| CTRI Number |
CTRI/2025/07/091967 [Registered on: 29/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship Between Joint Position Sense, Functional Task Performance, and Patient-Reported Outcomes in Knee Osteoarthritis |
|
Scientific Title of Study
|
Correlation of Proprioception with Task-Oriented Performance and Self Reported Measure in 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 |
Bibhujit Mishra |
| Designation |
MPT Student |
| Affiliation |
Maharishi Markandeshwar Institute Of Physiotherapy And Rehabilitation |
| Address |
Ground floor,Department of Physiotherapy And Rehabilitation, Maharishi Markandeshwar (Deemed to be University)
Ambala
HARYANA
133207
India |
| Phone |
7789802980 |
| Fax |
|
| Email |
zeethundred@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amita Aggarwal |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute Of Physiotherapy And Rehabilitation |
| Address |
Ist floor,Department of Physiotherapy And Rehabilitation, Maharishi Markandeshwar (Deemed to be University)
Ambala
HARYANA
133207
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bibhujit Mishra |
| Designation |
MPT sudent |
| Affiliation |
MAHARSHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABLITATION |
| Address |
Ground floor,Department of Physiotherapy And Rehabilitation, Maharishi Markandeshwar (Deemed to be University)
Ambala
HARYANA
133207
India |
| Phone |
7789802980 |
| Fax |
|
| Email |
zeethundred@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation,Maharishi Markandeshwar (Deemed to be University) Mullana-Ambala,Haryana, 133207 |
|
|
Primary Sponsor
|
| Name |
Bibhujit Mishra |
| Address |
Ground floor,Maharishi Markandeshwar Institute Of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University) Mullana-Ambala, Haryana, 133207. |
| 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 Bibhujit Mishra |
Maharishi Markandeshwar Institute of Physiotherapy And Rehabilitation |
Room No.2, Ground floor, Department of Physiotherapy, Maharishi Markandeshwar (Deemed to be University), Mullana
Ambala
HARYANA |
7789802980
zeethundred@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee, Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana-Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 40 and 60 years
2. Both males and females will be included
3. Based on the X-ray findings
(KL Grading scale grade II or less)
4. B/L knee OA cases
|
|
| ExclusionCriteria |
| Details |
1. Patient with Grade III and IV OA Knee
2. Patients with history of knee fracture.
3. Steroid injections in past 2 months
4. Patients with neuromuscular disorder
5. Patients with history of vertigo (vertigo dysfunction)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. 9-step Stair-climbing test (9s-SCT)
2. Time up and go test (TUG)
3. 30 second chair-stand test (30sCST)
4. 40-m fast walking- test (40MFPW)
5. 6-Minute walking test (6MWT)
6. KOOS questionnaire
7. Proprioception |
At baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
01/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Osteoarthritis (OA) is the most common type of arthritis, causing joint cartilage and bone deterioration, leading to stiffness and impaired movement and also affect proprioceptive. The Osteoarthritis Research Society International (OARSI) emphasizes the importance of performance-based physical function tests for evaluating outcome in individuals with hip or knee OA. To find the correlation of proprioception with task-oriented performance and self-reported measures in knee osteoarthritis. After the ethical committee approval, based on inclusion and exclusion criteria correlation study will be performed on knee OA patients. Subjects will be evaluated for 5 task-oriented performance followed by self-reported scale using OARSI and KOOS scales. Then the proprioception will be recorded by using Sensamove. |