An interventional study of Meta Quest 3 Virtual Reality and Exercise in Knee Osteoarthristis, sponsored by Umm Al-Qura University. Not yet recruiting at 1 site in Saudi Arabia. Open to participants aged 40 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Umm Al-Qura University · Not applicable, Interventional, and Treatment
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.
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.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 90 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Umm Al-Qura University is the lead sponsor of 47 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
The control group will receive conventional therapy alone, including exercises, ultrasound, and transcutaneous electrical nerve stimulation (TENS).
Procedure: Exercise · Device: Electrotherapy
Experimental group receiving VR-based rehabilitation in addition to conventional physical therapy,
Device: Meta Quest 3 Virtual Reality · Procedure: Exercise · Device: Electrotherapy
Immersive virtual reality Meta Quest 3 device
Traditional exercise program for knee OA patients
Electrotherapy including Therapeutic Ultrasound (US) and Transcutaneous Electrical Nerve Stimulation (TENS)
Pain
Visual Analog Scale (VAS)
Time frame: From enrolment to the end of treatment at 7 weeks
Function
six-Minute Walk Test (6MWT)
Time frame: From enrolment to the end of treatment at 7 weeks
Disability
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: From enrolment to the end of treatment at 7 weeks
Balance
Berg Balance Scale
Time frame: From enrolment to the end of treatment at 7 weeks
Plan to share: No
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Umm Al-Qura University