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

18 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

16

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: 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.
Autres noms:
  • Kinesix XR
  • Digital therapeutics
Comparateur actif: 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.
Dispositif: 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.
Autres noms:
  • Jeu d'entraînement
  • Active Arcade

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Gait Speed
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Cadence
Délai: Baseline and post-intervention (6 weeks)
Change in cadence measured using the Baiobit inertial sensor system.
Baseline and post-intervention (6 weeks)
Adherence Rate
Délai: Throughout the 6-week intervention period
Percentage of scheduled intervention sessions completed by participants.
Throughout the 6-week intervention period
Adverse Events
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Neuro Group XR Inc.

Collaborateurs

Universidad Santo Tomas

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 septembre 2025

Achèvement primaire (Réel)

27 septembre 2025

Achèvement de l'étude (Réel)

21 novembre 2025

Dates d'inscription aux études

Première soumission

15 juin 2026

Première soumission répondant aux critères de contrôle qualité

15 juin 2026

Première publication (Réel)

22 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Neuro Group XR Inc.

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

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

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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