This prospective, randomized, single-blind, controlled clinical trial aims to evaluate and compare the efficacy of cognitive-based balance rehabilitation delivered via immersive Virtual Reality (VR) versus traditional Dual-Task Training (DTT) on balance, gait, cognitive functions, and quality of life in patients with Parkinson's Disease (PD). Postural instability and cognitive decline are hallmark features of progressive PD that significantly elevate fall risks and compromise daily independence, yet conventional pharmacological therapies offer limited effectiveness in restoring complex postural control. Given that motor and cognitive processes are intrinsically linked, this study addresses a critical gap in neurorehabilitation by investigating two contemporary modalities designed to challenge these systems simultaneously. A total of 34 participants diagnosed with PD (aged 40-80 years, Hoehn and Yahr stages I-III) will be randomly allocated to either the Dual-Task Group (DTG), receiving structured therapeutic exercises integrated with sequential cognitive tasks, or the Virtual Reality Group (VRG), engaging in an immersive balance program utilizing the Oculus Quest 2® headset with the FIT-XR application. Both groups will undergo an identical intervention protocol consisting of 45-minute supervised sessions, conducted twice weekly for 8 consecutive weeks during their pharmacological "on" phase. Standardized assessments will be performed by a blinded clinician at baseline and post-intervention (Week 8). The primary outcome measures will be dynamic balance and gait assessed through the Mini-Balance Evaluations Systems Test (Mini-BESTest) alongside global cognitive performance measured via the Montreal Cognitive Assessment (MoCA). Secondary outcomes will encompass objective posturographic indices using the Biodex Balance System, motor severity via the Unified Parkinson's Disease Rating Scale (UPDRS-III), freezing of gait, health-related quality of life, global perceived improvement, and potential cyber-sickness symptoms monitored through the Virtual Reality Sickness Questionnaire (VRSQ) to comprehensively determine the safety and comparative therapeutic value of these interventions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
34
A supervised physical therapy program consisting of motor balance and postural control exercises executed simultaneously with secondary cognitive tasks. The physical component includes progressive static and dynamic balance training, functional gait training, and coordination exercises. The concurrent cognitive tasks involve backward counting, mental arithmetic, and working memory retrieval. The intervention is delivered in 45-minute sessions, twice a week for 8 weeks (16 sessions total) by a certified physiotherapist.
An immersive virtual reality rehabilitation program utilizing the Oculus Quest 3® VR headset. Participants engage in motion-based exercises within the clinically validated FIT-XR software application, specifically targeting multi-directional reaching, stepping, upper and lower limb coordination, and dynamic weight shifting. The exercise intensity, session duration (45 minutes), and frequency (twice weekly for 8 weeks, 16 sessions total) are tightly matched to the Dual Task Group. All sessions are fully supervised by a physiotherapist with standard safety measures.
Mini-Balance Evaluations Systems Test
A 14-item clinical rating scale specifically focused on dynamic gait and postural control across four domains: anticipatory postural adjustments, reactive postural responses, sensory orientation, and dynamic gait. Each item is scored on a scale from 0 (unable to perform) to 2 (normal performance). The total score ranges from 0 to 28, where higher scores indicate better dynamic balance and superior postural performance.
Time frame: Baseline and Week 8
Montreal Cognitive Assessment
A 30-point screening instrument designed to detect mild cognitive impairment and dementia by evaluating short-term memory, visuospatial abilities, executive function, language, attention, concentration, working memory, and orientation. The total score ranges from 0 to 30, with higher scores indicating better global cognitive function.
Time frame: Baseline and Week 8
Biodex Balance System
Postural stability (anterior-posterior stability index, mediolateral stability index, general stability index), fall risk index, and limits of stability will be assessed using the Biodex Balance System. Higher scores on stability indices indicate poorer postural stability, while higher scores on limits of stability indicate better postural control.
Time frame: Baseline and Week 8
Unified Parkinson's Disease Rating Scale - Part III (Motor Examination)
A comprehensive clinical rating scale used to evaluate the severity of motor symptoms in Parkinson's disease. Part III involves the objective motor examination. Each item is scored from 0 (unaffected) to 4 (most severely affected), yielding a total score ranging from 0 to 108. Higher scores indicate greater disease severity and more pronounced motor impairment.
Time frame: Baseline and Week 8
Parkinson's Disease Questionnaire-39
A 39-item self-administered, disease-specific health status instrument evaluating quality of life across 8 dimensions. Each item is scored on a scale from 0 (never) to 4 (always). Individual dimension scores and the global index are standardized to range from 0 to 100. Higher scores indicate worse quality of life (more frequent difficulties), while lower scores reflect better health status.
Time frame: Baseline and Week 8
Freezing of Gait Questionnaire
A 6-item self-report questionnaire designed to evaluate the severity of freezing of gait and its impact on walking performance. It includes 4 items on freezing severity and 2 items on general walking difficulty, with each item scored from 0 to 4. The total score ranges from 0 to 24, where higher scores indicate more severe freezing of gait and a greater negative impact on gait performance.
Time frame: Baseline and Week 8
Global Rating of Change Scale
A 5-point Likert scale used to measure participants' subjective perception of overall health change and treatment satisfaction over the course of the study. Total scores range from -2 to +2, where -2 represents "much worse", 0 represents "the same", and +2 represents "much better". Higher scores indicate greater perceived improvement and higher treatment satisfaction.
Time frame: Post-intervention (Week 8)
Virtual Reality Sickness Questionnaire
A 9-item self-report questionnaire assessing general oculomotor discomfort and disorientation following the virtual reality intervention. Items are scored using a 4-point Likert scale from 0 (none) to 3 (severe). The total score ranges from 0 to 27, where higher scores indicate worse and more severe cyber-sickness symptoms. This measure is evaluated only for the Virtual Reality Group.
Time frame: Post-intervention (Week 8)
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