Visuo-Vestibular VR-based Stimulation Effects on Balance and Gait in Stroke Survivors
Launched by I.R.C.C.S. FONDAZIONE SANTA LUCIA · Jan 13, 2025
Trial Information
Current as of August 21, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a special virtual reality (VR) rehabilitation program on improving balance and walking for people who have had a stroke. The study will involve 38 participants who are at least six months post-stroke and between the ages of 18 and 80. To be eligible, participants need to have good mental clarity—meaning they can understand instructions—and should be able to walk with some assistance. Those with other serious health issues that could complicate their participation will not be included.
Participants will be divided into two groups: one will receive the real VR training designed to stimulate their balance and coordination, while the other will experience a similar VR program without the specific balance exercises. Over 12 sessions, held three times a week for about 20 minutes each, trained physiotherapists will guide them through the program. The researchers will check how well the program works by assessing balance, walking ability, and overall quality of life before the treatment starts, after it ends, and again a month later. This study will help determine if VR technology can be an effective tool in rehabilitation for stroke survivors.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Subjects with a history of hemorrhagic or ischemic stroke (more than 6 months from the acute event)
- • Patients aged between 18 and 80 years
- • Absence of cognitive deficits that may interfere with the patient's ability to understand the exercise instructions (MiniMentalState Evaluation \> 24)
- • Functional Ambulation Category ≥ 3
- • Absence of associated orthopedic, visual, and/or neurological issues (clinically assessed) that may affect participation in the study
- Exclusion Criteria:
- • Patients with stroke (less than 6 months from the acute event);
- • Patients aged under 18 and over 80;
- • Presence of associated orthopedic, visual, and/or neurological issues (clinically assessed) that may affect participation in the study;
- • Presence of cognitive deficits that may interfere with the patient's ability to understand the exercise instructions (MiniMentalState Evaluation ≤ 24);
- • Epilepsy.
About I.R.C.C.S. Fondazione Santa Lucia
i.r.c.c.s. Fondazione Santa Lucia is a leading Italian research institute dedicated to advancing scientific knowledge in the fields of neuroscience, rehabilitation, and health sciences. As a clinical trial sponsor, the foundation is committed to conducting high-quality research aimed at improving patient outcomes and enhancing the understanding of neurological disorders. With a multidisciplinary team of experts and state-of-the-art facilities, Fondazione Santa Lucia fosters collaboration between researchers, healthcare professionals, and industry partners to translate innovative findings into effective therapeutic strategies and interventions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roma, Rm, Italy
Patients applied
Trial Officials
Jacopo Piermaria
Principal Investigator
Fondazione Santa Lucia IRCCS
Diego Piatti, PT
Study Chair
Fondazione Santa Lucia IRCCS
Sara De Angelis, MSc
Study Chair
Fondazione Santa Lucia IRCCS
Roberta Annicchiarico, MD
Study Chair
Fondazione Santa Lucia IRCCS
Matteo Marucci, PhD
Study Chair
Department of Psychology, Sapienza University of Rome, Rome, Italy; Laboratory of Neuroscience and Applied Technology, Santa Lucia Foundation IRCCS, Rome, Italy.
Viviana Betti, Prof.
Study Chair
Department of Psychology, Sapienza University of Rome, Rome, Italy; Laboratory of Neuroscience and Applied Technology, Santa Lucia Foundation IRCCS, Rome, Italy.
Marco Tramontano, Prof
Study Director
Department of Biomedical and Neuromotor Sciences, University of Bologna, 40138 Bologna, Italy.; Unit of Occupational Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported