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

December 11, 2024 updated by: Moayad Subahi, Umm Al-Qura University

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Saudi Arabia
      • Makkah, Saudi Arabia, 24331
        • Umm Al-Qura University
        • Contact:
        • Contact:
          • Moayad S Subahi, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional therapy control group
The control group will receive conventional therapy alone, including exercises, ultrasound, and transcutaneous electrical nerve stimulation (TENS).
Procedure: Exercise
Traditional exercise program for knee OA patients
Device: Electrotherapy
Electrotherapy including Therapeutic Ultrasound (US) and Transcutaneous Electrical Nerve Stimulation (TENS)
Experimental: Experimental VR-based Group
Experimental group receiving VR-based rehabilitation in addition to conventional physical therapy,
Procedure: Exercise
Traditional exercise program for knee OA patients
Device: Electrotherapy
Electrotherapy including Therapeutic Ultrasound (US) and Transcutaneous Electrical Nerve Stimulation (TENS)
Device: Meta Quest 3 Virtual Reality
Immersive virtual reality Meta Quest 3 device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: From enrolment to the end of treatment at 7 weeks
Visual Analog Scale (VAS)
From enrolment to the end of treatment at 7 weeks
Function
Time Frame: From enrolment to the end of treatment at 7 weeks
six-Minute Walk Test (6MWT)
From enrolment to the end of treatment at 7 weeks
Disability
Time Frame: From enrolment to the end of treatment at 7 weeks
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
From enrolment to the end of treatment at 7 weeks
Balance
Time Frame: From enrolment to the end of treatment at 7 weeks
Berg Balance Scale
From enrolment to the end of treatment at 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umm Al-Qura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 11, 2024

Primary Completion (Estimated)

March 20, 2025

Study Completion (Estimated)

July 20, 2025

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAPO-02-K-012-2024-12-2379

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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