Differential Motor and Cognitive Responses to Two Virtual Reality-Based Rehabilitation Approaches in Parkinson's Disease: A Pilot Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Gait Speed
研究概览
简要总结
Parkinson's disease commonly affects walking ability, balance, mobility, and cognitive function, increasing the risk of falls and reducing independence. Virtual reality (VR) has emerged as a promising rehabilitation tool, but the potential differences between immersive and non-immersive VR approaches remain unclear.
This pilot randomized comparative study aims to evaluate the feasibility, safety, and preliminary effects of immersive virtual reality (IVR) and non-immersive virtual reality (NIVR) rehabilitation in individuals with Parkinson's disease. Participants will be assigned to either an immersive VR intervention using a head-mounted display or a non-immersive VR intervention using a tablet-based exergaming platform.
Both interventions will be delivered over six weeks and will target gait, balance, mobility, motor-cognitive interaction, and functional performance. Outcomes will include gait parameters, functional mobility, freezing of gait, cognitive function, adherence, and safety.
The findings will help determine whether different VR modalities produce distinct motor and cognitive responses and will inform the design of future larger clinical trials.
详细描述
Parkinson's disease is a progressive neurodegenerative disorder characterized by motor impairments such as gait dysfunction, postural instability, mobility limitations, and freezing of gait, as well as cognitive deficits affecting attention, executive function, and dual-task performance. These impairments contribute substantially to disability, fall risk, and reduced quality of life.
Virtual reality-based rehabilitation has emerged as a promising approach for delivering task-oriented, repetitive, and engaging interventions that simultaneously address motor and cognitive domains. However, immersive and non-immersive virtual reality systems differ substantially in their interaction characteristics, sensory feedback, and degree of user immersion, and their comparative effects in Parkinson's disease remain insufficiently understood.
The purpose of this pilot randomized comparative study is to evaluate the feasibility, safety, and preliminary clinical effects of immersive virtual reality (IVR) compared with non-immersive virtual reality (NIVR) rehabilitation in individuals with idiopathic Parkinson's disease.
Participants diagnosed with Parkinson's disease will be allocated to one of two intervention groups. The IVR group will receive rehabilitation using the KINESIX XR platform delivered through a head-mounted display with real-time motion tracking and three-dimensional interactive environments. The NIVR group will receive rehabilitation using the Active Arcade exergaming platform delivered on a tablet device. Both interventions will be supervised and delivered over a six-week period, consisting of ten treatment sessions in addition to baseline and post-intervention assessments.
Outcome measures will include spatiotemporal gait parameters, functional mobility, dual-task performance, turning ability, freezing of gait symptoms, cognitive function, adherence to treatment, and safety outcomes. Assessments will be conducted at baseline and immediately following completion of the intervention program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessments were performed by an evaluator who was blinded to group allocation. Participants and treating therapists were aware of the intervention received due to the nature of the virtual reality interventions, but the assessor responsible for baseline and post-intervention evaluations was not informed of treatment assignment.
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 45 and 75 years.
- •Diagnosis of idiopathic Parkinson's disease.
- •Hoehn and Yahr stage between 1.5 and
- •Ability to walk independently or with an assistive device (cane or walker).
- •Low to moderate fall risk, defined as a Timed Up and Go (TUG) score <20 seconds.
- •Ability to provide written informed consent.
排除标准
- •Diagnosis of other neurological or movement disorders.
- •Severe cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score <
- •Severe visual impairment not correctable with lenses.
- •History of epilepsy.
- •Uncontrolled psychiatric disorders.
- •Previous deep brain stimulation.
研究组 & 干预措施
Non-Immersive Virtual Reality Rehabilitation
Participants received non-immersive virtual reality-based rehabilitation using the Active Arcade exergaming platform delivered on a tablet device. The intervention consisted of supervised sessions targeting gait, balance, mobility, motor function, and cognitive performance. Participants completed ten intervention sessions over a six-week period.
干预措施: Non-Immersive Virtual Reality (Device)
Immersive Virtual Reality Rehabilitation
Participants received immersive virtual reality-based rehabilitation using the KINESIX XR platform delivered through a head-mounted display. The intervention consisted of supervised sessions targeting gait, balance, mobility, motor function, and cognitive performance. Participants completed ten intervention sessions over a six-week period.
干预措施: Immersive Virtual Reality (Device)
结局指标
主要结局
Gait Speed
时间窗: Baseline and post-intervention (6 weeks)
Change in gait speed measured using the Baiobit wearable inertial sensor system (Rivelo, Italy) during walking assessments.
次要结局
- Time Up and Go Test(Baseline and post-intervention (6 weeks))
- Freezing of Test Questionnaire(Baseline and post-intervention (6 weeks))
- Dual-Task Time Up and Go(Baseline and post-intervention (6 weeks))
- Adherence Rate(Throughout the 6-week intervention period)
- Adverse Events(Throughout the 6-week intervention period)
- Step Leght(Baseline and post-intervention (6 weeks))
- Cadence(Baseline and post-intervention (6 weeks))
- Rapid Turn Test(Baseline and post-intervention (6 weeks))
- Montreal Cognitive Assessment(Baseline and post-intervention (6 weeks))