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| Name | Class |
|---|---|
| Universidad Santo Tomas | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Step Lenght | Change in step length measured using the Baiobit inertial sensor system. | Baseline and post-intervention (6 weeks) |
| Cadence | Change in cadence measured using the Baiobit inertial sensor system. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valeria F Gálvez, MSc | Escuela de KinesiologÃa, Facultad de Salud, Universidad Santo Tomás, La Serena, Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Escuela de KinesiologÃa, Facultad de Salud, Universidad Santo Tomás | La Serena | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Solares L, Llana T, GarcÃa-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 | ||
| 33670277 | 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. | |
| 41416487 |
| Label | URL |
|---|---|
| website of the device used for the intervention | View source |
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De-identified individual participant data underlying the results reported in this study will be available upon reasonable request to the corresponding author.
Data will be available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter.
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.
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
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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.
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| 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. |
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| Baseline and post-intervention (6 weeks) |
| Timed Up and Go Test | 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 | 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 | 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 | 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 | 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) |
| Adherence Rate | Percentage of scheduled intervention sessions completed by participants. | Throughout the 6-week intervention period |
| Adverse Events | Number and characteristics of adverse events recorded during the intervention period. | Throughout the 6-week intervention period |
| 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. |
| 32917125 | 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. |
| 35307754 | 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. |
| 35720647 | 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. |
| website of the device used for the intervention | View source |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |