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CTRI Number  CTRI/2024/10/075313 [Registered on: 15/10/2024] Trial Registered Prospectively
Last Modified On: 08/10/2024
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   Virtual Reality-Based Exercises on symptom of Pain, joint position sense and Joint Functions in Osteoarthritis of knee 
Scientific Title of Study   Effectiveness of Immersive Virtual Reality Based Exercises on pain,Proprioception and Function in subjects with osteoarthritis of knee 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vaheedha s 
Designation  PhD Scholar 
Affiliation  Saveetha College of Physiotherapy,Saveetha Institute of Medical and Technical Sciences 
Address  Saveetha college of Physiotherapy, Saveetha Institute of Medical and Technical Sciences,Thandalam, Chennai,

Kancheepuram
TAMIL NADU
602105
India 
Phone  9030851129  
Fax    
Email  svaheedha123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  kumaresan Abathysagayam 
Designation  Professor and PhD Guide 
Affiliation  Saveetha College of Physiotherapy 
Address  Saveetha College of Physiotherapy,Saveetha Institute of Medical and Technical Sciences,Thandalam,

Kancheepuram
TAMIL NADU
602105
India 
Phone  7299934070  
Fax    
Email  kresh49@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vaheedha s 
Designation  PhD Scholar 
Affiliation  Saveetha College of Physiotherapy,Saveetha Institute of Medical and Technical Sciences 
Address  Saveetha college of Physiotherapy, Saveetha Institute of Medical and Technical Sciences,Thandalam, Chennai,

Kancheepuram
TAMIL NADU
602105
India 
Phone  9030851129  
Fax    
Email  svaheedha123@gmail.com  
 
Source of Monetary or Material Support  
Self funded study will be conducted in Apollo college of physiotherapy, Apollo Institute of Medical Sciences and Research, Chittoor, Andhra pradesh,India 517127 Apollo District Head Quarters Hospital, AIMSR,Chitoor,Andhrapradesh, India 
 
Primary Sponsor  
Name  Vaheedha S 
Address  Apollo college of physiotherapy, Apollo Institute of Medical Sciences and Research, Chittoor, Andhra pradesh, India, 517127 
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 
Vaheedha S  Chittoor District Head Quarters Hospital, Apollo Institute of Medical Science and Research.  Room no 31, Physio OPD, Apollo Chittoor District Head Quarters Hospital, Apollo institute of medical sciences and research, Chittoor-517001, Andhra Pradesh, India Chittoor
Chittoor
ANDHRA PRADESH 
9030851129

svaheedha123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee-Apollo Institute Of Medical Sciences and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Exercises along with Laser  Conventional exercises include single leg standing with eyes closed on the affected and non-affected limb for 10 seconds on a firm and soft surface, half step stance for 10 seconds, one legged balance for 10 seconds, marching, knee extensions with TheraBand, unilateral gluteal bridge, supine straight leg lifts, prone leg lifts with 3-5 repetitions 4 sets, in addition to receiving Laser Therapy three times per week for 6 weeks with low level laser power and treatment. In this research, TECH LASER, SS1000 is utilized with low-level laser therapy parameters: 808 nm Wavelength, 0.4 CM Length, 8 Joules/Point of Energy for each point over a 10-minute period totaling 128 Joules. The laser will be placed around the knee joint on eight points including the medial and lateral epicondyle of the tibia and femur, the medial and lateral knee joint gap, and the medial edge of the tendon of biceps femoris and semitendinosus muscle in the popliteal fossa.  
Intervention  Virtual reality along conventional Exercises,Laser  The experimental group will receive the interactive virtual reality game in addition to Conventional exercises,The VR used in the study is the Oculus Quest, Rewin Health and will be upgraded to Oculus Quest 2. The game includes Jerry and Jerrys Coastal Saga, where players stand on a virtual platform and move their lower limbs back and forth following pink arrows for guidance. A 5 minute warm up will be followed by 12 minutes of walking at their own pace and finished off with a 5-minute cool down. There are three levels (easy, medium, hard) for knee extension, hip flexion, and hip abduction exercises, with 5 to 25 repetitions in 4 sets. The blue sensor is placed at the shin bone of the tibia for knee extension and at the mid thigh for hip flexion 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Unilateral Knee joint involvement.
2. NPRS less than 7 Points
3.Based on 3 to 4 categories of KELLGREN AND LAWRENCE, having at least 6months of knee pain.
4.Both male and female subjects.
 
