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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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