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Parkinson s DiseaseVR-PDNCT07659288

Comparison of Immersive and Non-Immersive Virtual Reality Rehabilitation in Parkinson's Disease

A study testing Immersive Virtual Reality and Non-Immersive Virtual Reality in people with Parkinson s Disease, run by Neuro Group XR Inc. at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Parkinson's disease commonly affects walking ability, balance, mobility, and cognitive function, increasing the risk of falls and reducing independence. Virtual reality (VR) has emerged as a promising rehabilitation tool, but the potential differences between immersive and non-immersive VR approaches remain unclear. Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Parkinson s Disease
What is being tested?
Immersive Virtual Reality and Non-Immersive Virtual Reality
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteChile
Study dates
10 Sep 2025to 21 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

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 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 45 and 75 years.
  • Diagnosis of idiopathic Parkinson's disease.
  • Hoehn and Yahr stage between 1.5 and 4.
  • Ability to walk independently or with an assistive device (cane or walker).
  • Low to moderate fall risk, defined as a Timed Up and Go (TUG) score <20 seconds.
  • Ability to provide written informed consent.

Who cannot join

  • Diagnosis of other neurological or movement disorders.
  • Severe cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score <18.
  • Severe visual impairment not correctable with lenses.
  • History of epilepsy.
  • Uncontrolled psychiatric disorders.
  • Previous deep brain stimulation.

Trial locations and contacts

1 site in 1 country.

Chile1 site
  • Escuela de Kinesiología, Facultad de Salud, Universidad Santo Tomás

    La Serena

Other trials in Chile

About this study

Official title: Differential Motor and Cognitive Responses to Two Virtual Reality-Based Rehabilitation Approaches in Parkinson's Disease: A Pilot Comparative Study

Parkinson's disease commonly affects walking ability, balance, mobility, and cognitive function, increasing the risk of falls and reducing independence. Virtual reality (VR) has emerged as a promising rehabilitation tool, but the potential differences between immersive and non-immersive VR approaches remain unclear.

This pilot randomized comparative study aims to evaluate the feasibility, safety, and preliminary effects of immersive virtual reality (IVR) and non-immersive virtual reality (NIVR) rehabilitation in individuals with Parkinson's disease. Participants will be assigned to either an immersive VR intervention using a head-mounted display or a non-immersive VR intervention using a tablet-based exergaming platform.

Read more

Both interventions will be delivered over six weeks and will target gait, balance, mobility, motor-cognitive interaction, and functional performance. Outcomes will include gait parameters, functional mobility, freezing of gait, cognitive function, adherence, and safety.

The findings will help determine whether different VR modalities produce distinct motor and cognitive responses and will inform the design of future larger clinical trials.

Read the detailed description

Parkinson's disease is a progressive neurodegenerative disorder characterized by motor impairments such as gait dysfunction, postural instability, mobility limitations, and freezing of gait, as well as cognitive deficits affecting attention, executive function, and dual-task performance. These impairments contribute substantially to disability, fall risk, and reduced quality of life.

Virtual reality-based rehabilitation has emerged as a promising approach for delivering task-oriented, repetitive, and engaging interventions that simultaneously address motor and cognitive domains. However, immersive and non-immersive virtual reality systems differ substantially in their interaction characteristics, sensory feedback, and degree of user immersion, and their comparative effects in Parkinson's disease remain insufficiently understood.

The purpose of this pilot randomized comparative study is to evaluate the feasibility, safety, and preliminary clinical effects of immersive virtual reality (IVR) compared with non-immersive virtual reality (NIVR) rehabilitation in individuals with idiopathic Parkinson's disease.

Participants diagnosed with Parkinson's disease will be allocated to one of two intervention groups. The IVR group will receive rehabilitation using the KINESIX XR platform delivered through a head-mounted display with real-time motion tracking and three-dimensional interactive environments. The NIVR group will receive rehabilitation using the Active Arcade exergaming platform delivered on a tablet device. Both interventions will be supervised and delivered over a six-week period, consisting of ten treatment sessions in addition to baseline and post-intervention assessments.

