CTRI/2025/07/090350 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On:
02/07/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Physiotherapy (Not Including YOGA)
Study Design
Single Arm Study
Public Title of Study
Using a Virtual Wall to Improve Balance and Fitness in People with Knee Pain
Scientific Title of Study
Efficacy of D-wall on fitness and balance in knee osteoarthritis patients:An experimental 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
Arohi Chandure
Designation
postgraduate student
Affiliation
Dr. Dy Patil College of Physiotherapy
Address
Room no 1, floor 3 ,Dr. D Y Patil College of Physiotherapy,third floor, Musculoskeletal sciences department,3, sant tukaram nagar, pimpri colony, pimpri , Pune
Pune MAHARASHTRA 411018 India
Phone
8830949079
Fax
Email
arohichandure@gmail.com
Details of Contact Person Scientific Query
Name
Dr Seema Saini
Designation
Professor
Affiliation
Dr. Dy Patil College of Physiotherapy
Address
Dr. D Y Patil College of Physiotherapy,third floor, MSK department,3, sant tukaram nagar, pimpri colony, pimpri , Pune
Pune MAHARASHTRA 411018 India
Phone
8087564345
Fax
Email
Seema.saini@dpu.edu.in
Details of Contact Person Public Query
Name
Arohi Chandure
Designation
Postgraduate student
Affiliation
Dr. Dy Patil College of Physiotherapy
Address
Dr. D Y Patil College of Physiotherapy,third floor,room no 1 Musculoskeletal sciences ,department,3, sant tukaram nagar, pimpri colony, pimpri , Pune
Pune MAHARASHTRA 411018 India
Phone
08830949079
Fax
Email
arohichandure@gmail.com
Source of Monetary or Material Support
Dr. D Y Patil College of Physiotherapy ,MSK department, third floor, 3 , Dr.D.Y. Patil college road, Sant tukaram nagar, Pimpri Colony, Pimpri- Chinchwad, Pune, Maharashtra 411018
Primary Sponsor
Name
Arohi Chandure
Address
MSK department, third floor, 3 , Dr.D.Y. Patil college road, Sant tukaram nagar, Pimpri Colony, Pimpri- Chinchwad, Pune, Maharashtra 411018
Type of Sponsor
Other [SELF FUNDED]
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 Arohi Chandure
Dr. D Y Patil College of Physiotherapy OPD ground floorOPD
Musculoskeletal Sciences department , third floor , 3rd cabin or room , Dr. D.Y.Patil college of physiotherapy , pune , 411018 Pune MAHARASHTRA
After ethical approval and participant screening, eligible individuals provide informed consent. Baseline pre-test Measurements are recorded before starting a 4-week VR based rehabilitation program focused on posture, balance, and functional improvement. Post-intervention, the same tests are repeated to assess progress. Statistical analysis is conducted to compare pre- and post-results, highlighting the impact of D-wall VR on knee OA rehabilitation. The study supports the potential of VR in enhancing treatment outcomes and patient engagement.As the participants move ahead with good score the module level will be getting upgraded to next level which will be tougher than the previous , each sessions shall be taking each 45 minutes mostly depends on the goal achievement of the patient
Comparator Agent
nil
nil
Inclusion Criteria
Age From
45.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
Age: Adults aged 45 to 60 years, as knee
osteoarthritis commonly affects
this age
group.
Diagnosis:
Clinically/radiographically
diagnosed with osteoarthritis of the knee (based on radiographic evidence or clinical criteria such as the Kellgren-Lawrence scale).
Pain Level: Participants experiencing mild to moderate(LESS THAN 7) knee pain, typically assessed via a pain scale (NPRS).
Mobility Status: Participants able to walk independently
ExclusionCriteria
Details
Recent knee replacement surgery or surgery during the study period.
Severe osteoarthritis
score above 8 on NPRS
Cardiovascular Conditions
Uncontrolled cardiovascular conditions or respiratory issues
Pregnancy
Contraindications of certain physical activities
Diagnosed cognitive impairments
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Participant Blinded
Primary Outcome
Outcome
TimePoints
Dwall by technobody. fitness and balance shall be assesed with the help of virtual reality device that is Dwall
baseline assesment pre and post intervention assesment. excercise inbuilt modules score will be recorded and compared. the progress with the noted scores as per the module will be recorded after every session and estimated after 4 weeks of duration . each session will be max 45 mins
Secondary Outcome
Outcome
TimePoints
nil
nil
Target Sample Size
Total Sample Size="60" Sample Size from India="60" 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)
09/09/2025
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="6" 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
INTRODUCTION
Osteoarthritis (OA) of the knee is a common musculoskeletal disorder that primarily affects the elderly and often causes chronic knee pain. Both osteoarthritis and persistent knee pain are major contributors to disability, significantly reducing the well-being and quality of life of those who suffer from both(1). NSAIDs, acetaminophen, and prescription drugs such as opioids are currently the most common pharmacological therapies for chronic knee OA pain. These alternate forms of therapy, however, never offer complete pain relief and frequently have adverse effects. Thus, the demand for safe and efficient non-pharmacological approaches to chronic pain treatment remains. Additionally, there is evidence that virtual reality (VR) may be a useful tool for lowering stress and chronic pain. While there is strong evidence demonstrating that VR is effective for reducing acute pain, there is limited evidence on the effects of virtual reality on chronic pain, with an even greater gap in knowledge regarding VR use with older adult populations specifically(3).
Based on available data, postural instability is less common in older persons with bilateral or unilateral knee OA. It may be possible to identify possible causes of impairment in these individuals and provide a more thorough treatment of the condition if it is known how knee OA affects balance. The functional knee joint is subjected to continual strain. Though active muscle contraction and bone geometry offer stability to the knee joint during normal daily activities, mechanoreceptors help to maintain stability by providing sensory feedback that facilitates antagonist-agonist muscle activity (3). According to the Osteoarthritis Research Society International (OARSI), osteoarthritis is a “disorder involving movable joints characterized by cell stress and extracellular matrix degradation initiated by micro- and macroinjury, which activates maladaptive repair responses, including pro-inflammatory pathways of innate immunity.” The disease starts with an imbalance in the way joint tissues function at a molecular level. This is followed by physical changes, like cartilage wearing down, bone reshaping, growth of bone spurs, joint inflammation, and loss of normal joint movement, which can eventually lead to illness.
OA was believed to be a "wear-and-tear" condition with purely structural and peripheral causes. In recent years, OA has been recognized as a complex, multidimensional disease with central and peripheral pain pathways, where severe changeable and non-modifiable variables interact to produce its clinical signs and symptoms. In OA, Rayahin et al. found that extensor knee muscle weakness, age, obesity, catastrophizing, and high disease severity are all associated with pain. Anxiety, increased despair, pain-related cognitions (pain catastrophizing, self-efficacy for pain, acceptance), psychological resources, the capacity to express pain to others, and social engagement are just a few of the numerous psychosocial aspects that contribute to OA symptoms. Physical activity and inactivity are key elements for patients with OA due to their association with physical function(4).
Exercise therapy is one of the most popular and successful ways to deal with these issues. As the primary therapy for knee OA and chronic knee pain, exercise is recommended by several care standards. However, the traditional method of delivering exercise therapy typically involves patients attending in-person sessions at clinics, which requires time, motivation, and financial investment, or having patients complete prescribed exercises at home with little oversight and limited access to resources, which can result in poor performance and adherence. To get around these obstacles, technologies have been used in recent years. For instance, patients and physical therapists can consult remotely over the phone. Additionally, multifunctional mobile and online applications that incorporate motion and physical activitytracking sensors have been created to manage health issues and exercise progress. Exercise games that are supplied via computers, video game consoles, or virtual reality are used in several treatment modalities to enhance patients’ participation and interactions with exercise therapy. The support of such technologies is increasing the accessibility, affordability, and attractiveness of exercise programs to treat knee OA and chronic knee pain(1).
The primary objectives of clinical therapy methods are to improve knee joint functionality, reduce discomfort, and halt the course of the disease. Exercise therapy is a key and very successful treatment option in this situation. However, conventional exercise plans require onsite care at medical facilities, which presents time, motivation, and cost constraints.
Furthermore, although being financially feasible, at-home workouts frequently lack efficacy and compliance because of difficulties with supervision and resource accessibility. VR technology shows promise as a solution to the problems of improving multidimensional patient training. "Interactive simulations created using computer hardware and software to provide users with immersive experiences, allowing them to engage in environments closely related to real-world objects and events" is how VR is described as an innovative technology. Immersion and presence are the two core components of virtual reality. Semi-immersive or non-immersive VR systems and fully immersive VR systems are the two primary categories into which VR devices and systems fall. 2D display panels are used to create non-immersive virtual reality (VR), which allows users to engage with the virtual world from a "external" viewpoint while still being aware of their real surroundings. A big screen is usually incorporated into semiimmersive VR to project the virtual world. Users interact with the virtual environment via innovative interface devices while still experiencing the actual world, resulting in partial immersion and a strong presence. Head-mounted displays (HMDs), which separate users from the outside world and submerge them in a three-dimensional environment, are usually used to create fully immersive virtual reality. Immersion experiences enhance this feeling of "being there" by enabling users to move their bodies in the virtual world.
Furthermore, VR can be used to create a rehabilitation environment in which users perform particular exercises while being evaluated, which will encourage them to practice extensively, all of which are essential steps in the rehabilitation process. Nevertheless, there isn’t enough data yet to support VR’s advantages in KOA rehabilitation. According to a review, there is conflicting evidence about the effectiveness of VR-based therapies over traditional physical therapy in the rehabilitation of patients with osteoarthritis, including those having complete knee replacements. Therefore, this systematic review and meta-analysis evaluate and analyse the rehabilitative effects of VR-based exercise for KOA patients(5). The Osteoarthritis Research Society International states that in 2019, land-based exercise is a key treatment for osteoarthritis in the knee, for which strength training in the lower limbs is frequently advised. Exercise plans in clinical practice frequently include unsupervised at-home exercise after initial physician monitoring. One of the long-term objectives for knee osteoarthritis should ideally be regular exercise; however, adherence to at-home exercise is frequently low. Thus, methods that boost adherence to at-home workouts are required.
