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

Официальное название

Effects of Cognitive-Based Balance Rehabilitation on Balance, Gait and Cognitive Functions in Parkinson's Disease Patients: Comparison of Virtual Reality and Dual Task

Обзор

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.

Вмешательства

• Другое 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
• Другое 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

Первичные конечные точки

• Mini-Balance Evaluations Systems Test [Срок оценки: Baseline and Week 8]

Вторичные конечные точки (7)

• Montreal Cognitive Assessment [Срок оценки: Baseline and Week 8]
• Biodex Balance System [Срок оценки: Baseline and Week 8]
• Unified Parkinson's Disease Rating Scale - Part III (Motor Examination) [Срок оценки: Baseline and Week 8]
• Parkinson's Disease Questionnaire-39 [Срок оценки: Baseline and Week 8]
• Freezing of Gait Questionnaire [Срок оценки: Baseline and Week 8]
• Global Rating of Change Scale [Срок оценки: Post-intervention (Week 8)]
• Virtual Reality Sickness Questionnaire [Срок оценки: Post-intervention (Week 8)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07660978 · E-35700536-108.99-176309

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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