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CTRI Number  CTRI/2025/03/083652 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On: 27/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Comparing Exercises With and Without Weight on the Legs for Knee Pain and Movement in People With Osteoarthritis in Chengalpattu District 
Scientific Title of Study   Comparison of Weight Bearing Functional Exercise and Non Weight Bearing Quadriceps Strengthening Exercise on Pain and Function for People with OA knee in Chengalpattu District 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  STANLEY ZION C 
Designation  UG Student 
Affiliation  SRM College of Physiotherapy 
Address  Room no. PT16, BPT 8th semester, SRM college of Physiotherapy, SRM Institute of Science and Technology, SRM Nagar, Kattankulathur, Chengalpattu, Tamilnadu - 603203

Kancheepuram
TAMIL NADU
603203
India 
Phone  8056290363  
Fax    
Email  stanleyzion2003@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SUBICHA T S 
Designation  Assistant Professor 
Affiliation  SRM College of Physiotherapy 
Address  Room no. PT13, Staff room, SRM college of physiotherapy, SRM Institute of Science and Technology, SRM Nagar, Kattankulathur, Chengalpattu, Tamilnadu - 603203

Kancheepuram
TAMIL NADU
603203
India 
Phone  7200337170  
Fax    
Email  subichat@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  SUBICHA T S 
Designation  Assistant Professor 
Affiliation  SRM College of Physiotherapy 
Address  Room no. PT13, Staff room, SRM college of physiotherapy, SRM Institute of Science and Technology, SRM Nagar, Kattankulathur, Chengalpattu, Tamilnadu - 603203


TAMIL NADU
603203
India 
Phone  7200337170  
Fax    
Email  subichat@srmist.edu.in  
 
Source of Monetary or Material Support  
SRM Medical College Hospital, Mahatma Gandhi Road, SRM Institute of Science and Technology, SRM Nagar, Kattankulathur, Chengalpattu, Tamilnadu - 603203 
 
Primary Sponsor  
Name  STANLEY ZION C 
Address  Room no. PT16, BPT 8th semester, SRM college of Physiotherapy, SRM Institute of Science and Technology, SRM Nagar, Kattankulathur, Chengalpattu, Tamilnadu - 603203 
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 STANLEY ZION C  SRM Medical College Hospital and Research Centre   Electrotherapy OPD, Physiotherapy dept, SRM Medical College hospital and Research Centre, Mahatma Gandhi Road, SRM institute of Science and Technology, SRM Nagar, Kattankulathur, Chengalpattu - 603203
Kancheepuram
TAMIL NADU 		 8056290363

stanleyzion2003@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM MEDICAL COLLEGE HOSPITAL AND 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  Non weight bearing Quadriceps strengthening exercise program  Weeks 0-2 1. Quads over a roll: 2 sets, 3-5 reps (1 min) 2. Knee extension in sitting: 2 sets, 3-5 reps (1 min) 3. Knee extension with hold at 30 degrees: 2 sets, 3-5 reps (1 min) 4. Straight leg raise: 2 sets, 3-5 reps (1 min) 5. Short arc knee extension: 2 sets, 3-5 reps (1 min) Weeks 3-5 1. Quads over a roll: 3 sets, 6-8 reps (1 min) 2. Knee extension in sitting: 3 sets, 6-8 reps (1 min) 3. Knee extension with hold at 30 degrees: 3 sets, 6-8 reps (1 min) 4. Straight leg raise: 3 sets, 6-8 reps (1 min) 5. Short arc knee extension: 3 sets, 6-8 reps (1 min) Weeks 6-8 1. Quads over a roll: 3 sets, 8-12 reps (1min) 2. Knee extension in sitting: 3 sets, 8-12 reps (1 min) 3. Knee extension with hold at 30 degrees: 3 sets, 8-12 reps (1 min) 4. Straight leg raise: 3 sets, 8-12 reps (1 min) 5. Short arc knee extension: 3 sets, 8-12 reps (1min) 
Intervention  Weight bearing functional exercise  Weight Bearing Functional Exercises 0-2 Weeks: 1. Forward/Backward Sliding with Thera Band: 2 sets of 3-5 reps (1 min) 2. Wall Push:2 sets of 3-5 reps (1 min) 3. Wall Squat: 2 sets of 3-5 reps (1 min) 4. Step Ups: 2 sets of 3-5 reps (1 min) 5. Sideways Sliding with Thera Band: 2 sets of 3-5 reps (1 min) 3-5 Weeks: 1. Forward/Backward Sliding with Thera Band: 3 sets of 6-8 reps (1 min) 2. Wall Push: 3 sets of 6-8 reps (1 min) 3. Wall Squat: 3 sets of 6-8 reps (1 min) 4. Step Ups: 3 sets of 6-8 reps (1 min) 5. Sideways Sliding with Thera Band: 3 sets of 6-8 reps (1 min) 6-8 Weeks: 1. Forward/Backward Sliding with Thera Band: 3 sets of 8-12 reps (1 min) 2. Wall Push: 3 sets of 8-12 reps (1 min) 3. Wall Squat: 3 sets of 8-12 reps (1 min) 4. Step Ups: 3 sets of 8-12 reps (1 min) 5. Sideways Sliding with Thera Band: 3 sets of 8-12 reps (1 min) 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  subjects already diagnosed with OA knee,
subjects who are willing to participate 
 
ExclusionCriteria 
Details  knee surgery has been done in past 6 months,
planned for knee surgery in the past 9 months,
if the person had hip/knee replacement in the past,
past fractures of knee and malignancy,
subjects without knee X-ray,
subjects who are not willing to participate in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Numerical pain rating scale
2. WOMAC Scale for OA 		 10 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Age, gender, BMI   5 minutes 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   07/04/2025 
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="0"
Months="2"
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   To understand the relative effectiveness of weight bearing functional exercise and non weight bearing quadriceps strengthening exercise in managing pain and improving function in individuals with OA knee. This knowledge can help us to identify the most appropriate exercise modalities for different patient populations, leading to more personalized and effective treatment strategies. It is important for optimising treatment, improving patient outcomes, and advancing evidence- based practice in the field of musculoskeletal rehabilitation. 
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