Comparison of Immersive and Non-Immersive Virtual Reality Rehabilitation in Parkinson's Disease (VR-PD)
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
La Serena, Chile
- Escuela de Kinesiología, Facultad de Salud, Universidad Santo Tomás
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
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.
Andere Namen:
|
|
Aktiver Komparator: 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.
|
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.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Gait Speed
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Cadence
Zeitfenster: Baseline and post-intervention (6 weeks)
|
Change in cadence measured using the Baiobit inertial sensor system.
|
Baseline and post-intervention (6 weeks)
|
|
Adherence Rate
Zeitfenster: Throughout the 6-week intervention period
|
Percentage of scheduled intervention sessions completed by participants.
|
Throughout the 6-week intervention period
|
|
Adverse Events
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Valeria F Gálvez, MSc, Escuela de Kinesiología, Facultad de Salud, Universidad Santo Tomás, La Serena, Chile
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Synucleinopathien
- Neurologische Manifestationen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Neurodegenerative Krankheiten
- Bewegungsstörungen
- Parkinsonsche Störungen
- Erkrankungen der Basalganglien
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Parkinson Krankheit
- Gangstörungen, neurologisch
Andere Studien-ID-Nummern
- Neuro Group XR Inc.
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
IPD-Sharing-Zeitrahmen
IPD-Sharing-Zugriffskriterien
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .