Clinical trial NCT06735963: Evaluating the Impact of a Meta Quest 3 Gamified VR Rehabilitation Program in Knee Osteoarthritis
Official title: Evaluating the Impact of a Meta Quest 3 Gamified VR Rehabilitation Program on Pain, Functionality, Disability, and Balance in Knee Osteoarthritis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthristis
Keywords: osteoarthritis
virtual reality
game
rehabilitation
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if a gamified virtual reality (VR) rehabilitation program can effectively reduce pain, improve functionality, and enhance balance in adults aged 40-64 years diagnosed with knee osteoarthritis. The main questions it aims to answer are:

Can the VR rehabilitation program reduce pain and disability compared to conventional physical therapy alone? Can the VR rehabilitation program improve balance and functionality in patients with knee osteoarthritis? Researchers will compare a group receiving the VR-based rehabilitation program alongside conventional therapy to a group receiving only conventional therapy to see if the addition of VR leads to superior outcomes.

Participants will:

Undergo either VR-based rehabilitation combined with conventional therapy or conventional therapy alone.

Complete assessments at three time points (baseline, 3 weeks, and 7 weeks) using measures such as pain scales, disability indices, and balance tests.

Detailed description: This randomized controlled trial will evaluate the impact of a gamified virtual reality (VR) rehabilitation program using the Meta Quest 3 device on pain, functionality, disability, and balance in individuals with knee osteoarthritis (OA). The study aims to address the limitations of traditional physical therapy by integrating immersive and engaging VR exercises to enhance patient adherence and therapeutic outcomes.

Eligible participants will be adults aged 40-64 years diagnosed with stage 2 or 3 knee OA based on the American College of Rheumatology criteria. Participants will be randomized into two groups: an experimental group receiving VR-based rehabilitation in addition to conventional physical therapy, and a control group receiving only conventional therapy. Both groups will undergo a 3-week intervention, consisting of 15 sessions conducted five times weekly.

The experimental group will use the Meta Quest 3 VR device for a gamified exercise program, incorporating two key modules:

Fruit Ninja VR - This module will focus on upper and lower body coordination, proprioception, and reaction time through interactive slicing motions.

PowerBeats VR - This module will emphasize endurance, knee stability, and functional coordination via rhythm-based punching and dodging activities.

Both modules are designed to engage participants in dynamic movements that promote balance, proprioception, and functional stability, tailored to address the needs of individuals with knee OA. The control group will receive conventional therapy alone, including exercises, ultrasound, and transcutaneous electrical nerve stimulation (TENS).

Outcome measures will be assessed at baseline, immediately post-intervention (3 weeks), and at follow-up (7 weeks). These include:

Pain: Visual Analog Scale (VAS) Functionality: Six-Minute Walk Test (6MWT) Disability: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Balance: Berg Balance Scale (BBS) The trial hypothesizes that the experimental group will demonstrate superior improvements in pain, functionality, disability, and balance compared to the control group. Statistical analyses will include repeated measures ANOVA to assess differences across time points and between groups.

Ethical approval has been obtained from the Umm Al-Qura University Biomedical Research Ethics Committee, and informed consent will be secured from all participants before participation. This study aims to contribute to the growing body of evidence supporting the integration of VR technologies into rehabilitation practices, particularly for musculoskeletal conditions like knee OA.

Eligibility criteria: Inclusion Criteria:

* Age: 40-64 years
* Diagnosis: Knee OA (Stages 2 or 3 based on American College of Rheumatology criteria)
* Ability to read and understand Arabic

Exclusion Criteria:

* Recent lower extremity surgery/fractures
* Other rheumatologic or cardiovascular conditions
* Visual/auditory impairments
* Dizziness or vertigo

Primary outcomes:
measure: Pain
timeFrame: From enrolment to the end of treatment at 7 weeks
measure: Function
timeFrame: From enrolment to the end of treatment at 7 weeks
measure: Disability
timeFrame: From enrolment to the end of treatment at 7 weeks
measure: Balance
timeFrame: From enrolment to the end of treatment at 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Makkah
country: Saudi Arabia
facility: Umm Al-Qura University
Study officials:
References:
citation: Kiani S, Rezaei I, Abasi S, Zakerabasali S, Yazdani A. Technical aspects of virtual augmented reality-based rehabilitation systems for musculoskeletal disorders of the lower limbs: a systematic review. BMC Musculoskelet Disord. 2023 Jan 3;24(1):4. doi: 10.1186/s12891-022-06062-6.
citation: Stanica IC, Moldoveanu F, Portelli GP, Dascalu MI, Moldoveanu A, Ristea MG. Flexible Virtual Reality System for Neurorehabilitation and Quality of Life Improvement. Sensors (Basel). 2020 Oct 23;20(21):6045. doi: 10.3390/s20216045.
citation: Blasco J, Igual-Camacho C, Blasco M, Anton-Anton V, Ortiz-Llueca L, Roig-Casasus S. The efficacy of virtual reality tools for total knee replacement rehabilitation: A systematic review. Physiother Theory Pract. 2021 Jun;37(6):682-692. doi: 10.1080/09593985.2019.1641865. Epub 2019 Jul 17.