Parkinson DiseaseParkinsonNCT07251231
Effectiveness of Virtual Reality in Parkinson's Disease: Effects on Balance, Fall Risk, and Exercise Capacity.
A study testing Virtual Reality and Conventional Rehabilitation in people with Parkinson Disease, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Virtual Reality and Conventional Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 30 May 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Faculty of Physiotherapy. University of Valencia
Valencia, Valencia, 46010
Borja Perez-Dominguez, PhD, +34 697464680, f.borja.perez@uv.es
Jose Casaña, PhD, +34 656437371, jose.casana@uv.es
About this study
Official title: Effectiveness of Virtual Reality in Parkinson's Disease: Impact on Balance, Fall Risk, and Cardiorespiratory Exercise Capacity.
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?
Read more
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.
Read the detailed description
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.
The primary objective is to determine whether immersive VR therapy leads to greater improvements in postural balance, fall risk reduction, and cardiorespiratory exercise capacity compared to conventional physiotherapy. Secondary objectives include assessing changes in health-related quality of life and evaluating adherence to treatment protocols across intervention groups.
By integrating neurorehabilitation principles with immersive technology, this study aims to contribute robust scientific evidence supporting the use of VR as an effective physiotherapeutic tool for enhancing functional outcomes and overall well-being in individuals with Parkinson's disease.
- Conditions
- Parkinson Disease
- Being tested
- Virtual Reality, Conventional Rehabilitation
- Keywords
- Parkinson Disease, Virtual Reality, Postural Balance, Frailty, Exercise Tolerance
- Medical subject headings
- Parkinson Disease, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
Rehabilitation through a Virtual Reality program
Conventional RehabilitationOther
Rehabilitation received through conventional programs
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Participants receiving an intervention through Virtual Reality Receives: Other: Virtual Reality |
| Conventional Rehabilitation | Active comparator | Participants receiving conventional rehabilitation Receives: Other: Conventional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 12 weeks
Secondary outcomes (2)
Fall Risk and Functional Mobility
Fall risk and functional mobility will be evaluated using two standardized clinical tests: the Timed Up and Go Test (TUG) and the Dynamic Gait Index (DGI).
The TUG test measures the time (in seconds) it takes for a participant to stand up from a chair, walk three meters, turn, return, and sit down. Shorter times indicate better mobility and lower fall risk.
The DGI assesses dynamic balance during walking tasks such as changing speed, turning the head, and stepping over obstacles. It includes 8 items scored from 0 to 3, with a maximum score of 24 points. Higher scores represent better gait stability and lower risk of falls.
Measured: From baseline to 12 weeks
Cardiorespiratory Exercise Capacity
Cardiorespiratory exercise capacity will be assessed using the 6-Minute Walk Test (6MWT), a validated and widely used measure of submaximal aerobic capacity in individuals with Parkinson's disease. During the test, participants are instructed to walk as far as possible along a 30-meter corridor for six minutes at a self-paced but consistent effort level.
The total distance walked (in meters) will be recorded as the outcome variable. Greater distances indicate improved exercise tolerance and cardiorespiratory fitness.
All tests will be conducted under standardized conditions, with continuous supervision by trained physiotherapists to ensure safety. Participants may rest as needed, but the timer will continue running.
Measured: From baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start30 May 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Borja Pérez-Domínguez, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251231
- Sponsor's protocol ID
- 2025-FIS-3990912
- Acronym
- Parkinson
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality in Parkinson's Disease: Impact on Balance, Fall Risk, and Cardiorespiratory Exercise Capacity.
- ClinicalTrials.gov ID
- NCT07251231
- Acronym / sponsor ID
- Parkinson / 2025-FIS-3990912
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Virtual Reality, Postural Balance, Frailty, Exercise Tolerance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The primary objective is to determine whether immersive VR therapy leads to greater improvements in postural balance, fall risk reduction, and cardiorespiratory exercise capacity compared to conventional physiotherapy. Secondary objectives include assessing changes in health-related quality of life and evaluating adherence to treatment protocols across intervention groups.
By integrating neurorehabilitation principles with immersive technology, this study aims to contribute robust scientific evidence supporting the use of VR as an effective physiotherapeutic tool for enhancing functional outcomes and overall well-being in individuals with Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Other: Virtual RealityParticipants receiving an intervention through Virtual Reality |
| Conventional Rehabilitation | Active comparator | Other: Conventional RehabilitationParticipants receiving conventional rehabilitation |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityRehabilitation through a Virtual Reality program | Other | Virtual Reality |
| Conventional RehabilitationRehabilitation received through conventional programs | Other | Conventional Rehabilitation |
Primary outcome
Balance
Time frame: 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.
2 secondary outcomes
Fall Risk and Functional Mobility
Time frame: From baseline to 12 weeks
Cardiorespiratory Exercise Capacity
Time frame: From baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Conventional Rehabilitation in people with Parkinson Disease, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: From baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.