Outcome measures will include spatiotemporal gait parameters, functional mobility, dual-task performance, turning ability, freezing of gait symptoms, cognitive function, adherence to treatment, and safety outcomes. Assessments will be conducted at baseline and immediately following completion of the intervention program.

The results of this study are expected to provide preliminary evidence regarding the differential motor and cognitive responses associated with immersive and non-immersive virtual reality rehabilitation and will support the development of future adequately powered clinical trials in Parkinson's disease rehabilitation.

Being tested
Immersive Virtual Reality, Non-Immersive Virtual Reality
Keywords
parkinson disease, virtual reality, Neurorehabilitation, Gait Disorders, Neurologic, Postural Balance, Cognitive Function
Medical subject headings
Parkinson Disease, Gait Disorders, Neurologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immersive Virtual RealityDevice

    Also called Kinesix XR, Digital therapeutics

    Participants received immersive virtual reality-based rehabilitation using the KINESIX XR platform delivered through a Meta Quest 3 head-mounted display. The system provided interactive motor and cognitive training through immersive virtual environments, with real-time visual and auditory feedback. Participants interacted with virtual tasks using natural body movements and hand tracking. The intervention targeted gait, balance, mobility, motor performance, and cognitive function. Treatment consisted of ten supervised sessions delivered over six weeks.

  • Non-Immersive Virtual RealityDevice

    Also called Active Arcade, Exergame

    Participants received non-immersive virtual reality-based rehabilitation using the Active Arcade exergaming platform delivered on a tablet device. The intervention included interactive game-based exercises designed to promote physical activity, mobility, balance, coordination, and cognitive engagement through screen-based interaction. Treatment consisted of ten supervised sessions delivered over six weeks.

Study groups in NCT07659288
Study groupRoleWhat they receive
Immersive Virtual Reality RehabilitationExperimentalParticipants received immersive virtual reality-based rehabilitation using the KINESIX XR platform delivered through a head-mounted display. The intervention consisted of supervised sessions targeting gait, balance, mobility, motor function, and cognitive performance. Participants completed ten intervention sessions over a six-week period.
Receives: Device: Immersive Virtual Reality
Non-Immersive Virtual Reality RehabilitationActive comparatorParticipants received non-immersive virtual reality-based rehabilitation using the Active Arcade exergaming platform delivered on a tablet device. The intervention consisted of supervised sessions targeting gait, balance, mobility, motor function, and cognitive performance. Participants completed ten intervention sessions over a six-week period.
Receives: Device: Non-Immersive Virtual Reality

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gait Speed

    Change in gait speed measured using the Baiobit wearable inertial sensor system (Rivelo, Italy) during walking assessments.

    Measured: Baseline and post-intervention (6 weeks)

Secondary outcomes (9)
  1. Step Lenght

    Change in step length measured using the Baiobit inertial sensor system.

    Measured: Baseline and post-intervention (6 weeks)

  2. Cadence

    Change in cadence measured using the Baiobit inertial sensor system.

    Measured: Baseline and post-intervention (6 weeks)

  3. Timed Up and Go Test

    Timed Up and Go Test (TUG): Change in time required to stand up from a chair, walk 3 meters, turn, return, and sit down. Scores range from 0 seconds to no defined maximum; lower values indicate better functional mobility and lower fall risk.

    Measured: Baseline and post-intervention (6 weeks)

  4. Rapid Turn Test

    Rapid Turn Test (RTT): Change in dynamic balance and turning ability assessed using the Rapid Turn Test. The test evaluates the time (seconds) and number of steps required to complete a full 360-degree turn. Lower values indicate better dynamic balance and turning performance. No defined minimum or maximum values exist.

    Measured: Baseline and post-intervention (6 weeks)

  5. Freezing of Gait Questionnaire

    Freezing of Gait Questionnaire (FOG-Q): Change in freezing-related symptoms measured using the Freezing of Gait Questionnaire. Total score ranges from 0 to 24 points, with higher scores indicating more severe freezing symptoms.

    Measured: Baseline and post-intervention (6 weeks)

  6. Montreal Cognitive Assessment

    Montreal Cognitive Assessment (MoCA): Change in cognitive function measured using the Montreal Cognitive Assessment. Total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance.

