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临床试验/NCT07251231
NCT07251231尚未招募不适用

Effectiveness of Virtual Reality in Parkinson's Disease: Impact on Balance, Fall Risk, and Cardiorespiratory Exercise Capacity.

University of Valencia2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年5月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
2
主要终点
Balance

研究概览

简要总结

The goal of this clinical trial is to evaluate whether immersive virtual reality (VR)-based physiotherapy is effective in improving balance, reducing fall risk, and enhancing cardiorespiratory exercise capacity in individuals with Parkinson's disease. The main questions it aims to answer are:

Does immersive VR therapy improve postural balance more effectively than conventional physiotherapy?

Does immersive VR reduce fall risk and increase cardiorespiratory fitness compared with standard physiotherapy?

Researchers will compare an immersive VR intervention with conventional physiotherapy to determine whether VR can produce superior functional and physiological outcomes in patients with Parkinson's disease.

Participants will:

Be randomly assigned (1:1) to an experimental group (immersive VR therapy) or a control group (conventional physiotherapy).

Take part in structured physiotherapy sessions focused on balance, mobility, and functional capacity.

Undergo pre- and post-intervention assessments of balance, fall risk, cardiorespiratory exercise capacity, and quality of life.

This randomized controlled trial (RCT) with parallel assignment will include 50 participants (25 per group). Randomization will be performed using the OxMaR (Oxford Minimization and Randomization) software, which enables adaptive randomization to ensure balanced baseline characteristics between groups.

Secondary objectives include evaluating the impact of immersive VR on health-related quality of life and comparing treatment adherence between VR-based and conventional physiotherapy interventions.

详细描述

Neurological disorders are among the leading causes of disability worldwide, significantly affecting functional independence, mobility, and quality of life. Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by dopaminergic neuron loss in the substantia nigra, resulting in motor and non-motor symptoms that compromise multiple physiological systems. The main motor symptoms-bradykinesia, rigidity, resting tremor, and postural instability-directly impair balance and substantially increase the risk of falls. Additionally, individuals with PD often exhibit reduced cardiorespiratory fitness, which contributes to functional decline, decreased participation in daily activities, and increased caregiver burden.

Physiotherapy plays a crucial role in the comprehensive management of PD, targeting improvements in balance, mobility, motor function, and cardiorespiratory capacity to delay disability and promote autonomy. In recent years, emerging technologies have transformed conventional rehabilitation paradigms, with virtual reality (VR) gaining recognition as a promising tool for enhancing therapeutic outcomes.

Immersive VR systems provide controlled, interactive, and multisensory environments that facilitate repetitive, task-oriented motor practice with immediate sensory feedback. These features can increase motivation, engagement, and adherence to therapy, while simultaneously stimulating both motor and cognitive domains. Moreover, VR interventions may induce neuromodulation processes by activating and reorganizing neural circuits, thereby promoting neuroplasticity - a fundamental mechanism for functional recovery in neurodegenerative diseases such as PD.

Preliminary research suggests that VR-based rehabilitation can lead to measurable improvements in balance, reduction in fall risk, and enhancement of physical endurance. However, the current body of evidence remains limited by small sample sizes, heterogeneous methodologies, and a lack of direct comparisons with conventional physiotherapy. Gaps persist regarding which subgroups of PD patients benefit most, the medium- and long-term effects of VR interventions, and the neurophysiological mechanisms underlying these improvements.

This randomized controlled trial (RCT) aims to address these limitations by conducting a rigorous evaluation of an immersive VR intervention compared to standard physiotherapy in individuals with PD. A total of 50 participants will be randomly assigned (1:1) to either a VR group or a conventional physiotherapy group using the OxMaR (Oxford Minimization and Randomization) software, which employs adaptive minimization to balance baseline characteristics between groups.

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)

入排标准

年龄范围
55 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 55 and 75 years.
  • •Clinical diagnosis of Parkinson's disease confirmed by a neurologist.
  • •Mild to moderate disease stage (Hoehn and Yahr I-III).
  • •Ability to understand and follow simple instructions and actively participate in the intervention.
  • •Signed informed consent provided before participation.

排除标准

  • •Severe cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score <
  • •Severe musculoskeletal comorbidities that limit mobility or prevent participation in physiotherapy sessions.
  • •Visual or vestibular disorders that would compromise safe use of virtual reality equipment.
  • •Serious medical complications during the study (e.g., acute cardiovascular events such as myocardial infarction or stroke) that may endanger the participant or interfere with treatment.
  • •Adverse effects related to the intervention, including severe dizziness, persistent nausea, disorientation, or headaches that prevent continuation of therapy.
  • •Lack of adherence to the protocol, defined as missing four or more intervention sessions without justification.
  • •Significant worsening of neurological status or new complications that contraindicate participation in physiotherapy.
  • •Surgical or medical procedures unrelated to Parkinson's disease that affect general mobility or the ability to participate in the intervention.

研究组 & 干预措施

Virtual Reality

Experimental

Participants receiving an intervention through Virtual Reality

干预措施: Virtual Reality (Other)

Conventional Rehabilitation

Active Comparator

Participants receiving conventional rehabilitation

干预措施: Conventional Rehabilitation (Other)

结局指标

主要结局

Balance

时间窗: From baseline to 12 weeks

Balance will be assessed using the Berg Balance Scale (BBS), a standardized and validated clinical tool widely used to evaluate static and dynamic balance in individuals with Parkinson's disease. The BBS consists of 14 functional tasks (such as standing up, reaching forward, turning, and standing on one foot), each scored on a 5-point scale ranging from 0 (unable to perform) to 4 (normal performance). The total score ranges from 0 to 56 points, with higher scores indicating better balance and lower fall risk. Assessments will be conducted by trained physiotherapists blinded to group allocation to ensure objectivity and minimize bias.

Balance

时间窗: From baseline to 12 weeks

Balance will be assessed using the Berg Balance Scale (BBS), a standardized and validated clinical tool widely used to evaluate static and dynamic balance in individuals with Parkinson's disease. The BBS consists of 14 functional tasks (such as standing up, reaching forward, turning, and standing on one foot), each scored on a 5-point scale ranging from 0 (unable to perform) to 4 (normal performance). The total score ranges from 0 to 56 points, with higher scores indicating better balance and lower fall risk. Assessments will be conducted by trained physiotherapists blinded to group allocation to ensure objectivity and minimize bias.

次要结局

  • Fall Risk and Functional Mobility(From baseline to 12 weeks)
  • Cardiorespiratory Exercise Capacity(From baseline to 12 weeks)
  • Fall Risk and Functional Mobility(From baseline to 12 weeks)
  • Cardiorespiratory Exercise Capacity(From baseline to 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Borja Pérez-Domínguez

Associate Professor

University of Valencia

研究点 (2)

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