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

Instituto de Investigación Sanitaria Aragón

Status: Enrolling

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

Treatments: Other: Immersive Virtual Reality Program; Other: Standard Rehabilitation Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07274514

UZ-USJ-PD

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Intervention Group. Immersive Virtual Reality Rehabilitation Program

Experimental group

Description:

The participants in the experimental group will receive a immersive virtual reality rehabilitation program to improve static and dynamic balance and quality of life.

Treatment:

Other: Immersive Virtual Reality Program

Control Group. Standard Rehabilitation Program

Active Comparator group

Description:

The participants in the control group will receive a standard physical therapy rehabilitation program to improve static and dynamic balance and quality of life

Treatment:

Other: Standard Rehabilitation Program