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CTRI Number  CTRI/2025/10/095837 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   effect of different physiotherapy exercises on pain, balance, and walking ability in people with knee osteoarthritis. 
Scientific Title of Study   Comparing the Effectiveness of EMG Biofeedback vs. Structured Sensory-Motor Training on Pain, Deformity, Balance, and Gait in Patients with Knee Osteoarthritis: A experimental study 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akshay Singh Parihar 
Designation  postgraduate student (MPTh), Department of neurophysiotherapy) 
Affiliation  RJS College of Physiotherapy 
Address  RJS College of Physiotherapy, Kokamthan, Kopargaon,Ahmednagar, Maharashtra

Ahmadnagar
MAHARASHTRA
423601
India 
Phone  8208639371  
Fax    
Email  ap0976882@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Moushumi Debnath 
Designation  HOD Neurophysiotherapy departmentRJS College of Physiotherapy 
Affiliation  RJS College of Physiotherapy 
Address  RJS College of Physiotherapy, Kokamthan, Kopargaon,Ahmednagar, Maharashtra

Ahmadnagar
MAHARASHTRA
423601
India 
Phone  7977891487  
Fax    
Email  mdebnath27@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr R S Gangatharan 
Designation  Principal RJS College of Physiotherapy 
Affiliation  RJS College of Physiotherapy 
Address  RJS College of Physiotherapy, Kokamthan, Kopargaon,Ahmednagar, Maharashtra

Ahmadnagar
MAHARASHTRA
423601
India 
Phone  9840644110  
Fax    
Email  ganganeuro76@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Akshay Singh Parihar 
Address  RJS COLLEGE OF PHYSIOTHERAPY,KOKAMTHAN, KOPARGAON, AHMEDNAGAR, MAHARASHTRA,INDIA -423601 
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 Akshay Singh Parihar  Rashtrasant Janardhan Swami College of Physiotherapy  SJS Hospital, OPD OF Neurophysiotherapy department ,Rashtrasant Janardhan Swami College of Physiotherapy, Kokamthan Tal- Kopargaon, Dist. Ahmednagar, Maharashtra -423601.
Ahmadnagar
MAHARASHTRA 		 8208639371

ap0976882@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RJS college of Physiotherapy ethics committee  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 
Comparator Agent  Conventional Physiotherapy  From 0–2 weeks, conventional physiotherapy includes patient education, pain management with ice and TENS, gentle mobility exercises (heel slides, dynamic quads, ATM, patellar mobilization), basic strengthening (static quads, hams, glutes, SLR, adductor/abductor squeeze), and simple balance training like weight shifts. During 2–4 weeks, pain management continues, mobility is further improved with stretching of hamstrings, quadriceps, and TA, while strengthening progresses with both open and closed chain exercises (mini squats, step-ups, resisted quads, VMO strengthening, hamstring curls). Proprioception is added with single-leg stance and weight shifts, along with aerobic treadmill walking and gait training to normalize walking patterns. By 4–6 weeks, strengthening advances with lunges, wall squats, step-ups at higher levels, resisted quads, SLR, and hamstring curls with weights. Neuromuscular coordination and balance are trained through tandem standing, side stepping, and figure-of-8 walking, while functional and endurance activities include stair climbing, treadmill, and sideways walking. 
Intervention  EMG Biofeedback training  Biofeedback training will be conducted using a Myomed 932, a two-channel EMG device, with electrodes placed after proper skin preparation. For VMO monitoring, electrodes will be positioned 4 cm superior and 3 cm medial to the superomedial patella border, and for RF, at the junction of the middle and lower third of the thigh along the muscle fiber direction. A reference electrode will be placed inferior to the tibial tubercle. Training will run for five weeks, five days per week, with patients performing contractions beyond 80% of their maximum voluntary contraction, sustained for five seconds with a ten-second rest. Exercises include isometric quadriceps (supine with towel under knee), terminal knee extension (from 30° to 0° seated), straight leg raising (supine, lifting leg after quadriceps contraction), and isometric hip adduction (supine, pressing a pillow between knees). Each exercise will be performed in three sets of ten repetitions while maintaining the audible feedback signal. 
Intervention  Structured sensory motor training protocol  Participants will undergo a structured sensory-motor training program for 6 weeks, delivered 5 days per week, 45–60 minutes per session under physiotherapist supervision. The program is divided into three progressive phases. Phase I (0–2 weeks): Pain relief with interferential therapy (IFT, 80–100 Hz, 10–15 min), basic proprioceptive training (ankle circles, alphabet drawing), static and dynamic balance (tandem stance, weight shifts), strengthening (heel/toe raises, step-ups, theraband knee extensions), and low-resistance cycling. Phase II (2–4 weeks): Progression with joint repositioning (3×12 reps), balance on foam/balance board with eyes closed, seated perturbation for postural control, functional strengthening (step-ups, resisted TKE), and cycling up to 10 minutes. Phase III (4–6 weeks): Advanced proprioception with mirror/theraband, dynamic balance (heel-to-toe, tandem walking, clapping on balance board), stability training (perturbations, single-leg stance, BOSU reach-outs), gait training with hurdles and dual tasks, and endurance cycling (10 min, moderate resistance). The protocol emphasizes gradual progression from pain management to advanced balance, strength, mobility, and functional gait activities to improve stability and functional independence. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient should be Cooperative and motivated.
2. Those who are willing to voluntarily participate in the study.
3. Individuals diagnosed with Knee Osteoarthritis grade 2 and 3 according to
kellgren-lawrence criteria and x ray investigation.
4. Functional limitation – difficulty in ADLs
5. Genu varum 
 
ExclusionCriteria 
Details  Osteoarthritis Grade 1 and 4 according to kellgren-lawrence criteria
2. Underwent any surgery related to knee
3. Cognitive impairment
4. Neurological conditions
5. CVS and RS complications
6. Individuals who are not co-operative during the study  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Numerical Pain Rating Scale (NPRS)
2)WOMAC (Western Ontario and McMaster Universities Osteoarthritis
Index) Scale
3)Q-Angle or Patellofemoral Angle.
4) POMA
 		 At baseline and 8 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   01/11/2025 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Study Overview
Knee osteoarthritis is a common degenerative joint condition that leads to pain, stiffness, deformity, and impaired mobility, which affects balance and quality of life. Physiotherapy plays an important role in management through different exercise approaches.

Aim
This study aims to compare the effectiveness of three physiotherapy interventions in individuals with knee osteoarthritis. The first group will receive electromyographic biofeedback training, which uses a device that records muscle activity and helps patients improve voluntary muscle control. The second group will undergo sensory motor training, a structured program that focuses on joint position sense, balance, and walking ability. The third group will receive conventional physiotherapy, which consists of pain relieving methods, range of motion exercises, and strengthening exercises.

Methods
Participants will be randomly divided into three groups. Each group will attend supervised physiotherapy sessions three times per week for eight weeks. Assessments will be carried out before and after the program to measure pain, knee deformity, balance, and walking ability.

Expected Outcome
The results will identify which physiotherapy approach is more effective in reducing pain and improving functional outcomes in patients with knee osteoarthritis.

 
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