Cognitive-Based Balance Rehabilitation in Parkinson's Disease: Virtual Reality vs. Dual Task
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dual Task Training (DTT), Virtual Reality Training (VRT).
- Who it may be relevant to
- Registry conditions: PARKINSON DISEASE (Disorder), Parkinson Disease (PD), Parkinson s Disease, Postural Instability. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Cognitive-Based Balance Rehabilitation on Balance, Gait and Cognitive Functions in Parkinson's Disease Patients: Comparison of Virtual Reality and Dual Task
Overview
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.
Interventions
- Other Dual Task Training (DTT)
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 ce - Other Virtual Reality Training (VRT)
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 ar
Primary outcome measures
- Mini-Balance Evaluations Systems Test [Time frame: Baseline and Week 8]
Secondary outcome measures (7)
- Montreal Cognitive Assessment [Time frame: Baseline and Week 8]
- Biodex Balance System [Time frame: Baseline and Week 8]
- Unified Parkinson's Disease Rating Scale - Part III (Motor Examination) [Time frame: Baseline and Week 8]
- Parkinson's Disease Questionnaire-39 [Time frame: Baseline and Week 8]
- Freezing of Gait Questionnaire [Time frame: Baseline and Week 8]
- Global Rating of Change Scale [Time frame: Post-intervention (Week 8)]
- Virtual Reality Sickness Questionnaire [Time frame: Post-intervention (Week 8)]
Eligibility criteria
Inclusion criteria
- 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.
- Montreal Cognitive Assessment≥21
- Stable pharmacological treatment.
- Physician's approval for exercise participation.
Exclusion criteria
- 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.
- Engaged in regular moderate-intensity exercise more than once a week in the last 6 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07660978 · E-35700536-108.99-176309