Parkinson s Disease
Conditions
Keywords
parkinson disease, virtual reality, Neurorehabilitation, Gait Disorders, Neurologic, Postural Balance, Cognitive Function
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.
Detailed description
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.
Interventions
DEVICEImmersive 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.
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.
Sponsors
Neuro Group XR Inc.
Universidad Santo Tomas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait Speed | Baseline and post-intervention (6 weeks) | Change in gait speed measured using the Baiobit wearable inertial sensor system (Rivelo, Italy) during walking assessments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Step Lenght | Baseline and post-intervention (6 weeks) | Change in step length measured using the Baiobit inertial sensor system. |
| Cadence | Baseline and post-intervention (6 weeks) | Change in cadence measured using the Baiobit inertial sensor system. |
| Timed Up and Go Test | 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. |
| Rapid Turn Test | 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. |
| Freezing of Gait Questionnaire | 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. |
| Montreal Cognitive Assessment | 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. |
| Dual-Task Timed Up and Go | 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. |
| Adherence Rate | Throughout the 6-week intervention period | Percentage of scheduled intervention sessions completed by participants. |
| Adverse Events | Throughout the 6-week intervention period | Number and characteristics of adverse events recorded during the intervention period. |
Countries
Chile
Contacts
PRINCIPAL_INVESTIGATORValeria F Gálvez, MSc
Escuela de Kinesiología, Facultad de Salud, Universidad Santo Tomás, La Serena, Chile
Outcome results
None listed