[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659416":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":44,"studyPopulation":45,"armGroups":46,"interventions":52,"overallOfficials":40,"centralContacts":40,"locations":58,"responsibleParty":89,"collaborators":91,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":40,"enrollmentInfo":104,"targetDuration":40,"studyType":107,"phases":40,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":116,"whyStopped":40,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":40},[9,13,16,19,23],{"measure":10,"description":11,"timeFrame":12},"Score on the Igroup presence questionnaire (IPQ)","The Igroup Presence Questionnaire (IPQ) is a scale for measuring the sense of presence experienced in a virtual environment. It will be used as one of the measures to identify the subjective preference during Virtual Reality (fully immersive) and Mixed Reality (real-world combined with virtual elements). This questionaire consists of 14 items where participants indicate their spatial presence, involvement or realness on a Likert scale (1-7). Max score is 98. Higher score is higher feeling of presence, immersion and engagement.","Immediately after each condition (within one study session)",{"measure":14,"description":15,"timeFrame":12},"Score on the NASA Task Load Index (Nasa-TLX)","The NASA-TLX is a questionnaire to examine the subjective workload. It contains 6 items where participants again score each item on a 7 point Likert scale. A higher score indicates more cognitive workload.",{"measure":17,"description":18,"timeFrame":12},"Score on the Virtual Reality Sickness Questionnaire","Questionnaire to document potential side effects of using extended reality (e.g. cybersickness). Participants are asked to indicate for 9 symptoms on a 4 point Likert scale if they experience side effects and how intense they are present. A higher score indicates more adverse events.",{"measure":20,"description":21,"timeFrame":22},"Hartrate (variability) during the extended reality sessions","Physiological responses during VR and MR conditions are measured continuously using a wearable device. These measures reflect autonomic nervous system activity and objective load during task performance. Differences between VR and MR conditions will be analyzed.","During the MR and VR condition (within one study session)",{"measure":24,"description":21,"timeFrame":22},"Skin conduction during the extended reality sessions",[26,30,34,37],{"measure":27,"description":28,"timeFrame":29},"Eye tracking during the extended reality task as a measure of visual function","Exploration of the relationship between visual function and subjective cognitive load scores obtained after the MR condition, to assess whether eye movement behavior contributes to perceived mental effort.","During the MR session",{"measure":31,"description":32,"timeFrame":33},"Education level","Participants will be questioned to know their highest education level. This will be used to assess if this a co-variate for the primary outcome measures","Before the intervention",{"measure":35,"description":36,"timeFrame":33},"Experience with the use of extended reality","Participants will be questioned to know if they have any experience using extended reality. This will be used to assess if this a co-variate for the primary outcome measures",{"measure":38,"description":39,"timeFrame":33},"Technological skilled","Participants will be questioned to know if they consider themselves technological skilled. This will be used to assess if this a co-variate for the primary outcome measures",null,{"allocation":40,"interventionModel":40,"interventionModelDescription":40,"primaryPurpose":40,"observationalModel":42,"timePerspective":43,"maskingInfo":40},"CASE_CROSSOVER","CROSS_SECTIONAL","Extended reality is being used increasingly within neurological rehabilitation. However, there are different forms of extended reality that can be used while wearing a head-mounted display (a VR headset). For example, sometimes the patient no longer sees the environment at all and is thus completely immersed in virtual reality (Virtual Reality), or sometimes the patient still sees part of the environment alongside the virtual reality (Mixed Reality). There are therapeutic arguments for using both forms, but to date, it is not known which is preferred for individuals with Parkinson's disease.\n\nIn a previous study (ONZ-2022-0404), a new type of therapy was tested in individuals with Parkinson's disease: visual perturbation training. This study took place in a large VR lab at Ghent University Hospital. To make this therapy accessible to more patients, this study will investigate the effect using a VR headset. Therefore, first the subjective preference in a small group of individuals with Parkinson's disease will be examined, and this study will also investigate whether there is a difference in the use of various forms of extended reality regarding a number of physical parameters (heart rate, heart rate variability, changes in skin conductance, etc.) measured in the patient using a wearable device, as well as mental load via questionnaires.