| CTRI Number |
CTRI/2026/01/100929 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
test retest reliability and validation study |
| Study Design |
Other |
|
Public Title of Study
|
Development of a Kannada Ankle Assessment Tool to Identify and Predict Ankle Instability |
|
Scientific Title of Study
|
Translation, Validation, and Machine Learning-Based Predictive Modeling of the Kannada Version of the Cumberland Ankle Instability Tool (CAIT-K) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chithra |
| Designation |
PG Student |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Musculoskeletal sciences and sports physiotherapy department,
Institute of Physiotherapy,
Srinivas University,
Pandeshwar,
Dakshina Kannada,
Managalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7899495330 |
| Fax |
|
| Email |
chithuacharya2410@gmail,com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayakumar Palaniswamy |
| Designation |
Professor |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Musculoskeletal sciences and sports physiotherapy department,
Institute of Physiotherapy,
Srinivas University,
Pandeshwar,
Dakshina Kannada,
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8148745409 |
| Fax |
|
| Email |
vijayakumarpalaniswamy.ipt@srinivasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Chithra |
| Designation |
PG Student |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Musculoskeletal sciences and sports physiotherapy department,
Institute of Physiotherapy,
Srinivas University,
Pandeshwar,
Dakshina Kannada,
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7899495330 |
| Fax |
|
| Email |
chithuacharya2410@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
CHITHRA |
| Address |
Musculoskeletal sciences and sports physiotherapy department,
Institute of Physiotherapy,
Srinivas University,
Pandeshwar,
Dakshina Kannada,
Mangalore,
575001 |
| 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 |
| Dr Chithra |
Institute of Physiotherapy, Srinivas University |
Musculoskeletal sciences and sports physiotherapy department,
Institute of
Physiotherapy,
Srinivas University,
City campus- ground floor,
Pandeshwar,
Dakshina Kannada,
Mangalore
Dakshina Kannada
KARNATAKA |
07899495330
chithuacharya2410@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD AND ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M242||Disorder of ligament, |
|
|
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 |
Experienced at least one major ankle sprain
Age more than 18 years
Participants able to read and write Kannada
Both Males and Females
Experienced episodes of ankle instability or giving way. |
|
| ExclusionCriteria |
| Details |
Previous surgical procedures or ankle fracture
Ankle injuries less than 3months prior to the study
Central or neurological signs like paraesthesia, numbness
Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CUMBERLAND ANKLE INSTABILITY TOOL (CAIT-K) |
at baseline and 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
24/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/01/2026 |
| 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
|
PURPOSE OF THE STUDY To translate, culturally adapt, and validate the CAIT K,establish its reliability and known-group validity, and apply machine learning models to determine an optimized cut-off score for diagnosing CAI.
Null Hypothesis The CAIT K will not demonstrate good test-retest reliability, known groups validity, or predictive accuracy for CAI diagnosis.
Alternative Hypothesis The CAIT K will demonstrate good test-retest reliability, known groups validity, and predictive accuracy for CAI diagnosis. |