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

Not Yet RecruitingNA

Sponsor: University of Valencia

Conditions: Parkinson Disease

Interventions: Virtual Reality, Conventional Rehabilitation

Countries: Spain

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.

Eligibility overview

Sex: ALL

Age: 55 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Severe cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score \< 21.
* 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.

Locations (1)

Valencia, Valencia, Spain