COMPARATIVE EFFECTIVENESS of COLLABORATIVE VIRTUAL ENVIRONMENT and NON-IMMERSIVE VIRTUAL REALITY in the REHABILITATION of PATIENTS With PARKINSON'S DISEASE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- MDS-UPDRS-III
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor will be blinded for the purpose of avoiding biase
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
CVE
Participants in this arm will receive rehabilitation through a Collaborative Virtual Reality Environment (CVE), where both the patient and therapist interact simultaneously within a shared virtual space. The intervention is delivered using a head-mounted display-based system that enables real-time communication, guidance, and feedback.
The rehabilitation program consists of task-specific, goal-oriented exercises targeting upper limb function, gait, balance, and functional mobility. Activities are designed to simulate real-world movements and include object manipulation, reaching tasks, and controlled walking scenarios. The therapist actively supervises and adapts the exercises during each session, ensuring appropriate progression based on patient performance.
The collaborative nature of the environment facilitates increased engagement, motor learning, and adherence by incorporating interactive elements and immediate corrective feedback. The intervention follows structured progressio
干预措施: Collaborative Virtual Environment (Other)
NIVR
Participants in this arm will undergo rehabilitation using a Non-Immersive Virtual Reality (NIVR) system delivered through a standard screen-based interface. The intervention without the use of head-mounted displays or real-time collaborative features.
The rehabilitation program includes task-oriented exercises focusing on upper limb function, balance, gait-related activities, and overall functional mobility. These exercises are designed to replicate real-world movements and are performed in a structured and repetitive manner to promote motor learning.
Participants will perform the activities independently with periodic supervision from a therapist. Feedback is primarily system-generated, and progression is based on predefined levels of difficulty within the software. The intervention emphasizes consistency, task specificity, and gradual progression throughout the study
干预措施: Non-Immersive Virtual Reality (NIVR) (Other)
结局指标
主要结局
MDS-UPDRS-III
时间窗: From enrollment to the end of treatment at12 weeks
The MDS-UPDRS-III is a clinician-administered scale used to assess motor impairment in individuals with Parkinson's disease. It evaluates key domains including bradykinesia, rigidity, tremor, postural stability, and gait through a series of standardized physical examination items. Each item is scored on a 5-point ordinal scale ranging from 0 (normal) to 4 (severe impairment), with higher total scores indicating greater motor dysfunction. The scale provides a comprehensive measure of motor severity and is widely used in both clinical and research settings due to its strong reliability and validity. Changes in MDS-UPDRS-III scores over time will be used to determine the effectiveness of the intervention in improving motor function.
Timed Up and Go (TUG) Test
时间窗: Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks)
The Timed Up and Go (TUG) Test is a standardized clinical measure used to assess functional mobility, balance, and risk of falls in individuals with Parkinson's disease. The test requires the participant to stand up from a seated position, walk a distance of approximately 3 meters, turn around, walk back to the chair, and sit down. The total time taken to complete the task is recorded in seconds. Shorter completion times indicate better functional mobility and balance performance, whereas longer times may reflect impaired mobility and increased fall risk. The TUG test is widely recognized for its simplicity, reliability, and sensitivity to changes following rehabilitation interventions.
次要结局
- Falls Efficacy Scale-International (FES-I)(Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks))
- Parkinson's Disease Fatigue Scale (PFS-16)(Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks))
- Action Research Arm Test (ARAT)(Assessed at baseline (pre-intervention) and at the end of the intervention period (12 weeks))
研究者
Hafiz Muddassir Riaz
Principal Investigator (PI)
Superior University