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Extended Reality Rehabilitation in Parkinson's Disease

ConditionParkinson Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Ghent

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

you have a known, excessive sensitivity to motion sickness (e.g. car sickness)

you have a medication pump

you have a brain stimulator

Trial population

Parkinson's Disease

Trial design

Design model

Case-crossover

Time perspective

Cross-sectional

Treatments tested in this trial

  • Extended reality balance training

    Device

    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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Within-Subject XR (VR and MR)1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Immediately after each condition (within one study session)
2

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.

Time frame
Immediately after each condition (within one study session)
3

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.

Time frame
Immediately after each condition (within one study session)
4

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.

Time frame
During the MR and VR condition (within one study session)

Secondary outcomes

1

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.

Time frame
During the MR session
2

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

Time frame
Before the intervention
3

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

Time frame
Before the intervention
4

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

Time frame
Before the intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Ghent

Lead sponsor

University Ghent

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: