| CTRI Number |
CTRI/2025/06/089332 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
21/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Translating Lower Limb Functional Scale into Kannada language for Kannada speaking patients |
|
Scientific Title of Study
|
Translation, Cross-cultural adaptation and Validation of Lower Limb Functional Index - Kannada version for individuals with lower limb dysfunctions |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hariharasudhan Ravichandran |
| Designation |
Professor |
| Affiliation |
Alvas College of Physiotherapy and Research Centre |
| Address |
Outpatient department, Alvas Health Centre, AHC complex, AHC road, Moodbidri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9789906015 |
| Fax |
|
| Email |
hrkums63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hariharasudhan Ravichandran |
| Designation |
Professor |
| Affiliation |
Alvas College of Physiotherapy and Research Centre |
| Address |
Outpatient department, Alvas Health Centre, AHC complex, AHC road, Moodbidri
KARNATAKA
574227
India |
| Phone |
9789906015 |
| Fax |
|
| Email |
hrkums63@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kshama Susheel Shetty |
| Designation |
Professor |
| Affiliation |
Alvas College of Physiotherapy and Research Centre |
| Address |
Alvas College of Physiotherapy and Research Centre
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9591593863 |
| Fax |
|
| Email |
poonjakshama@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas College of Physiotherapy and Research Centre, Ground floor, OP Department, Department of Physiotherapy, Physiotherapy Block, AHC Complex, AHCroad, Moodbidri, DK, Karnataka - 574227, India |
|
|
Primary Sponsor
|
| Name |
Alvas College of Physiotherapy and Research Centre |
| Address |
Alvas Health Centre Complex, AHC road, Moodbidri, Dakshina Kannada, Karnataka - 574227 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Hariharasudhan Ravichandran |
OPD, Department of Physiotherapy, Alvas College of Physiotherapy and Research Centre |
Alvas Health Centre Complex, AHC road, Moodbidri, Dakshina Kannada, Karnataka - 574227
Dakshina Kannada
KARNATAKA |
9789906015
hrkums63@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Alvas College of Physiotherapy and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M799||Soft tissue disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with lower limb soft tissue injuries, requiring immobilization, conditions requiring physiotherapy rehabilitation for atleast 6 weeks |
|
| ExclusionCriteria |
| Details |
Systemic disorders, neurological conditions, individuals with concomitant upper limb injuries or injuries in other parts of body or bilateral lower limb injuries, individuals with cognitive dysfunctions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Translation, Validity and Reliability |
Baseline and 4 weeks (test re-test reliability) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="185"
Sample Size from India="185"
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)
|
07/07/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Translation and linguistic validation of Lower Limb Functional Index scale into Kannada language could provide the comparison for validation with other translated versions and also could benefit in identifying outcomes in patients with lower limb injuries from rural areas. |