Comparison of Immersive and Non-Immersive Virtual Reality Rehabilitation in Parkinson's Disease (VR-PD)

June 18, 2026 updated by: Neuro Group XR Inc.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • La Serena, Chile
        • Escuela de Kinesiología, Facultad de Salud, Universidad Santo Tomás

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immersive Virtual Reality Rehabilitation
Participants 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.
Device: Immersive Virtual Reality
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.
Other Names:
  • Kinesix XR
  • Digital therapeutics
Active Comparator: Non-Immersive Virtual Reality Rehabilitation
Participants 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.
Device: Non-Immersive Virtual Reality
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.
Other Names:
  • Exergame
  • Active Arcade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait Speed
Time Frame: Baseline and post-intervention (6 weeks)
Change in gait speed measured using the Baiobit wearable inertial sensor system (Rivelo, Italy) during walking assessments.
Baseline and post-intervention (6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cadence
Time Frame: Baseline and post-intervention (6 weeks)
Change in cadence measured using the Baiobit inertial sensor system.
Baseline and post-intervention (6 weeks)
Adherence Rate
Time Frame: Throughout the 6-week intervention period
Percentage of scheduled intervention sessions completed by participants.
Throughout the 6-week intervention period
Adverse Events
Time Frame: Throughout the 6-week intervention period
Number and characteristics of adverse events recorded during the intervention period.
Throughout the 6-week intervention period
Step Lenght
Time Frame: Baseline and post-intervention (6 weeks)
Change in step length measured using the Baiobit inertial sensor system.
Baseline and post-intervention (6 weeks)
Timed Up and Go Test
Time Frame: Baseline and post-intervention (6 weeks)
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.
Baseline and post-intervention (6 weeks)
Rapid Turn Test
Time Frame: Baseline and post-intervention (6 weeks)
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.
Baseline and post-intervention (6 weeks)
Freezing of Gait Questionnaire
Time Frame: Baseline and post-intervention (6 weeks)
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.
Baseline and post-intervention (6 weeks)
Montreal Cognitive Assessment
Time Frame: Baseline and post-intervention (6 weeks)
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.
Baseline and post-intervention (6 weeks)
Dual-Task Timed Up and Go
Time Frame: Baseline and post-intervention (6 weeks)
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.
Baseline and post-intervention (6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuro Group XR Inc.

Collaborators

Universidad Santo Tomas

Investigators

  • Principal Investigator: Valeria F Gálvez, MSc, Escuela de Kinesiología, Facultad de Salud, Universidad Santo Tomás, La Serena, Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2025

Primary Completion (Actual)

September 27, 2025

Study Completion (Actual)

November 21, 2025

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neuro Group XR Inc.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported in this study will be available upon reasonable request to the corresponding author.

IPD Sharing Time Frame

Data will be available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter.

IPD Sharing Access Criteria

The data that support the findings of this study are not publicly available because they contain information that could compromise participant privacy. De-identified individual participant data may be made available to qualified researchers upon reasonable request to the corresponding author for purposes of scientific research, subject to review and approval of the proposed use and execution of an appropriate data-sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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