Virtual Reality on Balance of Parkinson's Disease

NCT ID: NCT07274514

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-05
• Study Completion Date: 2026-05-31

Brief 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. 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).

Conditions

Parkinson Disease (PD); Immersive Virtual Reality; Physical Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Immersive Virtual Reality Program

Intervention Type: OTHER

The participants in the intervention group will receive a Immersive Virtual Reality Rehabilitation Program to improve static and dynamic balance and quality of life

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

Group Type: ACTIVE_COMPARATOR

Standard Rehabilitation Program

Intervention Type: OTHER

The participants in the control group will receive a Standard Physical Therapy Rehabilitation Program to improve static and dynamic balance and quality of life

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad San Jorge

OTHER

Sponsor Role: collaborator

Universidad de Zaragoza

OTHER

Sponsor Role: collaborator

Instituto de Investigación Sanitaria Aragón

OTHER

Sponsor Role: lead

Responsible Party

Sandra Calvo Carrión

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandra Calvo, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Zaragoza

Locations

Asociación de Parkinson de Aragón

Zaragoza, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Lorena Morcillo, Phd Student

Role: CONTACT

lmorcillo@usj.es

+34 647 990 253

Sandra Calvo, PhD

Role: CONTACT

sandracalvo@unizar.es

• +34 661 833 194

Other Identifiers

UZ-USJ-PD

Identifier Type: -

Identifier Source: org_study_id