Parkinson Disease (PD)RVI-PDNCT07274514
Virtual Reality on Balance of Parkinson's Disease
A study testing Immersive Virtual Reality Program and Standard Rehabilitation Program in people with Parkinson Disease (PD) and Immersive Virtual Reality, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
Trial summary
This study, titled: Effectiveness of immersive virtual reality on balance in people with Parkinson's disease. Is a randomized clinical trial conducted at Zaragoza Parkinson's Association in Spain. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Parkinson Disease (PD), Immersive Virtual Reality, Physical Therapy
- What is being tested?
- Immersive Virtual Reality Program and Standard Rehabilitation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSpain
- Study dates
- 5 Feb 2025to 12 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PD confirmed by a neurologist
- Age between 55 and 90 years
- Hoehn \& Yahr Scale score of 1 to 4
- Cognitive level of 24 or higher on the Mini Mental Examination Test
- Ability to stand upright without assistance
Who cannot join
- Visual or auditory impairments that could interfere with the perception of information or trigger dizziness or epilepsy
- Musculoskeletal conditions that hinder or prevent the execution of exercises or the ability to maintain a standing position for at least 20 minutes
- Psychiatric disorders such as moderate or severe depression diagnosed in the last year and impulse control disorders diagnosed in the last year
- Score of 20 points on the Simulator Sickness Questionnaire (SSQ scale), indicating the presence of severe adverse symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Immersive Virtual Reality on Balance of Parkinson's Disease
This study, titled: Effectiveness of immersive virtual reality on balance in people with Parkinson's disease. Is a randomized clinical trial conducted at Zaragoza Parkinson's Association in Spain. It aims to evaluate the effectiveness of a immersive virtual reality program in enhancing balance for patients with Parkinson.s disease (PD). PD is a neurodegenerative disease that has a major impact on patients' balance and gait, affecting their quality of life. Physical rehabilitation is crucial for maintaining and improving balance, and immersive virtual reality promises to be an alternative for improving outcomes in patients with PD.
Read the detailed description
Study Backgroud and Rationale: Parkinson's disease (PD) is one of the most common neurogenerative disease. Parkinson's disease is one of the most common neurodegenerative diseases. Patients suffering from it present a series of motor symptoms, including resting tremors, hyperresistance, bradykinesia, postural instability, and gait disturbances. Postural instability leads to an increase in the number of falls, which leads to greater dependence and social isolation, resulting in a reduced quality of life. Usual physical therapy techniques show an improvement in the motor skills of people with PD; however, their effectiveness is sometimes limited by patient adherence. Objective: The primary objective of this study is to determine whether the Immersive Virtual Reality (IVR) program rehabilitation can improve the balance of people with PD by Mini-Balance Systems Test (Mini-BESTest). Secondary objectives included assessing changes in gait speed, lower limbs strength, functional mobility, quality of life, adherence to the treatment and the possible occurrence of adverse symptoms during the use of IVR. Study Design: This is a single-blind, randomized clinical trial. Fifty patients with PD will be recruited and randomly assigned to either the control group, wich will receive balance conventional physiotherapy rehabilitation thought or the intervention group, wich will receive a IVR program rehabilitation. Both groups will undergo a comprehensive rehabilitation program that will include: active mobility exercises, strength exercises for the main antigravity muscles, and active stretching of the main muscles of the posterior chain. Methodology: There will be eight 40-minute sessions over four weeks. The first 20 minutes will be the same for both groups, while the second part of the session will vary between the control group (standard physical therapy) and the intervention group (IVR).
- Being tested
- Immersive Virtual Reality Program, Standard Rehabilitation Program
- Keywords
- Immersive Virtual Reality, Balance, Physical Therapy, Quality of life, Gait, Strength, parkinson's disease, virtual reality
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality ProgramOther
The participants in the intervention group will receive a Immersive Virtual Reality Rehabilitation Program to improve static and dynamic balance and quality of life
Standard Rehabilitation ProgramOther
The participants in the control group will receive a Standard Physical Therapy Rehabilitation Program to improve static and dynamic balance and quality of life
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group. Immersive Virtual Reality Rehabilitation Program | Experimental | The participants in the experimental group will receive a immersive virtual reality rehabilitation program to improve static and dynamic balance and quality of life. Receives: Other: Immersive Virtual Reality Program |
| Control Group. Standard Rehabilitation Program | Active comparator | The participants in the control group will receive a standard physical therapy rehabilitation program to improve static and dynamic balance and quality of life Receives: Other: Standard Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance-Mini-Balance Systems Test (Mini-BESTest)
The primary outcome is the improvement in balnace, which will be evaluated using the Mini-Balance Systems Test (Mini-BESTest). This test assesses static and dynamic balance disorders and determines the risk of falling by evaluating 14 items divided into 4 categories: anticipatory, reactive postural control, sensory orientation and dynamic gait. recovery.static and dynamic balance disorders and determines the risk of falling
Measured: Balance will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).
Secondary outcomes (8)
Gait speed-10-Meter Walk Test (10MWT)
Evaluate improvements in gait speed using the 10 meters walk test (10=MWT). The aim is to determine whether the immersive virtual reality program can enhance gait speed as compared to the usual physiotherapy approach.
