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

NCT07659288 | Completed

• 1 other identifier: Neuro Group XR Inc.
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Parkinson s Disease

Keywords

parkinson disease; virtual reality; Neurorehabilitation; Gait Disorders, Neurologic; Postural Balance; Cognitive Function

Outcome Measures

Primary Outcomes (1)

• Gait Speed

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

  Baseline and post-intervention (6 weeks)

Secondary Outcomes (9)

• Step Lenght

  Baseline and post-intervention (6 weeks)

• Cadence

  Baseline and post-intervention (6 weeks)

• Timed Up and Go Test

  Baseline and post-intervention (6 weeks)

• Rapid Turn Test

  Baseline and post-intervention (6 weeks)

• Freezing of Gait Questionnaire

  Baseline and post-intervention (6 weeks)

Study Arms (2)

Immersive Virtual Reality Rehabilitation

EXPERIMENTAL

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

Non-Immersive Virtual Reality Rehabilitation

ACTIVE COMPARATOR

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

Interventions

Immersive Virtual Reality DEVICE

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.

Also known as: Kinesix XR, Digital therapeutics

Immersive Virtual Reality Rehabilitation

Non-Immersive Virtual Reality DEVICE

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.

Also known as: Active Arcade, Exergame

Non-Immersive Virtual Reality Rehabilitation

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuro Group XR Inc.: lead
• Universidad Santo Tomas: collaborator

Study Sites (1)

Escuela de Kinesiología, Facultad de Salud, Universidad Santo Tomás

La Serena, Chile

Location

Related Publications (6)

• 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

  RESULT

• 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.

  PMID: 33670277 RESULT

• 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.

  PMID: 41416487 RESULT

• 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.

  PMID: 32917125 RESULT

• 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.

  PMID: 35307754 RESULT

• 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.

  PMID: 35720647 RESULT

Related Links

• website of the device used for the intervention
• website of the device used for the intervention

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Valeria F Gálvez, MSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments were performed by an evaluator who was blinded to group allocation. Participants and treating therapists were aware of the intervention received due to the nature of the virtual reality interventions, but the assessor responsible for baseline and post-intervention evaluations was not informed of treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start: September 10, 2025
• Primary Completion: September 27, 2025
• Study Completion: November 21, 2025
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter.
• 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.

Locations

CL (1)