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CTRI Number  CTRI/2026/03/105102 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 28/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effect of Virtual Reality–Based Rehabilitation Compared to Accelerated Rehabilitation Exercises on Recovery and Inflammatory Markers After Total Knee Replacement Surgery 
Scientific Title of Study   Effect Of Virtual Reality Versus Accelerated Rehabilitation Protocols On Inflammtory Biomarkers And Fnctions As Predictors Of Recovery In Total Knee Arthroplasty : A Pilot 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  Dr Vijay Kage 
Designation  Professor and Dean, Department of Orthopaedic Physiotherapy 
Affiliation  KAHER Institute of Physiotherapy, Belagavi 
Address  KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room No. 18, Nehru Nagar, Belagavi, Karnataka-590010 Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9845271899  
Fax    
Email  vijaykage@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijay Kage 
Designation  Professor and Dean, Department of Orthopaedic Physiotherapy 
Affiliation  KAHER Institute of Physiotherapy, Belagavi 
Address  KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room No. 18, Nehru Nagar, Belagavi, Karnataka-590010 Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9845271899  
Fax    
Email  vijaykage@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Sakshi V Dhamnekar 
Designation  Postgraduate student (Orthopaedic Physiotherapy)  
Affiliation  KAHER Institute of Physiotherapy, Belagavi 
Address  KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room No. 18, Nehru Nagar, Belagavi, Karnataka-590010 Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  6361463382  
Fax    
Email  sakshivdhamanekar011@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Sakshi V Dhamnekar 
Address  KAHER Institute of Physiotherapy,Belagavi, Karnataka, India 590010 
Type of Sponsor  Private medical college 
 
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 Vijay Kage  KLES Dr. Prabhakar Kore Hospital and MRC Nehru Nagar, Belagavi  KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room No. 18, Nehru Nagar, Belagavi, Karnataka 590010 Belgaum KARNATAKA Belgaum, KARNATAKA
Belgaum
KARNATAKA 		 09845271899

vijaykage@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethical Committe, KLEU Institute of Physiotherapy, Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Total Knee Arthroplasty 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Accelerated post-operative rehabilitation protocol  Participants will receive a Accelerated post-operative rehabilitation protocol consist of isometrics exercise, SLR, Ambulation with knee immobilizer, Initiate active ROM exercise, out of bed exercise, and Patellar mobilization. All interventions will be administered under physiotherapist supervision. 3 sessions per week will be administered for 3weeks by a trained physiotherapist.  
Intervention  Virtual reality based- balance training following total knee replacement  Participants will receive a Virtual reality based- balance training following total knee replacement consist Of Knee flexion and balance training exercise, extension exercise , Walking using Assistive devices and static balance training exercise, gait training and dynamic training, interactive games.All interventions will be administered under physiotherapist supervision. 3 sessions per week will be administered for 3weeks by a trained physiotherapist.  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1] Participate all genders
2] Participate with age group of above 50 years
3] Participants with post op unilateral TKA
4] Willingness to participate and provide informed consent
 
 
ExclusionCriteria 
Details  1]Participants with Revised and bilateral TKR
2]Participants having pre- existing inflammatory and auto immune disorders
3]Participants with any infection or sepsis
4]Subjects should not have any recent other surgeries
5]ubjects with uncontrolled diabetes and hypertension
6]History of malignancy
7]Any musculoskeletal injury to other joint
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain measured using the Numeric Pain Rating Scale.  Pain will be assessed at baseline & three weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
1]Inflammatory biomarkers: C-Reactive Protein and TNF alpha
2]Assessment of Functional mobility using timed up and go test & 4 meter- Gait speed
3]Assessment of Range of motion using goniometer  		 1]Inflammatory biomarkers: C-Reactive Protein and TNF alpha will be assessed at baseline & three weeks.
2]Functional mobility using timed up and go test & 4 meter- Gait speed will be assessed at baseline & three weeks.
3]Range of motion using goniometer will be assessed at baseline & three weeks.  
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   11/03/2026 
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="6"
Months="0"
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   The pilot study aims to compare the effects of the Virtual Reality versus Accelerated rehabilitation protocol on pain ,inflammatory biomarkers , knee mobility and functional mobility in individuals with Total Knee Arthoplasty .
Primary and secondary outcomes will include inflammatory biomarkers (C-reactive protein and Tumor Necrosis Factor-alpha), pain intensity (Numeric Pain Rating Scale), functional mobility (Timed Up and Go test and 4-meter gait speed), and knee range of motion (flexion and extension measured using a goniometer). Assessments will be conducted at baseline and at specified follow-up intervals.

 
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