 
ExclusionCriteria 
Details  1. Any Recurrent knee injury, such as Tendon or Ligament Tear
2. Patients history of traumatic injury and surgery of knee joint
3. Unstable health conditions like heart, lung conditions
4. Patients unable to walk independently
systemic and psychiatric illness
5. Open wounds any ulcers in the foot or skin
6. Patients with Deep sensation impairement. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Joint Propriocpetion Test, 2.WOMAC,
3.NPRS 
4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
4.Range of Motion  4 weeks 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   22/10/2024 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [svaheedha123@gmail.com].

  6. For how long will this data be available start date provided 01-10-2024 and end date provided 05-10-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

 INTRODUCTION:

Knee osteoarthritis (OA) is one of the most common musculoskeletal disorders and represents a major cause of debilitation in affected individuals, The age of respondents ranged from 18–80 years, with a mean of 35 ± 13.11 (Omar W. Athomali et.al, 2005) In people aged was Approximately to worldwide (3.6% of population have knee osteoarthritis) 36,000/Million, Knee OA is the most common form of arthritis associated with functional impairment in middle aged and elder people, There is potential association between impaired knee proprioception and pathological changes during early stages of knee OA (Bennell KL et al 2003),There are several therapies including the recent technological interventions such as AI and VR for OA. VR Is a novel technology defined as “the use of interactive simulations created with computer hardware and software to present users with opportunities to engage in environment that appear to be a feel a similar to real-world objects and events, The contribution of vision and proprioception to retrieving information about own body location and movement at different stages of remembering i.e., encoding, storage and recall phases. Understanding this complex relationship is crucial for development of technologies that facilitate human navigation and to inform motor rehabilitation programme in patients with Knee OA (KOA), weakening and damage of the knee muscles, tendons, ligaments, and articular capsule is related to body’s proprioception decreases (Relph and Herrington, 2015).  The weakening and damage of proprioceptors make patients’ pain and perception abnormal could lead to the severe consequence of KOA (Bennell et al., 2003). Weak patients with poor proprioceptors have limited joint functional ability (van der Esch et al., 2007) The repeated proprioceptive training with functional elements increased cumulative neural inputs to the central nervous system via mechanoreceptors and proprioceptors in the joint capsules, ligaments, muscles, tendons, and skin.

NEED FOR THE STUDY: During each stage of osteoarthritis knee, many pathological changes take place the destruction of smooth cartilage that covers the ends of bones, reduction of joint space, and formation of new bone called osteophytes taking place on joint margins. All these changes lead to weakness of muscles around the joint, joint pain, Proprioceptive deficits, decreased physical functional activities of individuals, balance disturbances, etc. The study on virtual reality-based exercises in osteoarthritis (OA) knee treatment is crucial to address the growing need for innovative and patient-centric approaches in healthcare.

OBJECTIVES

Ø To find the effectiveness of immersive virtual reality-based exercises on physical function in subjects with osteoarthritis of the knee.

Ø To find the effectiveness of immersive virtual reality-based exercises on the range of motion in subjects with osteoarthritis of knee.

Ø To find the effectiveness of immersive virtual reality-based exercises in measuring the Pain in subjects with osteoarthritis of the knee.

 Methodology:

A total of 64 patients will be Recruited with unilateral osteoarthritis of knee based on selection criteria. Informed Consent and information sheet will be explained on obtained from all participants with their voluntary consent. Included participants will be The pre-participation evaluation form such as range of motion, numerical pain rating scale, womac questionarie, joint proprioception test after completion of the pre-test participants will be allocated into two groups by the concealed envelope method. Experimental group will be receiving virtual reality-based exercises along with conventional exercises, Laser and Control group both groups will be treated for 4 weeks 5 repetitions of 4 weeks

Stastical analysis:

Sample size calculated for 80% Population Proportion, 95% Confidence Interval, and 9% Margin Error for both experimental and control group samples will be allocated through concealed envelop as 32 in each group. Stastical analysis will be performed using Mann-Whitney U test for between- groups Comparison and Wilcoxon Test for within- groups comparisons

Excepted outcomes:

The primary excepted outcomes of the study include significant improvements in pain, functional outcome, proprioception, range of motion. Additionally, enhanced functional activity and proprioception post intervention is anticipated.

 
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