FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/100387 [Registered on: 06/01/2026] Trial Registered Prospectively
Last Modified On: 06/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Longitudinal study 
Study Design  Other 
Public Title of Study   Kannada translation of LEFS scale  
Scientific Title of Study   Translation cross cultural adaptation reliability and validity of lower extremity functional scale: Kannada version 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anju Thomas  
Designation  Post graduate student  
Affiliation  Yenepoya Physiotherapy College  
Address  Yenepoya physiotherapy college, Physiotherapy department,7th floor, University Road Deralakatte, Mangalore Karnataka India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448981884  
Fax    
Email  36817@yenepoya.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Mr. R Sathyaraja  
Designation  Assistant Professor  
Affiliation  Yenepoya Physiotherapy College  
Address  Yenepoya physiotherapy college, Physiotherapy department,7th floor, University Road Deralakatte, Mangalore Karnataka India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9150908049  
Fax    
Email  rsathyaraja@yenepoya.edu.in  
 
Details of Contact Person
Public Query
 
Name  Mr. R Sathyaraja 
Designation  Assistant professor  
Affiliation  Yenepoya Physiotherapy College  
Address  Yenepoya physiotherapy college, Physiotherapy department,7th floor, University Road Deralakatte, Mangalore Karnataka India-575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9150908049  
Fax    
Email  rsathyaraja@yenepoya.edu.in  
 
Source of Monetary or Material Support  
Yenepoya physiotherapy college, Physiotherapy department,7th floor, University Road Deralakatte, Mangalore Karnataka India- 575018 
 
Primary Sponsor  
Name  Anju Thomas  
Address  Yenepoya physiotherapy college, Physiotherapy department,7th floor, University Road Deralakatte, Mangalore Karnataka India-575018 
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 
Anju Thomas  Yenepoya Medical College Hospital  Physiotherapy department,7th floor, University Road Deralakatte, Mangalore Karnataka India-575018
Dakshina Kannada
KARNATAKA 
9448981884

36817@yenepoya.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya Ethics Committee 3  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patient age group above 18 years
2. Patients with any lower limb musculoskeletal conditions.
3. Patients who know to read, write and speak Kannada 
 
ExclusionCriteria 
Details  1. Uncooperative patients
2. Patient with serious medical conditions such as Spinal cord injuries, Visual
impairment, Advanced diabetes mellitus, Severe heart failure, Stroke and any
neurological conditions.
3. Patients who are not a native speaker (Kannada) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
lower extremity functional scale   baseline  
 
Secondary Outcome  
Outcome  TimePoints 
nil   nil 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   17/01/2026 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Lower extremity functional scale (LEFS) is a validated patient-reported outcome measure designed to assess functional impairments and disabilities related to the lower extremities. The scale, which consists of 20 items that assess walking, stair climbing, and everyday functioning tasks, is frequently used in clinical and research settings to track patient progress and assess therapy results. The lack of a validated Kannada version limits its utility among Kannada-speaking populations, despite its global applicability. This prevents accurate evaluation and effective therapeutic approaches.

However, no Kannada adaptation of the LEFS scale is available. Translating the LEFS into Kannada, following Beaton’s guidelines for cross-cultural adaptation, ensures that Kannada-speaking patients can accurately understand and respond, improving the accessibility and reliability of the tool. A sample size of 37 participants is being utilized to ensure cultural and linguistic relevance. 

The purpose of this study is to assess the test-retest reliability and content validity of the Lower Extremity Functional Scale (LEFS) and translate it into Kannada. Patients will gain from the translation by being able to communicate functional difficulties, researchers will gain from having a trustworthy tool for Kannada-speaking communities, and medical practitioners will gain from having correct data for individualized care. This culturally sensitive approach will improve patient treatment, research, and communication.

 
Close