Virtual Reality on Balance of Parkinson's Disease (RVI-PD)

July 10, 2026 updated by: Sandra Calvo Carrión, Instituto de Investigación Sanitaria Aragón

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Lorena Morcillo, Phd Student
  • Phone Number: +34 647 990 253
  • Email: lmorcillo@usj.es

Study Contact Backup

Study Locations

  • Spain
      • Zaragoza, Spain
        • Asociación de Parkinson de Aragón

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group. Immersive Virtual Reality Rehabilitation Program
The participants in the experimental group will receive a immersive virtual reality rehabilitation program to improve static and dynamic balance and quality of life.
Other: Immersive Virtual Reality Program
The participants in the intervention group will receive a Immersive Virtual Reality Rehabilitation Program to improve static and dynamic balance and quality of life
Active Comparator: Control Group. Standard Rehabilitation Program
The participants in the control group will receive a standard physical therapy rehabilitation program to improve static and dynamic balance and quality of life
Other: Standard Rehabilitation Program
The participants in the control group will receive a Standard Physical Therapy Rehabilitation Program to improve static and dynamic balance and quality of life

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Balance will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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.
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).
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
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).
Assess the functional mobility during walking, as well as the risk of falling
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).
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)
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).
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.
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.
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.
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.
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.
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).
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.
Satisfaction with Immersive Virtual Realiity program will be assessed at two time points: the day post-intervention (M1), and 90 days post-intervention (M2).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto de Investigación Sanitaria Aragón

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad de Zaragoza
Universidad San Jorge

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sandra Calvo, PhD, Universidad de Zaragoza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 27, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 12, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UZ-USJ-PD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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