| 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
|
|
|
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
|
|
|
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. |