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.
Informed consent to the study
subjects > 18 years and <85 years
diagnosis of MCI according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders VTh Edition (DSM V TR American Psychological Association 2013)
detection of ischemic stroke within 6 months preceding the study, frail elderly subjects (Gobbens RJ et al. 2010)
Other concomitant neurological pathologies in addition to the one under study
presence of visual disturbances that do not allow access to the experimental virtual reality protocol
presence of impaired cardiorespiratory function or other organic instabilities that contraindicate ergometer training
severe osteoporosis
Marta Mondellini
Lead sponsor
Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
Sponsor institution
Istituti Clinici Scientifici Maugeri SpA
Collaborator
Villa Beretta Rehabilitation Center
Collaborator
University of Pisa
Collaborator