| CTRI Number |
CTRI/2025/05/086725 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
09/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the Link Between Fear of Movement, Knee Alignment, and Osteoarthritis Severity in Individuals with Knee Pain |
|
Scientific Title of Study
|
ASSOCIATION BETWEEN KINESIOPHOBIA, DYNAMIC KNEE VALGUS AND GRADES OF OSTEOARTHRITIS IN INDIVIDUALS WITH KNEE OSTEOARTHRITIS |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidushi Singh |
| Designation |
Physiotherapist |
| Affiliation |
Manav Rachna international institute of research and studies |
| Address |
Block QS 11 Department of Physiotherapy Manav Rachna International Institute of Research and Studies Sector 43 Surajkund Road, Faridabad, haryana
Faridabad
HARYANA
121004
India |
| Phone |
9971148446 |
| Fax |
|
| Email |
vidushisunita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vidushi Singh |
| Designation |
Physiotherapist |
| Affiliation |
Manav Rachna international institute of research and studies |
| Address |
Block QS 11 Department of Physiotherapy Manav Rachna International Institute of Research and Studies Sector 43 Surajkund Road, Faridabad, haryana
Faridabad
HARYANA
121004
India |
| Phone |
9971148446 |
| Fax |
|
| Email |
vidushisunita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr kshitija bansal |
| Designation |
Professor |
| Affiliation |
Manav Rachna international institute of research and studies |
| Address |
Block QS 06 Department of Physiotherapy Manav Rachna International Institute of Research and Studies Sector 43 Surajkund Road, Faridabad, haryana
Faridabad
HARYANA
121004
India |
| Phone |
919810314488 |
| Fax |
|
| Email |
kshitijabansal.sahs@mriu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manav rachna institute of research and studies |
| Address |
Q Block Department of Physiotherapy Manav Rachna International Institute of Research and Studies Sector 43 Suraj Kund Road, Faridabad |
| Type of Sponsor |
Other [university ] |
|
|
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 kshitija bansal |
Manav Rachna international institute of research and studies |
QS 11 Q block Department of Physiotherapy Manav Rachna International Institute of Research and Studies Sector 43 Surajkund Road, Faridabad, haryana
Faridabad
HARYANA |
9810314488
kshitijabansal.sahs@mriu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethical commitee manav rachna internatinal institute of research and studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age between 40 60 years old
Understands English
Clinical Diagnosis of knee osteoarthritis
Unilateral osteoarthritis
BMI 29.9 or less |
|
| ExclusionCriteria |
| Details |
History of knee surgery or knee replacement
Neurological conditions (affecting lower limb function)
Recent injuries
Uncontrolled diabetes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Frontal Plane Projection Angle
Kellgren-Lawrence Scale
Grades of Osteoarthritis |
one time study at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| dynamic knee valgus measured with & without footwear |
one time study at baseline |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
26/05/2025 |
| 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="6"
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
|
The research will involve 84 participants with unilateral knee osteoarthritis, aged 40–60. After obtaining consent, participants will complete the Tampa Scale for Kinesiophobia and have their osteoarthritis severity graded using X-rays and the Kellgren-Lawrence scale. Dynamic knee valgus will be assessed during a single-leg step-down task using video analysis (Kinovea software), both barefoot and with footwear. Measurements will include Frontal plane projection angle The data will then be analyzed to identify correlations between kinesiophobia, knee valgus, and OA grades. |