Cognitive-Based Balance Rehabilitation in Parkinson's Disease: Virtual Reality vs. Dual Task

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorBezmialem Vakif University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with Parkinson's Disease by a neurologist.

Hoehn & Yahr Stage I-III.

Aged between 40-80 years.

Literate and capable of performing basic mathematical calculations.

Disqualifiers

Currently participating in another exercise or drug trial.

Presence of any additional neurological disorders.

Significant musculoskeletal disorders, arthritis, or cardiovascular disease.

Uncontrolled epilepsy or severe orthostatic hypotension.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dual Task Training (DTT)

    Other intervention

    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.

  • Virtual Reality Training (VRT)

    Other intervention

    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.

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Dual Task GroupActive comparator 1 intervention
Group B: Virtual Reality GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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