Measured: Gait speed will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).
Lower Limb Muscle Strength - 30 seconds Sit to Stand Test (30 CST)
Evaluate lower limb muscle strength using the 30 seconds sit-to-stand test (30CST). This assessment will provide data on the effectiveness of the immersive virtual reality program in improving lower extremity muscle strength
Measured: Lower Limb Muscle Strength will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).
Functional mobility during walking-Time up and Go (TUG)
Assess the functional mobility during walking, as well as the risk of falling
Measured: Balance will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).
Functional mobility performing a dual task-Time Up & Go Dual Task (TUG-DT):
Asses functional mobility during walking, as well as the risk of falling while performing a dual task with Time Up and Go Dual Task (TUG-DT)
Measured: Functional mobility performing a dual task will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).
Quality of life- Parkinson Disease Questionnaire-39 (PDQ-39
Assess health-related quality of life in people with PD. This self-administered questionnaire consists of 39 items, divided into eight dimensions (mobility, activities of daily living,emotional well-being,stigma, social support, cognition, comunication, bodily discomfort.
Measured: Quality of life will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).
Adverse symptoms- Simulator Sickness Questionnaire (SSQ)
Assess the occurrence of adverse symptoms during the Immersive Virtual Reality Program using the Simulator Sickness Questionnaire (SSQ). This questionnaire consists of 16 items divided into three sections: Oculomotor Function, Nausea, and Disorientation.
Measured: Through intervention completion, an average of 1 month.
Adherence to the Immersive Virtual reality program
Evaluate compliance with the immersive virtual reality program by monitoring the percentage of sessions completed by participants. The compliance rate will be calculated as the number of sessions completed relative to the total number of program sessions.
Measured: Through intervention completion, an average of 1 month.
Satisfaction with Immersive Virtual Reality Program
Evaluate participant satisfaction with the immersive virtual reality program using a standardized ad hoc questionnaire on a 5- point Likert scale, scored of 1 to 5, with higher scores indicating greater satisfaction.
Measured: Satisfaction with Immersive Virtual Realiity program will be assessed at two time points: the day post-intervention (M1), and 90 days post-intervention (M2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start5 Feb 2025
- Primary completion27 Feb 2026
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- 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
- Single-blind randomized clinical trial with two parallel interventions
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria Aragón
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad San Jorge, Universidad de Zaragoza
- Responsible party
- Principal investigator, Sandra Calvo Carrión, Instituto de Investigación Sanitaria Aragón
- Investigators
- Sandra Calvo, PhD, Principal investigator, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274514
- Sponsor's protocol ID
- UZ-USJ-PD
- Acronym
- RVI-PD
- Status last verified
- Oct 2025
- First submitted
- 21 Aug 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Morcillo-Martinez L, Sanz-Marmol M, Romanos-Navarrete AI, Calvo S, Le Roux-Etheve L, Esteban-Repiso L, Cordova-Alegre P, Jimenez-Sanchez C, Garay-Sanchez A, la Cruz NB. Effects of a level-based immersive virtual reality physical therapy program on static and dynamic balance in Parkinson's disease: Protocol for a randomized controlled trial. PLoS One. 2026 Mar 16;21(3):e0344457. doi: 10.1371/journal.pone.0344457. eCollection 2026.
PubMed 41838745
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Immersive Virtual Reality on Balance of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07274514
- Acronym / sponsor ID
- RVI-PD / UZ-USJ-PD
- Keywords
- Immersive Virtual Reality, Balance, Physical Therapy, Quality of life, Gait, Strength, parkinson's disease, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria AragónUniversity, hospital or other
- Collaborators
- Universidad San Jorge, Universidad de Zaragoza
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 10 Dec 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.
This study, titled: Effectiveness of immersive virtual reality on balance in people with Parkinson's disease. Is a randomized clinical trial conducted at Zaragoza Parkinson's Association in Spain. It aims to evaluate the effectiveness of a immersive virtual reality program in enhancing balance for patients with Parkinson.s disease (PD). PD is a neurodegenerative disease that has a major impact on patients' balance and gait, affecting their quality of life. Physical rehabilitation is crucial for maintaining and improving balance, and immersive virtual reality promises to be an alternative for improving outcomes in patients with PD.