    Measured: Baseline and post-intervention (6 weeks)

  7. Dual-Task Timed Up and Go

    Dual-Task Timed Up and Go Test: Change in time required to complete the Timed Up and Go test while performing a concurrent cognitive task. Scores range from 0 seconds to no defined maximum; lower values indicate better dual-task performance and reduced motor-cognitive interference.

    Measured: Baseline and post-intervention (6 weeks)

  8. Adherence Rate

    Percentage of scheduled intervention sessions completed by participants.

    Measured: Throughout the 6-week intervention period

  9. Adverse Events

    Number and characteristics of adverse events recorded during the intervention period.

    Measured: Throughout the 6-week intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2026
  2. Study start10 Sep 2025
  3. Primary completion27 Sep 2025
  4. Study completion21 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants with Parkinson's disease were randomized to one of two parallel intervention groups: immersive virtual reality rehabilitation or non-immersive virtual reality rehabilitation. Both groups received supervised rehabilitation over a six-week period and underwent identical baseline and post-intervention assessments. Participants remained in their assigned intervention group throughout the study.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07659288
Sponsor's protocol ID
Neuro Group XR Inc.
Acronym
VR-PD
Status last verified
Jun 2026
First submitted
15 Jun 2026
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the results reported in this study will be available upon reasonable request to the corresponding author.

Publications

  • Solares L, Llana T, García-Navarra S, Mendez M. Advances in Virtual Reality-Based Physical Rehabilitation for Neurodegenerative Diseases: A Systematic Review. Applied Sciences (Switzerland). 2025;15(18). doi:10.3390/app15189903

  • Georgiev DD, Georgieva I, Gong Z, Nanjappan V, Georgiev GV. Virtual Reality for Neurorehabilitation and Cognitive Enhancement. Brain Sci. 2021 Feb 11;11(2):221. doi: 10.3390/brainsci11020221.

    PubMed 33670277
  • Peralta-Wieland B, Vasquez-Torres R, Maldonado-Diaz M, Yoma M. Immersive Virtual Reality-Based Rehabilitation for Upper Limb Recovery in Acute and Subacute Stroke Patients: A Feasibility Study. Physiother Res Int. 2026 Jan;31(1):e70151. doi: 10.1002/pri.70151.

    PubMed 41416487
  • Radder DLM, Ligia Silva de Lima A, Domingos J, Keus SHJ, van Nimwegen M, Bloem BR, de Vries NM. Physiotherapy in Parkinson's Disease: A Meta-Analysis of Present Treatment Modalities. Neurorehabil Neural Repair. 2020 Oct;34(10):871-880. doi: 10.1177/1545968320952799. Epub 2020 Sep 11.

    PubMed 32917125
  • Counsell C, Giuntoli C, Khan QI, Maple-Grodem J, Macleod AD. The incidence, baseline predictors, and outcomes of dementia in an incident cohort of Parkinson's disease and controls. J Neurol. 2022 Aug;269(8):4288-4298. doi: 10.1007/s00415-022-11058-2. Epub 2022 Mar 21.

    PubMed 35307754
  • Lima DP, de-Almeida SB, Bonfadini JC, Carneiro AHS, de Luna JRG, de Alencar MS, Viana-Junior AB, Rodrigues PGB, Pereira IS, Roriz-Filho JS, Sobreira-Neto MA, Braga-Neto P. Falls in Parkinson's disease: the impact of disease progression, treatment, and motor complications. Dement Neuropsychol. 2022 Apr-Jun;16(2):153-161. doi: 10.1590/1980-5764-DN-2021-0019. Epub 2022 Apr 29.

    PubMed 35720647

Questions about this trial

What is this clinical trial studying?

A study testing Immersive Virtual Reality and Non-Immersive Virtual Reality in people with Parkinson s Disease, run by Neuro Group XR Inc. at 1 site in Chile.

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 6 inclusion and 6 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: finished, as of the sponsor's last update on 23 Jun 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 Chile. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait Speed (time frame: Baseline and post-intervention (6 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07659288, which also lists 6 linked publications.

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 23 Jun 2026.

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