| 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
|
|
|
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
|
|
|
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
|
|
|
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. |