Detailed description
Study Backgroud and Rationale: Parkinson's disease (PD) is one of the most common neurogenerative disease. Parkinson's disease is one of the most common neurodegenerative diseases. Patients suffering from it present a series of motor symptoms, including resting tremors, hyperresistance, bradykinesia, postural instability, and gait disturbances. Postural instability leads to an increase in the number of falls, which leads to greater dependence and social isolation, resulting in a reduced quality of life. Usual physical therapy techniques show an improvement in the motor skills of people with PD; however, their effectiveness is sometimes limited by patient adherence. Objective: The primary objective of this study is to determine whether the Immersive Virtual Reality (IVR) program rehabilitation can improve the balance of people with PD by Mini-Balance Systems Test (Mini-BESTest). Secondary objectives included assessing changes in gait speed, lower limbs strength, functional mobility, quality of life, adherence to the treatment and the possible occurrence of adverse symptoms during the use of IVR. Study Design: This is a single-blind, randomized clinical trial. Fifty patients with PD will be recruited and randomly assigned to either the control group, wich will receive balance conventional physiotherapy rehabilitation thought or the intervention group, wich will receive a IVR program rehabilitation. Both groups will undergo a comprehensive rehabilitation program that will include: active mobility exercises, strength exercises for the main antigravity muscles, and active stretching of the main muscles of the posterior chain. Methodology: There will be eight 40-minute sessions over four weeks. The first 20 minutes will be the same for both groups, while the second part of the session will vary between the control group (standard physical therapy) and the intervention group (IVR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind randomized clinical trial with two parallel interventions
| Arm | Type | Receives |
|---|---|---|
| Intervention Group. Immersive Virtual Reality Rehabilitation Program | Experimental | Other: Immersive Virtual Reality ProgramThe participants in the experimental group will receive a immersive virtual reality rehabilitation program to improve static and dynamic balance and quality of life. |
| Control Group. Standard Rehabilitation Program | Active comparator | Other: Standard Rehabilitation ProgramThe participants in the control group will receive a standard physical therapy rehabilitation program to improve static and dynamic balance and quality of life |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of PD confirmed by a neurologist
- Age between 55 and 90 years
- Hoehn \& Yahr Scale score of 1 to 4
- Cognitive level of 24 or higher on the Mini Mental Examination Test
- Ability to stand upright without assistance
Key exclusion criteria (4 listed)
- Visual or auditory impairments that could interfere with the perception of information or trigger dizziness or epilepsy
- Musculoskeletal conditions that hinder or prevent the execution of exercises or the ability to maintain a standing position for at least 20 minutes
- Psychiatric disorders such as moderate or severe depression diagnosed in the last year and impulse control disorders diagnosed in the last year
- Score of 20 points on the Simulator Sickness Questionnaire (SSQ scale), indicating the presence of severe adverse symptoms
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 |
|---|---|---|
| Immersive Virtual Reality ProgramThe participants in the intervention group will receive a Immersive Virtual Reality Rehabilitation Program to improve static and dynamic balance and quality of life | Other | Intervention Group. Immersive Virtual Reality Rehabilitation Program |
| Standard Rehabilitation ProgramThe participants in the control group will receive a Standard Physical Therapy Rehabilitation Program to improve static and dynamic balance and quality of life | Other | Control Group. Standard Rehabilitation Program |
Primary outcome
Balance-Mini-Balance Systems Test (Mini-BESTest)
Time frame: Balance will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).
The primary outcome is the improvement in balnace, which will be evaluated using the Mini-Balance Systems Test (Mini-BESTest). This test assesses static and dynamic balance disorders and determines the risk of falling by evaluating 14 items divided into 4 categories: anticipatory, reactive postural control, sensory orientation and dynamic gait. recovery.static and dynamic balance disorders and determines the risk of falling
8 secondary outcomes
Gait speed-10-Meter Walk Test (10MWT)
Time frame: Gait speed will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).
Lower Limb Muscle Strength - 30 seconds Sit to Stand Test (30 CST)
Time frame: Lower Limb Muscle Strength will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).
Functional mobility during walking-Time up and Go (TUG)
Time frame: Balance will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).
Functional mobility performing a dual task-Time Up & Go Dual Task (TUG-DT):
Time frame: Functional mobility performing a dual task will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).
Quality of life- Parkinson Disease Questionnaire-39 (PDQ-39
Time frame: Quality of life will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).
Adverse symptoms- Simulator Sickness Questionnaire (SSQ)
Time frame: Through intervention completion, an average of 1 month.
Adherence to the Immersive Virtual reality program
Time frame: Through intervention completion, an average of 1 month.
Satisfaction with Immersive Virtual Reality Program
Time frame: Satisfaction with Immersive Virtual Realiity program will be assessed at two time points: the day post-intervention (M1), and 90 days post-intervention (M2).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Derived from this study: PubMed 41838745Morcillo-Martinez L, Sanz-Marmol M, Romanos-Navarrete AI, Calvo S, Le Roux-Etheve L, Esteban-Repiso L, Cordova-Alegre P, Jimenez-Sanchez C, Garay-Sanchez A, la Cruz NB. Effects of a level-based immersive virtual reality physical therapy program on static and dynamic balance in Parkinson's disease: Protocol for a randomized controlled trial. PLoS One. 2026 Mar 16;21(3):e0344457. doi: 10.1371/journal.pone.0344457. eCollection 2026.
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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. This study is not recruiting at the moment.
Sandra Calvo, PhD principal investigator
Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality Program and Standard Rehabilitation Program in people with Parkinson Disease (PD) and Immersive Virtual Reality, run by Instituto de Investigación Sanitaria Aragón 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 4 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: finished, as of the sponsor's last update on 13 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance-Mini-Balance Systems Test (Mini-BESTest) (time frame: Balance will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07274514, which also lists 1 linked publication.
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 13 Jul 2026.