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

NCT06735963 | Not Yet Recruiting

• 1 other identifier: HAPO-02-K-012-2024-12-2379
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthristis

Keywords

osteoarthritis; virtual reality; game; rehabilitation

Outcome Measures

Primary Outcomes (4)

• Pain

  Visual Analog Scale (VAS)

  From enrolment to the end of treatment at 7 weeks

• Function

  six-Minute Walk Test (6MWT)

  From enrolment to the end of treatment at 7 weeks

• Disability

  Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  From enrolment to the end of treatment at 7 weeks

• Balance

  Berg Balance Scale

  From enrolment to the end of treatment at 7 weeks

Study Arms (2)

conventional therapy control group

ACTIVE COMPARATOR

The control group will receive conventional therapy alone, including exercises, ultrasound, and transcutaneous electrical nerve stimulation (TENS).

Procedure: Exercise; Device: Electrotherapy

Experimental VR-based Group

EXPERIMENTAL

Experimental group receiving VR-based rehabilitation in addition to conventional physical therapy,

Device: Meta Quest 3 Virtual Reality; Procedure: Exercise; Device: Electrotherapy

Interventions

Meta Quest 3 Virtual Reality DEVICE

Immersive virtual reality Meta Quest 3 device

Experimental VR-based Group

Exercise PROCEDURE

Traditional exercise program for knee OA patients

Experimental VR-based Group; conventional therapy control group

Electrotherapy DEVICE

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

Experimental VR-based Group; conventional therapy control group

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Umm Al-Qura University

Mecca, 24331, Saudi Arabia

Location

Related Publications (3)

• 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.

  PMID: 36597077 BACKGROUND

• 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.

  PMID: 33114272 BACKGROUND

• 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.

  PMID: 31313607 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Exercise; Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Moayad S Subahi, PhD

CONTACT

+966555502738; mssubahi@uqu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: December 11, 2024
• Primary Completion: March 20, 2025
• Study Completion: July 20, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)