Parkinson DiseaseXR-PDNCT07863102
Extended Reality Rehabilitation in Parkinson's Disease
An observational study of Parkinson Disease, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Extended reality balance training
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2026to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's Disease
Who may be able to join
- you have been diagnosed with Parkinson's disease
- you can walk independently without the use of aids
- you are not experiencing pain at the time of the test
- you are 18 years of age or older
- you have normal or corrected normal (glasses/lenses) vision
- you do not have a known, excessive susceptibility to motion sickness (e.g. car sickness)
- you do not have a medication pump
- you do not have a brain stimulator
Who cannot join
- you have a known, excessive sensitivity to motion sickness (e.g. car sickness)
- you have a medication pump
- you have a brain stimulator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
UZ Ghent
Ghent, 9000
Sophie De Mits, 09 332 12 43 ext. +32, Sophie.DeMits@uzgent.be
Sophie De Mits
About this study
Official title: Effect of the Level of Immersion in Extended Reality During Rehabilitation of Individuals With Parkinson's Disease: A Pilot Study
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.
Read the detailed description
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.
In 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.
The 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.
One test session lasts approximately 45 minutes.
All 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.
This information can help us with targeted follow-up research and applying for the necessary funding.
- Conditions
- Parkinson Disease
- Being tested
- Extended reality balance training
- Keywords
- PD, Extended Reality, Cognitive load, XR Rehabilitation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended reality balance trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Extended reality balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after each condition (within one study session)
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.
Measured: Immediately after each condition (within one study session)
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.
Measured: Immediately after each condition (within one study session)
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.
Measured: During the MR and VR condition (within one study session)
Skin conduction 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.
Measured: During the MR and VR condition (within one study session)
Secondary outcomes (4)
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.
Measured: During the MR session
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
Measured: Before the intervention
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
Measured: Before the intervention
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
Measured: Before the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863102
- Sponsor's protocol ID
- ONZ-2026-0059
- Other IDs
- ID 27240
- Acronym
- XR-PD
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Level of Immersion in Extended Reality During Rehabilitation of Individuals With Parkinson's Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT07863102
- Acronym / sponsor ID
- XR-PD / ONZ-2026-0059
- Conditions
- Parkinson Disease
- Keywords
- PD, Extended Reality, Cognitive load, XR Rehabilitation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
In 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.
The 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.
One test session lasts approximately 45 minutes.
All 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.
This information can help us with targeted follow-up research and applying for the necessary funding.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Within-Subject XR (VR and MR) | – | Device: Extended reality balance trainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's Disease
Key inclusion criteria (8 listed)
- you have been diagnosed with Parkinson's disease
- you can walk independently without the use of aids
- you are not experiencing pain at the time of the test
- you are 18 years of age or older
- you have normal or corrected normal (glasses/lenses) vision
Key exclusion criteria (3 listed)
- you have a known, excessive sensitivity to motion sickness (e.g. car sickness)
- you have a medication pump
- you have a brain stimulator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended reality balance trainingParticipants 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. | Device | Within-Subject XR (VR and MR) |
Primary outcome
Score on the Igroup presence questionnaire (IPQ)
Time frame: Immediately after each condition (within one study session)
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.
Score on the NASA Task Load Index (Nasa-TLX)
Time frame: Immediately after each condition (within one study session)
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.
Score on the Virtual Reality Sickness Questionnaire
Time frame: Immediately after each condition (within one study session)
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.
Hartrate (variability) during the extended reality sessions
Time frame: During the MR and VR condition (within one study session)
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.
Skin conduction during the extended reality sessions
Time frame: During the MR and VR condition (within one study session)
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.
4 secondary outcomes
Eye tracking during the extended reality task as a measure of visual function
Time frame: During the MR session
Education level
Time frame: Before the intervention
Experience with the use of extended reality
Time frame: Before the intervention
Technological skilled
Time frame: Before the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the Igroup presence questionnaire (IPQ) (time frame: Immediately after each condition (within one study session)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.