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CTRI Number  CTRI/2026/04/107564 [Registered on: 06/04/2026] Trial Registered Prospectively
Last Modified On: 18/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Calf Muscle Exercises on Pain and Movement in People with Knee Osteoarthritis 
Scientific Title of Study   The effect of calf muscle stretching and resistance training on the pain and functional outcomes of individuals with knee osteoarthritis: a quasi experimental 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  Pritam Mondal 
Designation  MPT Student 
Affiliation  SRM Institute of Science and Technology, 
Address  PT24, 4th floor, SRM College of Physiotherapy, SRM Institute of Science and Technology, SRM Nagar, Kattankulathur, Chengalpattu,TAMIL NADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone  6290920158  
Fax    
Email  pritampt0918@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Manova Prasanna Kumar D 
Designation  Assistant Professor 
Affiliation  SRM Institute of Science and Technology, 
Address  4th floor, SRM College of Physiotherapy, SRM Institute of Science and Technology, SRM Nagar, Kattankulathur, Chengalpattu,TAMIL NADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone  8220466030  
Fax    
Email  manovapd@srmist.edu.in  
 
Details of Contact Person
Public Query
 
Name  Pritam Mondal 
Designation  MPT Student 
Affiliation  SRM Institute of Science and Technology, 
Address  PT24, 4th floor, SRM College of Physiotherapy, SRM Institute of Science and Technology, SRM Nagar, Kattankulathur, Chengalpattu,TAMIL NADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone  6290920158  
Fax    
Email  pritampt0918@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Pritam Mondal 
Address  SRM College of Physiotherapy. SRM Institute of Science and Technology, SRM Nagar, Kattankulathur - 603 203, Chengalpattu District, Tamil Nadu 
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 Pritam Mondal PT  SRM Hospital  Orthopaedic ward 2nd floor and physiotherapy OPD 1st floor, SRMIST, SRM Nagar, Kattankulathur– 603203, Chengalpattu District, Tamil Nadu, India
Kancheepuram
TAMIL NADU 
6290920158

pritampt0918@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, SRM MEDICAL COLLEGE & RESEARCH CENTRE  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 
Intervention  Tradiotional plus calf muscle stretching strengthening  Isometric Quadriceps. Five second hold, two second relax. Ten repetitions. Supine Straight Leg Raise. Five second hold, five second relax. Ten repetitions. Prone Straight Leg Raise. Five second hold, five second relax. Ten repetitions. Passive Knee Flexion And Extension. Resistive Knee Flexion And Extension In Sitting With One kilogram Weight. Five second hold, five second relax. Ten repetitions. Shifting Center Of Gravity Left And Right, Front And Back In Standing While Holding A Support Table For Three minutes. Calf Muscle Stretching. Thirty second hold. Four repetitions. Calf Muscle Strengthening. Starting position is standing on the forefoot on a step. The person lifts the body up and then the heel is lowered down by dorsiflexing the ankle, and the cycle is repeated. The exercise is performed with the knee straight to eccentrically load the gastrocnemius and with the knee flexed to eccentrically load the soleus while lowering the heel. Fifteen repetitions for three sets. It can be progressed by using a rucksack with weights. Interferential Current Therapy. Customized according to the patient’s needs. Five sessions for fifteen minutes each are given or until the pain subsides. 
Comparator Agent  Traditional  Isometric Quadriceps. Five second hold and two second relax. Ten repetitions. Supine Straight Leg Raise. Five second hold and five second relax. Ten repetitions. Prone Straight Leg Raise. Five second hold and five second relax. Ten repetitions. Passive Knee Flexion And Extension. Resistive Knee Flexion And Extension In Sitting With One kilogram Weight. Five second hold and five second relax. Ten repetitions. Shifting Center Of Gravity Left And Right, And Front And Back In Standing While Holding A Support Table For Three minutes. Interferential Current Therapy. Customized according to the patient’s needs. Five sessions for fifteen minutes each are given or until the pain subsides. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Having knee pain for more than 3 months, BMI 18 to 30 kg/m², Patient who can walk independently, OA grade (Kellgren Lawrence) I, II and III, ACR criteria for OA knee (knee pain plus 3 out of 6 criteria fulfilment)
 
 
ExclusionCriteria 
Details  Person with any history of cognitive impairment, Person with any history of knee surgeries, Person with any history of neuromuscular disease, Person with any history of cardiopulmonary disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Index  Baseline (0 week) and post intervention (6 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
VAS (Visual Analogue Scale) score   Baseline (0 week) & post intervention (6 weeks) 
Flexibility of ankle dorsiflexion range by Goniometer  Baseline (0 week) & post intervention (6 weeks) 
 
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)   01/05/2026 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Knee osteoarthritis is a chronic degenerative disorder characterized by the progressive breakdown of articular cartilage, resulting in pain, stiffness, and reduced functional ability. It is one of the most common musculoskeletal conditions affecting the elderly population, particularly individuals above sixty years of age. The condition significantly affects daily activities such as walking, climbing stairs, and squatting. Various factors such as aging, obesity, genetics, trauma, and biomechanical alterations contribute to the development and progression of knee osteoarthritis. Globally, knee osteoarthritis is a major contributor to disability and reduced quality of life. In rural South India, the prevalence is reported to be relatively high, highlighting the need for effective rehabilitation strategies.

The aim of this study is to determine the effect of calf muscle stretching and resistance training on pain and functional outcomes in individuals with knee osteoarthritis. The calf muscles, especially the gastrocnemius, cross the knee joint and play an important role in maintaining knee stability and biomechanics. Weakness or tightness of these muscles may negatively influence knee joint function and contribute to increased pain and functional limitation. Despite their importance, limited research has focused on the role of calf muscle stretching and strengthening in the management of knee osteoarthritis.

This study adopts a quasi experimental design with a pre and post assessment approach. A total of sixty participants aged forty to sixty five years with clinically diagnosed knee osteoarthritis will be selected using purposive sampling from SRM Medical College Hospital and Research Centre. Participants will be divided into experimental and control groups. The experimental group will receive conventional physiotherapy exercises along with calf muscle stretching and strengthening, while the control group will receive only conventional physiotherapy exercises. The intervention will be conducted for six weeks.

Outcome measures include the Western Ontario and McMaster Universities Osteoarthritis Index, Visual Analogue Scale for pain, and ankle dorsiflexion flexibility measured using a goniometer. The findings of this study may help improve rehabilitation protocols and provide evidence based guidance for physiotherapists in managing knee osteoarthritis.

 
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