Design And Analysis of The Effectiveness of Collaborative Virtual Reality Environment Versus Non-Immersive Virtual Reality in the Rehabilitation of Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Unified Parkinson's disease Rating Scale Part III
研究概览
简要总结
This study is being conducted to investigate the effect of Collaborative Virtual Reality Environments versus non-immersive Virtual reality-based rehabilitation in addition to the conventional Physical Therapy for patients with Parkinson's Disease to improve the motor, cognitive function, and overall quality of life.
详细描述
Parkinson's Disease is a progressive, neurodegenerative disorder with sign and symptoms of resting tremor, rigidity, retropulsion, stooping posture, sluggishness of spontaneous actions, with masked face. Parkinson's disease is increasing worldwide every year. Besides medical or surgical treatment, task-oriented Physical Therapy exercises have shown improvement in balance, reducing falls, and enhancing motor functions. Virtual reality (VR) has also appeared to be a promising means for rehabilitation in this disease. Collaborative Virtual Environments are shared digital spaces that enable real-time collaboration and interaction, often represented through avatars. Rehabilitation treatment with such advanced virtual reality technology i.e., comparing Collaborative Virtual Environments (CVEs) and Non-Immersive Virtual Reality to enhance motor functions along with cognitive tasks in Parkinson's disease may transform Physiotherapy rehabilitation by advocating engaging, effective, and scalable interventions, ultimately improving the outcomes and quality of life in Parkinson's disease.
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
- None
入排标准
- 年龄范围
- 40 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender: Both Male and Female genders patients
- •Age Range: 40 years -80 Years
- •Diagnosis: Clinically diagnosed patients of idiopathic Parkinson Disease classified as mild to moderate severity according to the modified Hoehn & Yahr stages I-III.
- •Cognitive Function: Adequate cognitive function as assessed by Mini Mental State Examination (score ≥ 24)
- •Functional Ability: can walk independently, must have sufficient physical and cognitive ability to engage in virtual rehabilitation sessions.
排除标准
- •History of any neurological conditions other than Parkinson's disease.
- •History of visual auditory, or motor impairments unrelated to Parkinson's Disease.
- •History of orthopedic injury leading to complications like any deformity.
- •Diagnosed phobia of virtual environment.
- •Comorbidities that hinder participation in the treatment (e.g., advanced dementia).
- •Patient taking another medication affecting neurological condition.
研究组 & 干预措施
Collaborative Virtual Reality with Routine Physical Therapy
干预措施: Collaborative Virtual Reality with Routine Physical Therapy (Combination Product)
Non-Immersive Virtual Reality with Routine Physical Therapy
干预措施: Non-Immersive Virtual Reality with Routine Physical Therapy (Combination Product)
结局指标
主要结局
Unified Parkinson's disease Rating Scale Part III
时间窗: 24 Months
The UPDRS Part III is a tool frequently employed in clinical settings to assess the motor functions of individuals with Parkinson's Disease. It encompasses a series of 31 items, which specifically evaluate motor symptoms such as tremor, rigidity, bradykinesia (slowness of movement), postural instability, and other related motor impairments. • Scoring: Total score range: 0 to 199. Higher scores indicate more severe motor dysfunction and greater disability.
Timed Up and Go Test
时间窗: 24 Months
The TUG test is a simple and effective measure of physical mobility, balance, and the risk of falls in individuals, especially those with Parkinson's Disease. It involves timing how long it takes a person to rise from a chair, walk 3 meters, turn around, walk back, and sit down again. The total time taken to complete the test is recorded in seconds. • Longer times suggest greater difficulty with mobility, balance, and overall motor function, which may indicate a higher fall risk and greater disability.
Parkinson's Disease Fatigue Scale (PFS-16)
时间窗: 24 Months
The PFS-16 is a self-reported tool that helps to assess the level of fatigue experienced by individuals with Parkinson's Disease. It consists of 16 questions that cover the frequency and impact of fatigue on daily life. • Scoring: Each item is rated on a scale from 1 to 5, where 1 = never and 5 = always. Total score range: 16 to 80
次要结局
未报告次要终点
研究者
Muhammad Naveed Babur
Principal Investigator
Superior University