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CTRI Number  CTRI/2025/04/085811 [Registered on: 28/04/2025] Trial Registered Prospectively
Last Modified On: 28/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Hamstring Active Release Technique Program on knee Pain, Range of motion and Hamstring-to-Quadriceps strength ratio in patients with Knee Osteoarthritis 
Scientific Title of Study   Impact of Hamstring Active Release Technique Program on Pain, Range of motion and Hamstring-to-Quadriceps strength ratio in patients with Grade 1 and 2 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  Satwinder Kaur 
Designation  Student 
Affiliation  Maharishi Markandeshwar (Deemed to be University) 
Address  Room No. 2, Ground floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana

Ambala
HARYANA
133207
India 
Phone  8427669149  
Fax    
Email  satwinderkaurbpt2019@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sandeep Pattnaik  
Designation  Assistant Professor 
Affiliation  Maharishi Markandeshwar (Deemed to be University) 
Address  Room No. 2, Ground floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana

Ambala
HARYANA
133207
India 
Phone  9438565681  
Fax    
Email  physiosandeep94@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sandeep Pattnaik  
Designation  Assistant Professor 
Affiliation  Maharishi Markandeshwar (Deemed to be University) 
Address  Room No. 2, Ground floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana

Ambala
HARYANA
133207
India 
Phone  9438565681  
Fax    
Email  physiosandeep94@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Satwinder Kaur 
Address  Room No. 2, Ground floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, HARYANA, India, 133207 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Sandeep Pattnaik  Room No. 2, Ground floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, HARYANA, India, 133207 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Satwinder Kaur   Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation  Orthopedic Physiotherapy Research Laboratory, Ground floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, India, 133207
Ambala
HARYANA 
8427669149

satwinderkaurbpt2019@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Maharishi Markandeshwar Institute of Medical Sciences 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: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hamstring Active Release Technique Interferential Therapy Conventional exercise including Quadriceps isometric exercise, straight leg raise, hamstring set, bridging, heel rise  Hamstring Active Release technique-30 seconds stretch for 5 repetitions per session for 3 sessions per week for 4 weeks IFT-Carrier frequency 4khz, beat frequency 100hz, sweep frequency 150hz, 10 minutes per session, 3 sessions per week for 4 weeks Exercise Protocol- Quadriceps isometric exercise, straight leg raising, hamstring set, bridging, heel rise 10 seconds hold, 10 repetitions each per session with 5 seconds rest in between. 
Comparator Agent  Interferential Therapy Conventional exercise including Quadriceps isometric exercise, straight leg raise, hamstring set, bridging, heel rise  IFT-Carrier frequency 4khz, beat frequency 100hz, sweep frequency 150hz, 10 minutes per session, 3 sessions per week for 4 weeks Exercise Protocol- Quadriceps isometric exercise, straight leg raising, hamstring set, bridging, heel rise 10 seconds hold, 10 repetitions each per session with 5 seconds rest in between. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Individuals with grade 1 and 2 knee osteoarthritis.
Willingness to participate and provide informed consent.
Ability to understand and follow instructions.
 
 
ExclusionCriteria 
Details  Severe knee osteoarthritis grade 3 and 4.
Recent knee surgery or injury.
Any recent physiotherapy for knee osteoarthritis within last 3 months.
Neurological disorders affecting lower limbs.
Pregnancy or lactation.
Any other condition that may confound the results of the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.NPRS for pain intensity
2.Universal Goniometry to measure Active and Passive knee Range of Motion
3.Hamstring-to-quadriceps strength ratio using Modified Sphygmomanometer test
 
At baseline (Immediately after recruitment)
After 4 weeks of intervention (!2 sessions of treatment) 
 
Secondary Outcome  
Outcome  TimePoints 
Nil
 
Nil 
 
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)   15/05/2025 
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)   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 also known as degenerative joint disease, is typically the result of wear and tear of the articular cartilage. It may lead to muscle weakness, increased joint loading, alteration in the gait pattern  and increase the knee adduction movement. The objective of the study is to determine the impact of the Hamstring Active Release Technique (ART) program on range of motion in patients with grade 1 and 2 knee osteoarthritis. Active release technique is a manual therapy for the recovery of soft tissue function that involve the removal of adhesions, which can cause pain, stiffness, and muscle weakness. To determine the impact of the Hamstring Active Release Technique (ART) program on range of motion and the Isokinetic Hamstring to Quadriceps Strength Ratio in patients with Grade 1 And 2 Knee Osteoarthritis. On the basis of inclusion and exclusion criteria. Subjects will be randomly allocated into Group 1, Group 2 through computer based random allocation techniques. Group 1 will receive Active release technique with conventional physiotherapy treatment and Group 2 will receive only conventional physiotherapy treatment. Pre-test and post-test assessment will be done by Numerical Pain rating scale (NPRS), Goniometer to measure Active and Passive range of motion and hamstring and quadriceps strength ratio using Sphygmomanometer test. This research aligns with a patient-centered approach, and a deeper understanding of the musculoskeletal health, and the choice of additional physiotherapy treatment approaches.


 
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