\n\nThe participants will perform an exercise twice in which they have to pop balloons in a virtual world (Virtual Reality or Mixed Reality). During the exercise, participants will be secured in the Rysen, a weight-bearing system that ensures the participant cannot fall in the event of loss of balance. After each exercise, participants will complete the questionnaires on Redcap via a tablet provided by the department.\n\nOne test session lasts approximately 45 minutes.\n\nAll devices used (VR headset, Rysen weight-bearing system to guarantee patient safety, Shimmer to measure heart rate variability and skin conductance) are CE marked and are used within their scope. All tests will take place at the Rehabilitation Center of UZ Ghent. The VR headset and Rysen are devices owned by UZ Ghent. The Shimmer wearable is being made available by UGent for the duration of the study.\n\nThis information can help us with targeted follow-up research and applying for the necessary funding.","Parkinson's Disease",[47],{"label":48,"type":40,"description":49,"interventionNames":50},"Within-Subject XR (VR and MR)","Participants complete two conditions during a single study session using a head-mounted display, a Virtual Reality (fully immersive) and Mixed Reality (real-world view combined with virtual elements) tasks. The order of conditions is varied. During both conditions, participants perform a standardized balloon-popping task while seated in a weight-support system to ensure safety. Physiological responses (heart rate, heart rate variability, and skin conductance) are recorded, and subjective experience and mental load are assessed via questionnaires after each condition.",[51],"Device: Extended reality balance training",[53],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":40},"DEVICE","Extended reality balance training","Participants perform a balloon-popping task for balance training using a VR headset in two conditions: Virtual Reality (fully immersive) and Mixed Reality (real-world combined with virtual elements). The task includes visual changes to challenge how participants see and respond to their environment, including eye movements. The goal is to compare how these two formats affect mental effort and experience.",[48],[59],{"facility":60,"status":40,"city":61,"state":40,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"UZ Ghent","Ghent","9000","Belgium","BE",{"type":66,"coordinates":67},"Point",[68,69],3.71667,51.05,{"lat":69,"lon":68},[72,78,80,83,85,87],{"name":73,"role":74,"phone":75,"phoneExt":76,"email":77},"Sophie De Mits","CONTACT","09 332 12 43","+32","Sophie.DeMits@uzgent.be",{"name":73,"role":79,"phone":40,"phoneExt":40,"email":40},"PRINCIPAL_INVESTIGATOR",{"name":81,"role":82,"phone":40,"phoneExt":40,"email":40},"Lode Sabbe","SUB_INVESTIGATOR",{"name":84,"role":82,"phone":40,"phoneExt":40,"email":40},"Sam Van Damme",{"name":86,"role":82,"phone":40,"phoneExt":40,"email":40},"Femke De Backere",{"name":88,"role":82,"phone":40,"phoneExt":40,"email":40},"Anke Van Bladel",{"type":90,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[92],{"name":93,"class":6},"University Ghent","100659416","extended-reality-rehabilitation-in-parkinsons-disease-100659416",false,"NCT07863102","Extended Reality Rehabilitation in Parkinson's Disease","Effect of the Level of Immersion in Extended Reality During Rehabilitation of Individuals With Parkinson's Disease: A Pilot Study","XR-PD","Inclusion Criteria:\n\n* you have been diagnosed with Parkinson's disease\n* you can walk independently without the use of aids\n* you are not experiencing pain at the time of the test\n* you are 18 years of age or older\n* you have normal or corrected normal (glasses\u002Flenses) vision\n* you do not have a known, excessive susceptibility to motion sickness (e.g. car sickness)\n* you do not have a medication pump\n* you do not have a brain stimulator\n\nExclusion Criteria:\n\n* you have a known, excessive sensitivity to motion sickness (e.g. car sickness)\n* you have a medication pump\n* you have a brain stimulator","ALL","18 Years",{"count":105,"type":106},15,"ESTIMATED","OBSERVATIONAL","This study investigates how different types of extended reality, Virtual Reality (fully immersive) and Mixed Reality (partly real-world), can be used in rehabilitation for people with Parkinson's disease. Participants will attend a single 45-minute session at the Rehabilitation Center of UZ Ghent, where they will perform a simple balloon-popping task twice using a VR headset, once in each environment. During the exercises, they will be safely supported to prevent falls, while a wearable device measures physical responses such as heart rate and skin conductance. After each task, participants will complete short questionnaires about their experience and mental effort. The study aims to determine which type of extended reality is preferred and how each affects physical and mental responses, supporting the development of more accessible rehabilitation approaches.",[110],"Parkinson Disease",[112,113,114,115],"PD","Extended Reality","Cognitive load","XR Rehabilitation","NOT_YET_RECRUITING","2026-10-01",{"date":119,"type":120},"2026-10-07","ACTUAL",{"date":122,"type":106},"2026-10",{"date":124,"type":106},"2027-09-01",{"name":5,"class":6},1]