Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06735963

Evaluating the Impact of a Meta Quest 3 Gamified VR Rehabilitation Program in Knee Osteoarthritis

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

40 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umm Al-Qura University

Mecca, 24331, Saudi Arabia

Location contact

Moayad S Subahi, PhD

CONTACT

[email protected]

+966555502738

Moayad S Subahi, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meta Quest 3 Virtual Reality

Device

Immersive virtual reality Meta Quest 3 device

Exercise

Procedure

Traditional exercise program for knee OA patients

Electrotherapy

Device

Electrotherapy including Therapeutic Ultrasound (US) and Transcutaneous Electrical Nerve Stimulation (TENS)

Primary outcomes

  1. Pain

    Time frame: From enrolment to the end of treatment at 7 weeks

    Visual Analog Scale (VAS)

  2. Function

    Time frame: From enrolment to the end of treatment at 7 weeks

    six-Minute Walk Test (6MWT)

  3. Disability

    Time frame: From enrolment to the end of treatment at 7 weeks

    Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  4. Balance

    Time frame: From enrolment to the end of treatment at 7 weeks

    Berg Balance Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Moayad S Subahi, PhD

CONTACT

[email protected]

+966555502738

Sponsors and collaborators

Lead sponsor

Umm Al-Qura University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.