Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

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

23 июня 2026 г. обновлено: Bezmialem Vakif University

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

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.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

34

Фаза

  • Непригодный

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: Dual Task Group
Participants in this group will undergo a supervised, structured therapeutic exercise program specifically designed for balance and postural control, which will be integrated with concurrent, increasingly complex cognitive tasks (such as counting backward, calculation, or memory retrieval). The intervention will consist of 45-minute sessions held twice a week for 8 consecutive weeks, totaling 16 sessions. All exercises will be conducted by a physiotherapist during the patients' pharmacological 'on' phase.
Другой: 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 certified physiotherapist.
Активный компаратор: Virtual Reality Group
Participants in this group will engage in an immersive Virtual Reality (VR) balance rehabilitation program utilizing the Oculus Quest 3® headset. They will play the clinically validated FIT-XR application, which is tailored to target upper and lower extremity coordinate functions and dynamic balance. The exercise intensity, session duration (45 minutes), and frequency (twice a week for 8 weeks, totaling 16 sessions) will be identical to the Dual Task Group. Sessions will be supervised by a physiotherapist during the patients' pharmacological 'on' phase, with full safety protocols implemented to prevent fall risks.
Другой: 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 are fully supervised by a physiotherapist with standard safety measures.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Mini-Balance Evaluations Systems Test
Временное ограничение: Baseline and Week 8
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.
Baseline and Week 8

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Montreal Cognitive Assessment
Временное ограничение: Baseline and Week 8
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.
Baseline and Week 8
Biodex Balance System
Временное ограничение: Baseline and Week 8
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.
Baseline and Week 8
Unified Parkinson's Disease Rating Scale - Part III (Motor Examination)
Временное ограничение: Baseline and Week 8
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.
Baseline and Week 8
Parkinson's Disease Questionnaire-39
Временное ограничение: Baseline and Week 8
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.
Baseline and Week 8
Freezing of Gait Questionnaire
Временное ограничение: Baseline and Week 8
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.
Baseline and Week 8
Global Rating of Change Scale
Временное ограничение: Post-intervention (Week 8)
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.
Post-intervention (Week 8)
Virtual Reality Sickness Questionnaire
Временное ограничение: Post-intervention (Week 8)
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.
Post-intervention (Week 8)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Bezmialem Vakif University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

20 июня 2026 г.

Первичное завершение (Оцененный)

30 июня 2027 г.

Завершение исследования (Оцененный)

30 декабря 2027 г.

Даты регистрации исследования

Первый отправленный

16 июня 2026 г.

Впервые представлено, что соответствует критериям контроля качества

16 июня 2026 г.

Первый опубликованный (Действительный)

22 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

25 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

23 июня 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • E-35700536-108.99-176309

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Подписаться