Escuela de Kinesiología, Facultad de Salud, Universidad Santo Tomás
La Serena, Chile
NCT Number: NCT07659288
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.
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Notify Me45 year–75 year
All sexes
Interventional
Not applicable
La Serena, Chile
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Kinesix XR, Digital therapeutics
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.
Other names: Active Arcade, Exergame
Time frame: Baseline and post-intervention (6 weeks)
Change in gait speed measured using the Baiobit wearable inertial sensor system (Rivelo, Italy) during walking assessments.
Time frame: Baseline and post-intervention (6 weeks)
Change in step length measured using the Baiobit inertial sensor system.
Time frame: Baseline and post-intervention (6 weeks)
Change in cadence measured using the Baiobit inertial sensor system.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Throughout the 6-week intervention period
Percentage of scheduled intervention sessions completed by participants.
Time frame: Throughout the 6-week intervention period
Number and characteristics of adverse events recorded during the intervention period.
Neuro Group XR Inc.
Industry
Differential Motor and Cognitive Responses to Two Virtual Reality-Based Rehabilitation Approaches in Parkinson's Disease: A Pilot Comparative Study
Acronym: VR-PD
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