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CTRI Number  CTRI/2025/06/088084 [Registered on: 02/06/2025] Trial Registered Prospectively
Last Modified On: 26/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparing electrical activity of two thigh muscles, during Sit-to-Stand and Stand-to-Sit in persons with and without knee osteoarthritis. 
Scientific Title of Study   Comparative study of temporal activation and activity of Vastus medialis oblique and Vastus lateralis muscle using Surface Electromyography in individuals with knee osteoarthritis and asymptomatic individuals during Sit-to-Stand and Stand-to-Sit. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kashish Jaiswal 
Designation  Postgraduate Student- MPT 
Affiliation  All India Institute of Physical Medicine and Rehabilitation Mumbai 
Address  Physiotherapy Department, room no: 210 2nd floor, All India Institute of Physical Medicine and Rehabilitation, KK Marg, Haji Ali, Mahalaxmi, Mumbai

Mumbai
MAHARASHTRA
400034
India 
Phone  7039753455  
Fax    
Email  kashishjaiswal19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vaibhav Dolas 
Designation  Lecturer, Physiotherapy 
Affiliation  All India Institute of Physical Medicine and Rehabilitation Mumbai 
Address  Physiotherapy department, Room no:210, 2nd floor, All India Institute of Physical Medicine and Rehabilitation, KK Marg, Haji Ali, Mahalaxmi, Mumbai

Mumbai
MAHARASHTRA
400034
India 
Phone  9820384812  
Fax    
Email  vsdolas21@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vaibhav Dolas 
Designation  Lecturer, Physiotherapy 
Affiliation  All India Institute of Physical Medicine and Rehabilitation Mumbai 
Address  Physiotherapy Department, Room no:210, 2nd floor, All India Institute of Physical Medicine and Rehabilitation, KK Marg, Haji Ali, Mahalaxmi, Mumbai

Mumbai
MAHARASHTRA
400034
India 
Phone  9820384812  
Fax    
Email  vsdolas21@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Physical Medicine and Rehabilitation, Mahalaxmi, Mumbai-400034 
 
Primary Sponsor  
Name  Kashish Jaiswal 
Address  Physiotherapy Department, AIIPMR, Mahalaxmi, Mumbai-400034 
Type of Sponsor  Other [Self] 
 
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 Kashish Jaiswal  Physiotherapy dept., AIIPMR Mumbai  Room no: 210, Physiotherapy dept., AIIPMR, Mahalaxmi, Mumbai:400034
Mumbai
MAHARASHTRA 		 7039753455

kashishjaiswal19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIPMR, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Inclusion Criteria of the Knee Osteoarthritis Group:
1.Age 50-70 years
2.Pain 1-3 in Numerical pain Rating scale
3.Stable intake of non-steroidal anti-inflammatory drugs over the previous fortnight.
4.All genders
5.Unilateral symptomatic knee osteoarthritis- Grade II to III
a.Diagnosed according to the American College of Rheumatology classification
b.Diagnosed from OPD by Kellgren and Lawerence classification system of radiological classification.
Inclusion Criteria of the Asymptomatic Group:
1.Age 50-70 years
2.All genders
3.No complaints of knee pain in bilateral knees


 
 
ExclusionCriteria 
Details  Exclusion Criteria for knee osteoarthritis group:
1. Physiotherapy treatment for the knee (previous 12 months)
2. Any Previous surgical intervention of the knee
3.Intra-articular steroid injection (previous 6 months)
4.Systemic arthritic condition
5.Any medical condition affecting the performance
6.Significant cognitive, cardiorespiratory, and neurological impairments that will affect performance
Exclusion Criteria for the Asymptomatic Group:
1. Any joint disorder, or injury in either knee in the past year (for which treatment was sought, or which interfered with function)
2. Abnormal findings on physical examination of the knee (flexion range of motion 125°, swelling, palpable warmth, ligamentous laxity).
3. Significant cognitive, cardiorespiratory, and neurological impairments that will affect participation.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Onset Activation Time(msec)
2.Amplitude of sEMG activity(µV)
3.Maximum Isometric Strength (kgs)
 		 Baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/06/2025 
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   Title: Comparative study of temporal activation and activity of Vastus medialis oblique and Vastus lateralis muscle using Surface Electromyography in individuals with knee osteoarthritis and asymptomatic individuals during Sit-to-Stand and Stand-to-Sit.

Aim: To assess the Temporal activation and activity of vastus medialis oblique and vastus lateralis muscle using surface electromyography during sit-to-stand and stand-to-sit in individuals with knee osteoarthritis and asymptomatic individuals.
Objective: Primary Objective:

1.     To Evaluate the onset activation time and electromyographic activity of VMO and VL using Surface EMG in individuals with knee osteoarthritis and asymptomatic individuals during sit-to-stand and stand-to-sit.

To compare the onset activation time and electromyographic activity of vastus medialis oblique and vastus lateralis muscle in individuals with knee osteoarthritis and asymptomatic individuals during sit-to-stand and stand-to-sit.
Other Objective: To Find the relationship between Electromyographic activity and the isometric strength of quadriceps muscle in individuals with knee osteoarthritis, and asymptomatic individuals during sit-to-stand and stand-to-sit.
 
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