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

NCT07251231 | Not Yet Recruiting

• 1 other identifier: 2025-FIS-3990912
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Virtual Reality; Postural Balance; Frailty; Exercise Tolerance

Outcome Measures

Primary Outcomes (1)

• Balance

  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.

  From baseline to 12 weeks

Secondary Outcomes (2)

• Fall Risk and Functional Mobility

  From baseline to 12 weeks

• Cardiorespiratory Exercise Capacity

  From baseline to 12 weeks

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Participants receiving an intervention through Virtual Reality

Other: Virtual Reality

Conventional Rehabilitation

ACTIVE COMPARATOR

Participants receiving conventional rehabilitation

Other: Conventional Rehabilitation

Interventions

Virtual Reality OTHER

Rehabilitation through a Virtual Reality program

Virtual Reality

Conventional Rehabilitation OTHER

Rehabilitation received through conventional programs

Conventional Rehabilitation

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Faculty of Physiotherapy. University of Valencia

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Parkinson Disease; Frailty

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 28, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)