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

April 29, 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

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

50

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Instituto de Investigación Sanitaria Aragón

Collaborators

Universidad de Zaragoza
Universidad San Jorge

Investigators

  • 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)

February 5, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

August 21, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Actual)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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