According to recent research, advancements in technology may make exercise programs appealing, which would enhance clinical results and compliance. In this regard, innovative methods like virtual reality (VR) have drawn interest as possible treatments to improve exercise compliance and results for individuals with osteoarthritis in their knees. Virtual reality is a digital technology that uses interactive simulations made with computer hardware and software to give people the chance to interact with surroundings that look and feel like things and events that resemble the real world. A growing number of studies have shown that VRassisted therapies can be effective in managing chronic pain. By diverting their attention to video games, virtual reality (VR) helps users become more pain tolerant by distracting them from their unpleasant pain sensations. Users’ ability to perform and motivation to work out are further improved by its interactive components. VR also helps to develop skills for managing painful sensations by activating the visual, auditory, and proprioceptive senses. Numerous studies have demonstrated that VR-assisted physical therapy can help patients with neck and lower back pain by lowering pain and improving function. On the other hand, little is known about how well VR-assisted physical therapy works for osteoarthritis in the knee. Only a few studies, as far as we are aware, have assessed non-immersive VR-assisted balance and proprioception training; the results indicated that it may help knee osteoarthritis patients minimise pain and function better. Since evidence has highlighted that exposure to immersive VR can elicit a better sense of presence and potentially impact the effectiveness of
VR treatments, it is worth exploring immersive VR-assisted physical therapy in the rehabilitation of knee osteoarthritis(2).
Osteoarthritis (OA) was the fourth most common cause of disability worldwide. OA is a chronic, slowly progressing degenerative disease of the joint that affects the articular cartilage and causes pain, swelling, and loss of function. Several joints, including the knee, hip, ankle, wrist, cervical, and lumbar, are impacted by OA. Hip and knee OA is the eleventh most common cause of disability worldwide out of 291 conditions. In India, 22%–39% of the
1.252 billion population suffer from OA, with the overall prevalence of knee OA at 28.7%
(6). Osteoarthrosis (OA), often known as degenerative joint disease, is a progressive joint condition shaped by hypertrophy of nearby soft tissue and bone, focal loss of cartilage, and little signs of inflammation. Chronic osteoarthritis in its hypertrophic form is synonymous with this definition. One of the most well-known causes of progressive impairment in the world is OA. The ageing population is the primary cause of the rising prevalence of OA worldwide. Approximately 60% of males and 70% of women over 65 suffer from OA. However, the estimated prevalence and incidence of OA may differ based on the disease definition, the joints evaluated, and the population being researched. As a degenerative disease, OA worsens with age, increasing the related social and medical issues and eventually necessitating substantial comprehensive therapy. After the age of 45 approximately, the risk of OA rises significantly every ten years. Osteoarthritis gradually impairs a patient’s mobility, independence, and social engagement, which lowers their overall quality of life. Non-pharmacological treatments for degenerative joint disease concentrate on enhancing function, lowering pain, and raising the patient’s quality of life to lessen the side effects of therapy. Recent advancements in medical technology have led to the gradual integration of computer-assisted therapies into rehabilitation. In recent decades, new technologies in rehabilitation have been developed, from the simplest forms of biofeedback implementations to hardware platforms and motion capture systems augmented by biofeedback, augmented reality (AR) systems, and virtual reality (VR) systems(7). People with knee OA require continual support from healthcare experts to make the necessary behavioural changes to exercise and lose weight over time. The National Institute for Health and Care Excellence (UK) recommends digital and mobile health interventions as an option for any person who would benefit from improving their diet and/or increasing physical
activity(8).
Need of study
Millions of people suffer from the common and crippling ailment known as knee osteoarthritis (OA), which is especially common in the elderly. Even though they are frequently recommended, traditional pharmaceutical treatments like NSAIDs, and opioids frequently do not offer full relief and have unfavourable side effects. Furthermore, even though exercise therapy is acknowledged as a very successful non-pharmacological intervention, there are several obstacles to its implementation, such as time commitment, expense, and low adherence to at-home programs because of a lack of motivation and supervision.
The efficiency of rehabilitative therapies can now be improved because to technological improvements, especially in virtual reality (VR). According to preliminary data, virtual reality (VR) presents a compelling substitute for conventional fitness treatment as a means of lowering stress and discomfort through immersive settings. Regarding VR’s long-term impact on chronic pain, especially in older persons with knee OA, there is, however, little data. Additionally, there is still a lack of research on the use of VR in rehabilitation, particularly concerning its potential to enhance functional outcomes like balance and postural stability, which are crucial for patients with knee OA.
To fill up the existing knowledge gaps about the efficacy of VR-assisted therapy in knee OA, this investigation is required. This study aims to offer important insights into the potential role of virtual reality (VR) in increasing patient engagement and rehabilitation results by investigating how well VR works to improve pain management, fitness and balance. The study’s conclusions may help guide future treatment recommendations and create more approachable, interesting, and successful rehabilitation programs for patients with knee OA, lessening the disease’s toll on both patients and healthcare systems.