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Идёт набор NCT07523425

Collaborative vs Non-Immersive VR in Parkinson's Rehabilitation

Без фазы С лечением Parkinson Desease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Collaborative Virtual Environment, Non-Immersive Virtual Reality (NIVR).
Кому может быть актуально
Состояния в реестре: Parkinson Desease. Базовые параметры: 45 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пакистан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

COMPARATIVE EFFECTIVENESS of COLLABORATIVE VIRTUAL ENVIRONMENT and NON-IMMERSIVE VIRTUAL REALITY in the REHABILITATION of PATIENTS With PARKINSON'S DISEASE

Обзор

This randomized controlled trial aims to compare the effectiveness of a Collaborative Virtual Reality Environment (CVE) and Non-Immersive Virtual Reality (NIVR) in the rehabilitation of patients with Parkinson's disease. Participants with mild to moderate disease severity will be randomly assigned to either the CVE group or the NIVR group. The CVE intervention will involve therapist-guided, interactive virtual exercises in a shared environment, promoting real-time engagement and feedback. The NIVR group will perform task-oriented exercises using screen-based virtual reality without immersive and collaborative features. Both interventions will be delivered over an 12-week period. Primary outcomes will assess motor function using standardized clinical scales, while secondary outcomes will evaluate cognitive function, mobility, and quality of life. The study seeks to determine whether collaborative and interactive virtual rehabilitation provides superior clinical outcomes compared to conventional non-immersive virtual approaches in patients with Parkinson's disease.

Подробное описание

This study is designed to investigate the comparative therapeutic value of two distinct virtual reality-based rehabilitation teatement in individuals diagnosed with Parkinson's disease. The focus is on understanding how differences in interaction design, immersion level, and therapist involvement influence clinical outcomes.

The intervention framework is structured around task-oriented, goal-directed activities targeting both motor and cognitive domains commonly affected in Parkinson's disease. The Collaborative Virtual Reality Environment (CVE) incorporates a shared virtual space where the patient and therapist interact synchronously. This setup enables real-time guidance, adaptive feedback, and enhanced engagement through social and therapeutic presence. In contrast, the Non-Immersive Virtual Reality (NIVR) condition delivers similar rehabilitation tasks via a conventional screen-based interface without immersive or collaborative elements, relying primarily on self-directed patient interaction.

The rehabilitation protocol emphasizes functional movement patterns, including upper limb coordination, gait-related tasks, and balance. The virtual exercises are designed to align with established neurorehabilitation principles such as repetition, task specificity, and feedback-driven motor learning. Progression within the intervention is structured through graded task difficulty and performance-based adjustments.

Outcome evaluation focuses on quantifying changes in motor performance, cognitive function, functional mobility, and health-related quality of life using validated clinical instruments. Data will also be used to explore the relationship between user engagement characteristics and rehabilitation outcomes.

The study aims to generate evidence on whether integrating collaboration and immersion into virtual rehabilitation environments offers clinically meaningful advantages over conventional non-immersive approaches, thereby informing future design and implementation of technology-assisted neurorehabilitation systems.

Вмешательства

  • Другое Collaborative Virtual Environment
    Collaborative Virtual Reality Environment (CVE), participants perform exercises within a shared virtual space alongside a therapist, enabling real-time interaction, guidance, and adaptive feedback.
  • Другое Non-Immersive Virtual Reality (NIVR)
    Physiotherapy-based rehabilitation delivered through a screen-based virtual environment, involving structured, task-oriented exercises performed with limited therapist interaction

Первичные конечные точки

  • MDS-UPDRS-III [Срок оценки: From enrollment to the end of treatment at12 weeks]
  • Timed Up and Go (TUG) Test [Срок оценки: Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)]
Вторичные конечные точки (3)
  • Falls Efficacy Scale-International (FES-I) [Срок оценки: Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)]
  • Parkinson's Disease Fatigue Scale (PFS-16) [Срок оценки: Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)]
  • Action Research Arm Test (ARAT) [Срок оценки: Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)]

Критерии участия

Критерии включения

  • Male and Female
  • Age: 45 years-80 Years
  • Diagnosed patients of idiopathic Parkinson Disease with minor to moderate severity according to the Hoehn \& Yahr stages I-III.
  • On conventional and stable medical treatment at present
  • No severe cognitive impairments (MMSE ≥ 24).
  • Ability to participate in virtual rehabilitation sessions
  • Willingness to participate and provide informed consent

Критерии исключения

  • Severe visual, auditory, or motor impairments unrelated to Parkinson's.
  • Fear of virtual environment.
  • Comorbidities that hinder participation in the treatment (e.g., advanced dementia).
  • Severe musculoskeletal conditions limiting movement
  • History of epilepsy or conditions contraindicating virtual reality exposure
  • Participation in another interventional study within the last 3 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
Организация здравоохранения

Центры проведения

Пакистан · 1 центр
  • Punjab Institute of Neurosciences Lahore — Lahore

Идентификаторы

NCT: NCT07523425 · PhD/RS-4623-A

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