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CTRI Number  CTRI/2024/05/068175 [Registered on: 31/05/2024] Trial Registered Prospectively
Last Modified On: 17/02/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Hand Function Assessment Tool for Hindi-Speaking Rheumatoid Arthritis Patients 
Scientific Title of Study   Development and Validation of Hindi Hand Function Assessment Tool in Rheumatoid Arthritis Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neetu Mahapatra 
Designation  Professor 
Affiliation  MAEERS physiotherapy college 
Address  MAEERs Physiotherapy College, Musculoskeletal Department Room no A-207,OPD building 2nd Floor, Near talegaon railway station, talegaon db

Pune
MAHARASHTRA
410507
India 
Phone  9823236752  
Fax    
Email  neetu@mitmimer.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neetu Mahapatra 
Designation  Professor 
Affiliation  MAEERS physiotherapy college 
Address  MAEERs physiotherapy college, Musculoskeletal Physiotherapy Department Room no-A-207,OPD building,2nd Floor,Near talegaon railway station, talegaon db


MAHARASHTRA
410507
India 
Phone  9823236752  
Fax    
Email  neetu@mitmimer.com  
 
Details of Contact Person
Public Query  
Name  Dr Neetu Mahapatra 
Designation  Professor 
Affiliation  MAEERs physiotherapy college 
Address  MAEERs physiotherapy college, Near talegaon railway station, talegaon db

Pune
MAHARASHTRA
410507
India 
Phone  9823236752  
Fax    
Email  neetu@mitmimer.com  
 
Source of Monetary or Material Support  
MAEERs Physiotherapy College, Musculoskeletal Physiotherapy Department, Room no.A-207, OPD building,2nd Floor.near Railway station,Talegaon Dabhade.Pune District.Maharashtra,India.410507  
 
Primary Sponsor  
Name  MAEERs Physiotherapy College 
Address  Musculoskeletal Physiotherapy Department,Room no A-207,OPD Building 2nd floor near Railway station Talegaon Dabhade.Pune District.Maharashtra.India.410507 
Type of Sponsor  Private medical college 
 
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 Snehal Ghodey  BSTRH hospital and MAEERs physiotherapy opd  Musculoskeletal Physiotherapy Department,Room no A-207,OPD building,2nd Floor, Near railway station, talegaon db.410507
Pune
MAHARASHTRA 		 9422326959

gsnehavi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAEERs Physiotherapy College Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Clinically diagnosed RA patients with hand & wrist involvement
RA stage 2 & 3
Disease duration more than 1 year
patient who can understand and speak Hindi 
 
ExclusionCriteria 
Details  Patients with Neurological disorders
Neuropathies
recent upper limb surgery (less than 1 year)
Recent upper limb trauma (less than 1 yr)
patient who cant participate in repeated measures
Any other inflammatory joint diseases
cervical radiculopathy and spondylosis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
content and construct validity   Baseline  
 
Secondary Outcome  
Outcome  TimePoints 
Reliability  Baseline and Day 7 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Introduction: Many complex hand function tests are available to assess function in individuals with RA. however, do not comprehensively assess Indian scenario ADLs, Environmental factors, and household chores. No Hindi version currently exists despite being the most spoken (43.63%) language in India. This Cultural diversity necessitates the development of a culturally sensitive Hand assessment scale for RA patients with an Indian cultural background

Purpose: To Develop & Validate the Indian Hand Function Assessment Tool in Hindi-speaking RA patients

b)    Materials & Methods:

Study Design: Cross-sectional (validation study), Study Setting: PAN India (Rheumatoid arthritis societies, OPD settings).After focus group discussion Items will be generated and after expert panel consensus via the Delphi method preliminary questionnaire will be prepared..Content validity will be assessed using CVR & Face validity will be assessed by Item Impact score. pretesting will be done on 30 RA patients and the final version will be tested for measurement properties for construct validity (Spearman’s Correlation Coefficient) with Hindi DASH & VAS, Reliability (ICC), Internal consistency (Cronbach’s Alpha) in 250 Hindi-speaking Rheumatoid Arthritis patients.

 
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