
|
| ExclusionCriteria |
| Details |
Recent major lower limb surgery, foot or leg amputation, cognitive impairment, unwillingness to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Peripheral Artery Disease Quality of Life Questionnaire
|
at baseline and 1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Short Form 36 |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="192" Sample Size from India="192"
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)
|
12/06/2024 |
| 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)
|
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
|
Peripheral artery disease (PAD) is a condition where arteries that carry blood from the heart to the limbs become narrowed due to plaque buildup. This narrowing, known as stenosis, restricts blood flow, leading to symptoms like leg pain during physical activity, known as claudication. If left untreated, PAD can progress to more severe symptoms, such as pain at rest, non-healing wounds, and even limb amputation. It also increases the risk of heart attacks and strokes. Risk factors for PAD include smoking, diabetes, high blood pressure, high cholesterol, and aging. Studies in India have shown varying prevalence rates, with Kerala and Sikkim reporting significant numbers of cases, often associated with high cholesterol, hypertension, diabetes, and smoking. To better understand how PAD affects quality of life in the Indian Nepali population, The Peripheral Artery Disease Quality of Life (PADQOL) Questionnaire was translated and cross culturally adapted by using Beaton’s guideline. To determine validity and reliability of the questionnaire PADQOL, it will be applied on 192 patients with Peripheral Artery Disease meeting the eligibility criteria and after a wash out period of 24 hrs it will be applied again on the same patients along with SF 36. after the completion of the procedure data will be analyzed by using SPP version 27. The translated questionnaire provides healthcare providers with a culturally sensitive tool to assess and address the impact of PAD on patients’ lives, ultimately improving care and outcomes for the Indian Nepali community affected by this condition. |