| CTRI Number |
CTRI/2025/06/088629 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| 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 and Ankle outcome Score (FAOS) Scale in individuals with ankle and foot problems |
|
Scientific Title of Study
|
Translation, cross-cultural adaptation and validation of Foot and Ankle Outcome Score -Kannada version for individuals with ankle and 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 |
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
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 |
Outpatient Department, Alvas Health Centre, AHC complex, AHC road, Moodbidri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9591593863 |
| Fax |
|
| Email |
poonjakshama@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Alvas College of Physiotherapy and Research Centre |
| Address |
Outpatient Department, Alvas Health Centre, AHC complex, AHC road, Moodbidri |
| 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 |
| Hariharasudhan Ravichandran |
Alvas Health Centre |
Outpatient Department, Department of Physiotherapy, Alvas College of Physiotherapy and Research Centre, AHC complex, AHC road, Moodbidri
Dakshina Kannada
KARNATAKA |
9789906015
hrkums63@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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: M259||Joint disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with foot and ankle dysfunctions diagnosed by a physician, traumatic and non-traumatic pathologies included, chronic conditions |
|
| ExclusionCriteria |
| Details |
Neurological or other systemic disorders, congenital deformities or conditions, individuals with cognitive dysfunctions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Validity,
Reliability |
Baseline to 4 weeks for test retest reliability |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="205"
Sample Size from India="205"
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="2"
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, validation of Ankle and Foot Outcome Score will assist to assess the outcomes of foot and ankle disorders from Kannada speaking patients globally. The validated questionnaire helps to collect accurate information regarding the Kannada speaking patients foot and ankle problems in their well known language. Translation into kannada language helps to compare the psychometric properties of this translated questionnaire among indian languages and other international languages. |