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

18 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

16

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.
Altri nomi:
  • Kinesix XR
  • Digital therapeutics
Comparatore attivo: 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.
Dispositivo: 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.
Altri nomi:
  • Exergioco
  • Active Arcade

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Gait Speed
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cadence
Lasso di tempo: Baseline and post-intervention (6 weeks)
Change in cadence measured using the Baiobit inertial sensor system.
Baseline and post-intervention (6 weeks)
Adherence Rate
Lasso di tempo: Throughout the 6-week intervention period
Percentage of scheduled intervention sessions completed by participants.
Throughout the 6-week intervention period
Adverse Events
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Neuro Group XR Inc.

Collaboratori

Universidad Santo Tomas

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 settembre 2025

Completamento primario (Effettivo)

27 settembre 2025

Completamento dello studio (Effettivo)

21 novembre 2025

Date di iscrizione allo studio

Primo inviato

15 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 giugno 2026

Primo Inserito (Effettivo)

22 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Neuro Group XR Inc.

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione 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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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