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CTRI Number  CTRI/2025/03/081973 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 06/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Translation,cross cultural adaptation ,reliability and validation 
Study Design  Other 
Public Title of Study   Translation of Lower Extremity Functional Scale into Kannada language and evaluation of its reliability and validity 
Scientific Title of Study   Linguistic validation of the Kannada language version of LEFS and its reliability 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lacquine D Souza 
Designation  Post graduate  
Affiliation  Nitte Institute Of Physiotherapy  
Address  Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru.

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9496557830  
Fax    
Email  lacquinedsouza@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Saumya srivastava 
Designation  associate professor 
Affiliation  Nitte Institute Of Physiotherapy  
Address  Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru.

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9740244077  
Fax    
Email  saumyasri2000@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Saumya srivastava 
Designation  associate professor 
Affiliation  Nitte Institute Of Physiotherapy  
Address  Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru.

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9740244077  
Fax    
Email  saumyasri2000@nitte.edu.in  
 
Source of Monetary or Material Support  
Department of physiotherapy room number 20,second base division and department of orthopaedics third floor,Justice K S hegde charitable hospital,medical science complex,Deralakatte,Mangalore,575018,Dakshina kannada ,Karnataka 
 
Primary Sponsor  
Name  Justice K S hegde charitable hospital 
Address  Department of physiotherapy room number 20,second base division and department of orthopaedics third floor,Justice K S hegde charitable hospital,medical science complex,Deralakatte,Mangalore,575018,Dakshina kannada ,Karnataka 
Type of Sponsor  Research institution 
 
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 Lacquine D Souza  Justice K S hegde hospital   Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru.
Dakshina Kannada
KARNATAKA 		 9496557830

lacquinedsouza@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committe Nitte institute of physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Individuals who are able to read and understand Kannada.
Individuals with various lower limb musculoskeletal conditions.
 
 
ExclusionCriteria 
Details  Individual with the communication problems.
Neurologic condition other than musculoskeletal pathologies.
Participants with any cognitive impairments, including dementia, traumatic brain injury, or mental retardation.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The Lower Extremity Functional Scale   At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
The Lower Extremity Functional Scale   After 24 hours ,after 48 hours 
 
Target Sample Size   Total Sample Size="101"
Sample Size from India="101" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="142" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/04/2025 
Date of Study Completion (India) 29/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   This study aims to translate and culturally adapt the Lower Extremity Functional Scale (LEFS) into Kannada and evaluate its reliability and validity. The translation process follows standard guidelines, including forward translation by two bilingual Kannada-native translators, synthesis of translations, back-translation by two bilingual English-native translators blinded to the original version, and expert committee review to finalize the adaptation. The pre-final version will be tested on patients with lower limb musculoskeletal conditions. For psychometric evaluation, informed consent will be obtained, and the LEFS-Kannada will be administered by two assessor with a one-hour interval and also data  will be collected at baseline and within 3 ± 2 days ,this will assess both intra-rater and inter-rater reliability. Validity will be examined through face, content, and construct validity,. 
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