| CTRI Number |
CTRI/2025/06/088949 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
05/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Validating Kannada version of Foot Function Index among patients with Foot problems |
|
Scientific Title of Study
|
Translation, cross-cultural adaptation and validation of Foot Function Index - Kannada version for individuals with foot 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 |
Department of Physiotherapy, Alvas Health Centre complex, AHC road, Moodbidri, Dakshina Kannada, Karnataka, India
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 |
Department of Physiotherapy, Alvas Health Centre complex, AHC road, Moodbidri, Dakshina Kannada, Karnataka, India
Dakshina Kannada
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 |
Department of Physiotherapy, Alvas Health Centre complex, AHC road, Moodbidri, Dakshina Kannada, Karnataka, India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9591593863 |
| Fax |
|
| Email |
poonjakshama@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nil: There is no monetory benefit for this research |
|
|
Primary Sponsor
|
| Name |
Alvas College of Physiotherapy and Research Centre |
| Address |
Department of Physiotherapy, Alvas Health Centre complex, AHC road, Moodbidri, Dakshina Kannada, Karnataka, India |
| 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 |
| Kshama Susheel Shetty |
Alvas College of Physiotherapy and Research Centre |
Department of Physiotherapy, Alvas Health Centre complex, AHC road, Moodbidri, Dakshina Kannada, Karnataka, India
Dakshina Kannada
KARNATAKA |
9591593863
poonjakshama@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: S999||Unspecified injury of ankle and foot, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Language proficiency: Participants should be native Karnataka speakers or individuals fluent in Hindi, as they will be required to understand and respond to the translated FFI questionnaire.
Both genders, aged 18 to 60 years with Foot-related condition. Participants should have received a clinical diagnosis of the foot-related condition by a qualified healthcare professional. Willingness to participate |
|
| ExclusionCriteria |
| Details |
Inability to understand or communicate in kannada. Participants who do not have sufficient proficiency in Kannada to understand the
translated FFI questionnaire or provide meaningful responses should be excluded. Individuals with severe cognitive impairment or neurological conditions that impair their ability to comprehend and respond to the questionnaire accurately may be excluded. Individuals who have medical
conditions or physical limitations that prevent them from completing the FFI questionnaire or participating in the study procedures safely.
Participation in a similar study. Inability to provide informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Content validity
Concurrent validity
Test retest reliability
|
Baseline and 3 weeks for test retest reliability |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of motion |
Baseline to 48 hours |
|
|
Target Sample Size
|
Total Sample Size="379"
Sample Size from India="379"
Final Enrollment numbers achieved (Total)= "379"
Final Enrollment numbers achieved (India)="379" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/06/2025 |
| Date of Study Completion (India) |
30/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/09/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
The primary objective of this study is to translate the FFI into Kannada version, the native
language of a significant population in India, and evaluate its cross-cultual adaptation and validity and reliability in the Kannada speaking-speaking population. |