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CTRI Number  CTRI/2024/01/061955 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 20/11/2025
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 Pulmonary Functional Status and Dyspnea Questionnaire - Modified in Hindi  
Scientific Title of Study   Cross-Cultural Adaptation and Validation of Hindi Version of Pulmonary Functional Status Questionnaire - Modified(PFSDQ-M) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Urvashi 
Designation  MPT Student 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana

Ambala
HARYANA
133207
India 
Phone  9466282249  
Fax    
Email  chauhanurvi17@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mandeep Kumar Jangra PT 
Designation  Assistant Professor 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana

Ambala
HARYANA
133207
India 
Phone  9813397708  
Fax    
Email  mandeep.jangra@mmumullana.org  
 
Details of Contact Person
Public Query  
Name  Dr Mandeep Kumar Jangra PT 
Designation  Assistant Professor 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana

Ambala
HARYANA
133207
India 
Phone  9813397708  
Fax    
Email  mandeep.jangra@mmumullana.org  
 
Source of Monetary or Material Support  
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana 
 
Primary Sponsor  
Name  Urvashi 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana 
Type of Sponsor  Other [Self] 
 
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 Urvashi PT  Maharishi Markandeshwar Super Speciality Hospital, Mullana  A-8, Chest and TB ward
Ambala
HARYANA 		 9466282249

chauhanurvi17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decision of the Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Both male and female.
Age 18 to 75 years.
Diagnosed case of COPD
Sufficient cognitive ability to comprehend the questionnaire
 
 
ExclusionCriteria 
Details  Psychiatric disorders
Communicatve and coginitive deficits
Presence of complications
Un-cooperative patients
Patients who don’t give consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/02/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

Ethical approval of this study will taken from the student project committee of Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandehwar (Deemed to be University). Study will be accordance with Helsinki Declaration Revised 2013 and the National Ethical Guidelines for Biomedical Research involving Human Participation, 2017.

This study involves the translation of Pulmonary Functional Status and Dyspnea Questionnaire- Modified (PFSDQ-M) into Hindi language. There will be two phases of the study- 1st PHASE includes- Translation and validation of questionnaire according to DE Beaton guidelines having total five stages involve, Stage 1- Initial translation (Forward translation) into target (Hindi) language by two translators T1 and T2. Stage 2- synthesis of T1 and T2 into T12. Stage 3- back translation of T12 into original language(English) by two translator BT1 and BT2. Stage 4- involve Expert committee review and produce Pre-final version. Stage 5- Pretesting on 30 to 40 subject  for understanding the item including into the translated questionnaire. 2NDPHASE includes- cross-cultural adaptation by test-retest reliability.

 
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