Virtual Reality on Balance of Parkinson's Disease

NCT07274514 | Active Not Recruiting

• 1 other identifier: UZ-USJ-PD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Immersive Virtual Reality; Balance; Physical Therapy; Quality of life; Gait; Strength; parkinson's disease; virtual reality

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  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)

  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)

  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):

  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

  Quality of life will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).

Study Arms (2)

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.

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

Other: Standard Rehabilitation Program

Interventions

Immersive Virtual Reality Program 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

Intervention Group. Immersive Virtual Reality Rehabilitation Program

Standard Rehabilitation Program 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

Control Group. Standard Rehabilitation Program

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead
• Universidad San Jorge: collaborator
• Universidad de Zaragoza: collaborator

Study Sites (1)

Asociación de Parkinson de Aragón

Zaragoza, Spain

Location

Related Publications (1)

• 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.

  PMID: 41838745 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Sandra Calvo, PhD

  Universidad de Zaragoza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single Blind (Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Single-blind randomized clinical trial with two parallel interventions

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: December 10, 2025
• Study Start: February 5, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2025-10

Locations

ES (1)