[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572645":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":31,"studyPopulation":22,"armGroups":32,"interventions":46,"overallOfficials":22,"centralContacts":61,"locations":67,"responsibleParty":82,"collaborators":22,"id":86,"slug":22,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":22,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":22,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":110,"whyStopped":22,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Umm Al-Qura University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":22},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Pain","Visual Analog Scale (VAS)","From enrolment to the end of treatment at 7 weeks",{"measure":14,"description":15,"timeFrame":12},"Function","six-Minute Walk Test (6MWT)",{"measure":17,"description":18,"timeFrame":12},"Disability","Western Ontario and McMaster Universities Arthritis Index (WOMAC)",{"measure":20,"description":21,"timeFrame":12},"Balance","Berg Balance Scale",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":28,"maskingDescription":22,"whoMasked":29},"SINGLE",[30],"PARTICIPANT","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.\n\nEligible 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.\n\nThe experimental group will use the Meta Quest 3 VR device for a gamified exercise program, incorporating two key modules:\n\nFruit Ninja VR - This module will focus on upper and lower body coordination, proprioception, and reaction time through interactive slicing motions.\n\nPowerBeats VR - This module will emphasize endurance, knee stability, and functional coordination via rhythm-based punching and dodging activities.\n\nBoth 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).\n\nOutcome measures will be assessed at baseline, immediately post-intervention (3 weeks), and at follow-up (7 weeks). These include:\n\nPain: 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.\n\nEthical 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.",[33,40],{"label":34,"type":35,"description":36,"interventionNames":37},"conventional therapy control group","ACTIVE_COMPARATOR","The control group will receive conventional therapy alone, including exercises, ultrasound, and transcutaneous electrical nerve stimulation (TENS).",[38,39],"Procedure: Exercise","Device: Electrotherapy",{"label":41,"type":42,"description":43,"interventionNames":44},"Experimental VR-based Group","EXPERIMENTAL","Experimental group receiving VR-based rehabilitation in addition to conventional physical therapy,",[45,38,39],"Device: Meta Quest 3 Virtual Reality",[47,52,57],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":22},"DEVICE","Meta Quest 3 Virtual Reality","Immersive virtual reality Meta Quest 3 device",[41],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":22},"PROCEDURE","Exercise","Traditional exercise program for knee OA patients",[41,34],{"type":48,"name":58,"description":59,"armGroupLabels":60,"otherNames":22},"Electrotherapy","Electrotherapy including Therapeutic Ultrasound (US) and Transcutaneous Electrical Nerve Stimulation (TENS)",[41,34],[62],{"name":63,"role":64,"phone":65,"phoneExt":22,"email":66},"Moayad S Subahi, PhD","CONTACT","+966555502738","mssubahi@uqu.edu.sa",[68],{"facility":5,"status":22,"city":69,"state":22,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Mecca","24331","Saudi Arabia","SA",{"type":74,"coordinates":75},"Point",[76,77],39.82563,21.42664,{"lat":77,"lon":76},[80,81],{"name":63,"role":64,"phone":65,"phoneExt":22,"email":66},{"name":63,"role":64,"phone":22,"phoneExt":22,"email":22},{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Moayad Subahi","assistant professor","100572645",false,"NCT06735963","Evaluating the Impact of a Meta Quest 3 Gamified VR Rehabilitation Program in Knee Osteoarthritis","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","Inclusion Criteria:\n\n* Age: 40-64 years\n* Diagnosis: Knee OA (Stages 2 or 3 based on American College of Rheumatology criteria)\n* Ability to read and understand Arabic\n\nExclusion Criteria:\n\n* Recent lower extremity surgery\u002Ffractures\n* Other rheumatologic or cardiovascular conditions\n* Visual\u002Fauditory impairments\n* Dizziness or vertigo",true,"ALL","40 Years","64 Years",{"count":97,"type":98},90,"ESTIMATED","INTERVENTIONAL",[101],"NA","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:\n\nCan 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.\n\nParticipants will:\n\nUndergo either VR-based rehabilitation combined with conventional therapy or conventional therapy alone.\n\nComplete assessments at three time points (baseline, 3 weeks, and 7 weeks) using measures such as pain scales, disability indices, and balance tests.",[104],"Knee Osteoarthristis",[106,107,108,109],"osteoarthritis","virtual reality","game","rehabilitation","NOT_YET_RECRUITING","2024-12-11",{"date":113,"type":114},"2024-12-16","ACTUAL",{"date":111,"type":98},{"date":117,"type":98},"2025-07-20",{"name":5,"class":6},1]