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CTRI Number  CTRI/2025/07/092007 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Testing the Reliability of Pressure Biofeedback for Measuring Gastrocnemius Muscle Activity in Adults with Knee Osteoarthritis 
Scientific Title of Study   Establishing Test-Retest Reliability of Pressure Biofeedback in Measuring Gastrocnemius Muscle Activation in Adults with Bilateral 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  Yashasvi Parmar 
Designation  MPT Student 
Affiliation  MMIPR, Maharishi Markandeshwar (Deemed to be University) 
Address  First Floor, Physiotherapy Department, MMIPR, Maharishi Markandeshwar (Deemed to be University), Mullana

Ambala
HARYANA
133207
India 
Phone  8427357220  
Fax    
Email  yashasvi22parmar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sunita Sharma  
Designation  Professor 
Affiliation  MMIPR, Maharishi Markandeshwar (Deemed to be University) 
Address  First Floor, Physiotherapy Department, MMIPR, Maharishi Markandeshwar (Deemed to be University), Mullana

Ambala
HARYANA
133207
India 
Phone  9467633734  
Fax    
Email  drsunita.sharma@mmumullana.org  
 
Details of Contact Person
Public Query
 
Name  Dr Sunita Sharma  
Designation  Professor 
Affiliation  MMIPR, Maharishi Markandeshwar (Deemed to be University) 
Address  First Floor, Physiotherapy Department, MMIPR, Maharishi Markandeshwar (Deemed to be University), Mullana

Ambala
HARYANA
133207
India 
Phone  9467633734  
Fax    
Email  drsunita.sharma@mmumullana.org  
 
Source of Monetary or Material Support  
Orthopedic Physiotherapy Research Laboratory, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana, 133207 
 
Primary Sponsor  
Name  Yashasvi Parmar 
Address  First Floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana, 133207 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Sunita Sharmar  First Floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana, 133207 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Yashasvi Parmar  MMIPR Physiotherapy OPD  First Floor, Physiotherapy Department, MMIPR, Maharishi Markandeshwar (Deemed to be University), Mullana
Ambala
HARYANA 
8427357220

yashasvi22parmar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee, Maharishi Markandeshwar Institute of Medical Science and Research, Mullana-Ambala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M172||Bilateral post-traumatic osteoarthritis of knee, (2) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (3) ICD-10 Condition: M174||Other bilateral secondary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age more than 50-80 years
2. Both male and female
3. Knee OA Grade I, II, and III based on the Kellgren and Lawrence grading system
4. A patient who can follow simple verbal commands
 
 
ExclusionCriteria 
Details  1. Knee Osteoarthritis Grade IV based on the Kellgren and Lawrence grading system
2. Injuries surrounding the gastrocnemius muscle
3. Any recent injury or surgery
4. History of neurological conditions
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pressure Biofeedback Unit  Baseline and 48 hours later (i.e. 2 days later) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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)   11/08/2025 
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)   Open to Recruitment 
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 a prevalent degenerative joint disorder that commonly affects the knee joint, leading to pain, stiffness, and functional limitations in adults. Among the muscles involved in knee function, the gastrocnemius plays a crucial role in knee flexion and ankle plantarflexion, contributing significantly to mobility and balance. Hence, the accurate measurement of gastrocnemius muscle activation is essential for understanding its role in managing OA symptoms and developing targeted rehabilitation interventions. Pressure biofeedback devices, traditionally used for muscle activation, offer a non-invasive method to measure muscle activity during specific tasks or exercises. In OA patients, the variability in muscle function due to pain, inflammation, and compensatory patterns makes using a tool that provides dependable and repeatable results crucial. However, for the pressure biofeedback tool to be a reliable measure of gastrocnemius muscle activation in symptomatic OA adults, its test-retest reliability must be established. This research aims to study the test-retest reliability of the pressure biofeedback unit in measuring gastrocnemius muscle activation while performing the isometric gastrocnemius contraction in long sitting. It is a single-group Cross-Sectional Study. Participants will be recruited based on inclusion and exclusion criteria. The participants will complete the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scale to assess the baseline severity of their symptoms, including pain, stiffness, and functional limitations. Following this, they will perform gastrocnemius contraction in a long sitting position under the supervision of a trained physiotherapist. Baseline data on gastrocnemius muscle activation will be collected using a pressure biofeedback unit to measure changes in pressure as an indicator of muscle activation. Participants will then return 48 hours later to perform the gastrocnemius contraction in long sitting again under the same conditions, and the measurements will be repeated to evaluate the test-retest reliability of the device. Efforts will be made to maintain consistency across both sessions by providing standardized instructions and using the same equipment setup.

 
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