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CTRI Number  CTRI/2025/10/095895 [Registered on: 10/10/2025] Trial Registered Prospectively
Last Modified On: 10/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparison of Muscle Recruitment patterns in healthy individuals end stage osteoarthritis and in Total Knee Replacement patients 
Scientific Title of Study   Comparative Analysis of Muscle Recruitment patterns in healthy individuals end stage osteoarthritis and Total Knee Replacement patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manasi Dhanawade 
Designation  Post Graduate 
Affiliation  Kasturba Medical College, Mangalore, MAHE 
Address  Department of Physiotherapy, Centre for Basic Sciences, Bejai, Kasturba Medical College, Mangalore- 575004 Dakshina Kannada Karnataka 575004 India

Dakshina Kannada
KARNATAKA
575004
India 
Phone  7875362049  
Fax    
Email  manasi.mchpmlr2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Manasi Dhanawade 
Designation  Post Graduate 
Affiliation  Kasturba Medical College, Mangalore, MAHE 
Address  Department of Physiotherapy, Centre for Basic Sciences, Bejai, Kasturba Medical College, Mangalore- 575004 Dakshina Kannada Karnataka 575004 India

Dakshina Kannada
KARNATAKA
575004
India 
Phone  7875362049  
Fax    
Email  manasi.mchpmlr2024@learner.manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Ashish John Prabhakar 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Mangalore, MAHE 
Address  Department of Physiotherapy, Centre for Basic Sciences, Bejai, Kasturba Medical College, Mangalore- 575004 Dakshina Kannada Karnataka 575004 India

Dakshina Kannada
KARNATAKA
575004
India 
Phone  8123223092  
Fax    
Email  ashish.john@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Mangalore, MAHE, Dakshina Kannada, Karnataka- 575001, India 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Ashish John Prabhkar  Kasturba Medical College Hospital Jyothi and Attavar  Department of Physiotherapy, Fifth floor, Umbedkar Circle, Mangalore 575002
Dakshina Kannada
KARNATAKA 		 8123223092

ashish.john@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical College, Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individuals 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Healthy individuals
Non symptomatic individuals for knee pain
Healthy individuals 45 to 75 years age and gender matched
Both genders

Patients with Knee OA
Diagnosed cases of knee osteoarthritis by an orthopaedic or rheumatologist x ray findings of more than grade 3 according to Kellgren Lawwrence grading
Both genders

Patients who have undergone Total Knee Replacement surgery
Patients who have undergone primary unilateral Total Knee Replacement surgery and are hemodynamically stable
TKR patients with post operative day 5 
 
ExclusionCriteria 
Details  Presence of neurological conditions affecting motor control
Musculoskeletal disorders or injuries in the past 3 months
Lower limb fractures or surgeries other than TKR
Cognitive impairment affecting the ability to follow instructions 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Electromyography  All assessments will be performed at a single time point for each participant group which are healthy individuals end-stage knee osteoarthritis and post total knee replacement 
 
Secondary Outcome  
Outcome  TimePoints 
Sensor based goniometer  All assessments will be performed at a single time point for each participant group which are healthy individuals end stage knee osteoarthritis & post total knee replacement 
Isometric strength test  All assessments will be performed at a single time point for each participant group which are healthy individuals end stage knee osteoarthritis & post total knee replacement 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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)   10/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/11/2025 
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   The study title is Comparative analysis of muscle recruitment patterns in healthy individuals end stage osteoarthritis and total knee replacement patients. The study aims to compare muscle recruitment patterns, among healthy individuals and end stage osteoarthritis and total knee replacement .  The outcomes measures will be electromyography to assess muscle recruitment patterns and to assess knee joint range of motion flexion extension angles and velocity between the groups using sensor based goniometer and to measure muscle strength in the quadriceps hamstrings and gastrocnemius and compare strength deficits among the groups. The muscle recruitment patterns of all three groups healthy individuals and individuals with end-stage osteoarthritis and those who have undergone total knee replacement will be assessed using surface electromyography during gait cycle. The EMG analysis for the TKR group will be done on post operative day 5. The data will be subjected to statistical analysis. 
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