Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients

Summary

The purpose of this clinical study is to evaluate the feasibility, usability, and motivational impact of VirtualPark, a virtual reality-based dual-task rehabilitation system, in adults with neurological and age-related conditions.

VirtualPark is a virtual reality application designed to deliver cognitive exercises during cycling training using a commercially available ergometer (THERA-Trainer Tigo). The system integrates physical and cognitive tasks in simulated real-life environments.

The intervention integrates motor and cognitive training tasks targeting domains such as attention, inhibition, working memory, and navigation.

This is a prospective, multicenter, randomized, cross-over pilot study. It will compare cycling training performed with and without virtual reality. Participants will complete both intervention conditions over a 4-week period separated by a wash-out phase with standard rehabilitation activities. The order of conditions will be randomized.

The study will assess motivation during rehabilitation training, usability and user experience of the system, as well as exploratory effects on cognitive and motor performance, functional abilities, perceived exertion, and safety.

The study will enroll adult participants (≥18 years) with conditions such as stroke, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, mild cognitive impairment, spinal cord injury, and frail older adults.

Conditions

• Post-stroke
• Parkinson Disease
• Amyotrophic Lateral Sclerosis
• Mild Cognitive Impairment (MCI)
• Multiple Sclerosis
• Frailty at Older Adults

Interventions

DEVICE

Dual-task training with Virtual Reality

Participants perform cycling training using a commercially available ergometer combined with a non-immersive virtual reality system. Virtual Reality offers cognitive exercises targeting attention, inhibition, working memory, and navigation during cycling.

DEVICE

Cycling training

Participants perform standard cycling training without virtual reality-based tasks

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA

  collaborator OTHER

• Villa Beretta Rehabilitation Center

  collaborator OTHER

• University of Pisa

  collaborator OTHER

• Marta Mondellini

  lead OTHER

Principal Investigators

• Marta Mondellini, Psychologist · Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato

• Cira Fundarò, MD · Istituti Clinici Scientifici Maugeri IRCCS Montescano

• Christian Lunetta, MD · Istituti Clinici Scientifici Maugeri IRCCS Milano Camaldoli

• Stefania De Trane, MD · Istituti Clinici Scientifici Maugeri IRCCS Bari

• Laura Marcuccio, MD · Istituti Clinici Scientifici Maugeri IRCCS Telese

• Chiara Pavese, MD · Istituti Clinici Scientifici Maugeri IRCCS Pavia

• Franco Molteni, MD · Centro di Riabilitazione Villa Beretta

• Carmelo Chisari, MD · University of Pisa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2026-12-31

Completion

2027-01-31

Countries

• Italy

Study Locations