FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/074052 [Registered on: 19/09/2024] Trial Registered Prospectively
Last Modified On: 18/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparing joint position sense in the normal knee of patient with one sided knee osteoarthritis (knee pain due to ageing) with healthy individual of same age and gender. 
Scientific Title of Study   Comparison of proprioception in the unaffected knee of patient with unilateral knee osteoarthritis with healthy age and gender matched individual - An Observational Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bharati Asgaonkar 
Designation  Associate Professor (PT) 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital  
Address  Room No. 2, OPD-24 (M building) Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400008
India 
Phone  8369973303  
Fax    
Email  bharatida1234@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bharati Asgaonkar 
Designation  Associate Professor (PT) 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital  
Address  Room No. 2, OPD-24 (M building) Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400008
India 
Phone  8369973303  
Fax    
Email  bharatida1234@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sanket Sangale  
Designation  Post Graduate Student (Physiotherapist) 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
Address  Room No. 2, OPD-24 (M building) Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400008
India 
Phone  9594080408  
Fax    
Email  sanketsangle121ss@gmail.com  
 
Source of Monetary or Material Support  
P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Mumbai 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [[]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bharati Asgaonkar  P.T School & Centre, T.N.M.C & B.Y.L Ch Nair Hospital  Room No. 2, OPD-24 (M building) Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai
Mumbai (Suburban)
MAHARASHTRA 		 8369973303

bharatida1234@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Academic Research Projects (ECARP) PG Academic Committee T.N. Medical College and B.Y.L Nair Ch Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Individuals in the age group of 40-60 years.
2. Male and female patient with a chronic knee OA.
3. Kellgren-Lawrence grades 1-3 on knee radiograph.
4. Willing to participate. 
 
ExclusionCriteria 
Details  1. Knee surgery within last 12 months.
2. Any neuromuscular or vascular disorder of lower limb.
3. Diabetes Mellitus.
4. Deformity of hip, ankle, back, knee or either knee trauma during last 3 months.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proprioception (joint position sense error)

Difference between actual leg position and target leg position. 

6 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   10/10/2024 
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 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   NEED OF STUDY
The Physiotherapy OPD receives many patients with knee osteoarthritis, it is most common condition that diminishes mobility and induces pain. Despite the prevalence of knee OA, there is a noticeable gap in our understanding of how it specifically influences proprioception – the body’s ability to sense and control movement. This study aims to explore the proprioceptive aspects of the unaffected knee in patient with unilateral knee OA compared to those without knee pain. Knee OA is known to alter joint mechanics and impact daily activities, but its precise effect on proprioception, especially in the unaffected leg, remain unclear. Proprioception is vital for coordinating movements and maintaining balance, making it crucial to investigate whether knee OA extends its influence beyond the directly affected joint. Existing research primarily focuses on proprioception in the affected leg or general functional limitations in knee OA. However, studies specifically exploring proprioceptive changes in the unaffected leg are limited. This study will contribute by building upon the existing literature and providing a more comprehensive understanding of proprioceptive alterations in knee OA. Understanding proprioception in the unaffected leg is essential for several reasons. First, it can shed light on whether knee OA has a systemic impact on proprioceptive abilities. Second, identifying specific proprioceptive changes may offer insights into how the body compensates for the affected knee. Lastly, this knowledge could have direct implications for designing targeted rehabilitation programs that not only address the affected joint but also consider the overall proprioceptive function.

AIM
To Compare the Proprioception in Unaffected Knee of Patient with Unilateral Knee Osteoarthritis with healthy age and gender matched individual. 

OBJECTIVES
1) To assess proprioception in affected knee of patient with unilateral knee OA. 

2) To assess proprioception in unaffected knee of patient with unilateral knee OA.

3) To assess proprioception in knee of healthy individual (without knee pain).

4) To compare proprioception in affected knee of patient with knee OA with unaffected knee and with healthy individual.

PROCEDURE

• Study will be conducted in the physiotherapy OPD of tertiary care hospital. The study will begin after approval from Departmental Review Board and Institutional Ethics Committee (IEC).
• Patients and controls will be selected according to the inclusion criteria and a written consent will be obtained. 
• Control subjects would be patient relatives or patients who do not have knee OA (Whose knee x-rays are negative for knee OA).The cost of x-ray will be borne by me. 
• Once consent is obtained, ICD will be signed, retained by the principal investigator and a copy of ICD will be given to the participant.
• Each participant will participate in a single testing session and will be given a information sheet to know the details of the study.
• The case record form which includes demographic data and details will be obtained and filled. The process is explained below. Data will be obtained from the subjects within the age group of 40-60 years seen during their first evaluation of knee pain at our OPD of tertiary care hospital.
• Study design will be observational study. 
• Proprioception assessment will be done in non-weightbearing position (i.e.in high sitting).
• With the help of Universal Goniometer.
• Subject will be made sit with legs out of the plinth and thigh fully supported.
• To obtain proper readings of knee angle, the goniometer will be tie to the leg with the help of Velcro straps.
• Fulcrum of the goniometer will be placed on lateral knee joint line, stationary arm will be parallel to line joining greater trochanter to fulcrum and movable arm will be place parallel to line joining fulcrum and  lateral malleolus.
• Then leg will be place at three different angles (30º,45º,60º) very slowly and hold for 5 seconds at each angle to identify the position and will ask them to remember the target positions.
• Then returns to starting position, passively.
• After that subject will be blindfolded to avoid visual cues.
• Then subject will be asked to place leg at varies angle randomly, which was shown earlier, at every angle three readings will be taken.
• For every reading the difference between actual leg position and target position angle will be recorded.
• Mean of the readings will be calculated and recorded as patient’s joint position error (JPE).
• First reading will be taken from affected leg then from unaffected leg and finally it will be taken from control groups individuals. 
• Comparison between affected and unaffected, unaffected and control group individuals will be done. 
• Data will be collected and subjected to normality test. If the test passes the normality value parametric test will be done and if not pass then non parametric test will be done.

DATA MANAGEMRNT AND ANALYSIS PROCEDURE: 
All the data obtained from the participants will be kept confidential. Both hard and soft copy will be maintained. The data will be stored in excel sheets for analysis. Data will be checked for normality, for normally distributed data parametric test will be used. When patient’s affected knee compares with unaffected knee for joint position sense error (JPS), then Paired t-Test will be used.
When unaffected knee of patient compares with knee of normal individual for joint position sense error (JPS), then Unpaired t-Test will be used. 
If data does not pass normality test, then non-parametric test such as Mann-Whitney U Test or Wilcoxon signed rank test will be used. SPSS software will be used for analysis.




 
Close