Knee OsteoarthristisNCT06735963
Evaluating the Impact of a Meta Quest 3 Gamified VR Rehabilitation Program in Knee Osteoarthritis
A study testing Meta Quest 3 Virtual Reality, Exercise and Electrotherapy in people with Knee Osteoarthristis, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Meta Quest 3 Virtual Reality, Exercise and Electrotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 11 Dec 2024to 20 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 40-64 years
- Diagnosis: Knee OA (Stages 2 or 3 based on American College of Rheumatology criteria)
- Ability to read and understand Arabic
Who cannot join
- Recent lower extremity surgery/fractures
- Other rheumatologic or cardiovascular conditions
- Visual/auditory impairments
- Dizziness or vertigo
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
Umm Al-Qura University
Mecca, 24331
Moayad S Subahi, PhD, +966555502738, mssubahi@uqu.edu.sa
Moayad S Subahi, PhD
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Knee Osteoarthristis
- Being tested
- Meta Quest 3 Virtual Reality, Exercise, Electrotherapy
- Keywords
- osteoarthritis, virtual reality, game, rehabilitation
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meta Quest 3 Virtual RealityDevice
Immersive virtual reality Meta Quest 3 device
ExerciseProcedure or surgery
Traditional exercise program for knee OA patients
ElectrotherapyDevice
Electrotherapy including Therapeutic Ultrasound (US) and Transcutaneous Electrical Nerve Stimulation (TENS)
| Study group | Role | What they receive |
|---|---|---|
| conventional therapy control group | Active comparator | The control group will receive conventional therapy alone, including exercises, ultrasound, and transcutaneous electrical nerve stimulation (TENS). Receives: Procedure: Exercise; Device: Electrotherapy |
| Experimental VR-based Group | Experimental | Experimental group receiving VR-based rehabilitation in addition to conventional physical therapy, Receives: Device: Meta Quest 3 Virtual Reality; Procedure: Exercise; Device: Electrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Visual Analog Scale (VAS)
Measured: From enrolment to the end of treatment at 7 weeks
Function
six-Minute Walk Test (6MWT)
Measured: From enrolment to the end of treatment at 7 weeks
Disability
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Measured: From enrolment to the end of treatment at 7 weeks
Balance
Berg Balance Scale
Measured: From enrolment to the end of treatment at 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start11 Dec 2024 (estimated)
- Primary completion20 Mar 2025 (estimated)
- Study completion20 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moayad Subahi, Umm Al-Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735963
- Sponsor's protocol ID
- HAPO-02-K-012-2024-12-2379
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36597077Stanica 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.
PubMed 33114272Blasco 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.
PubMed 31313607
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06735963
- Acronym / sponsor ID
- HAPO-02-K-012-2024-12-2379
- Conditions
- Knee Osteoarthristis
- Keywords
- osteoarthritis, virtual reality, game, rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 11 Dec 2024 (estimated)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 20 Jul 2025 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional therapy control group | Active comparator | Procedure: Exercise, Device: ElectrotherapyThe control group will receive conventional therapy alone, including exercises, ultrasound, and transcutaneous electrical nerve stimulation (TENS). |
| Experimental VR-based Group | Experimental | Device: Meta Quest 3 Virtual Reality, Procedure: Exercise, Device: ElectrotherapyExperimental group receiving VR-based rehabilitation in addition to conventional physical therapy, |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 40-64 years
- Diagnosis: Knee OA (Stages 2 or 3 based on American College of Rheumatology criteria)
- Ability to read and understand Arabic
Key exclusion criteria (4 listed)
- Recent lower extremity surgery/fractures
- Other rheumatologic or cardiovascular conditions
- Visual/auditory impairments
- Dizziness or vertigo
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meta Quest 3 Virtual RealityImmersive virtual reality Meta Quest 3 device | Device | Experimental VR-based Group |
| ExerciseTraditional exercise program for knee OA patients | Procedure or surgery | Experimental VR-based Group, conventional therapy control group |
| ElectrotherapyElectrotherapy including Therapeutic Ultrasound (US) and Transcutaneous Electrical Nerve Stimulation (TENS) | Device | Experimental VR-based Group, conventional therapy control group |
Primary outcome
Pain
Time frame: From enrolment to the end of treatment at 7 weeks
Visual Analog Scale (VAS)
Function
Time frame: From enrolment to the end of treatment at 7 weeks
six-Minute Walk Test (6MWT)
Disability
Time frame: From enrolment to the end of treatment at 7 weeks
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Balance
Time frame: From enrolment to the end of treatment at 7 weeks
Berg Balance Scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Background: PubMed 36597077Kiani 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.
- Background: PubMed 33114272Stanica 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.
- Background: PubMed 31313607Blasco 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meta Quest 3 Virtual Reality, Exercise and Electrotherapy in people with Knee Osteoarthristis, run by Umm Al-Qura University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moayad S Subahi, PhD (+966555502738, mssubahi@uqu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: From enrolment to the end of treatment at 7 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06735963, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.