ClinConnect ClinConnect Logo
Search / Trial NCT06780488

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

Stroke Vestibular Rehabilitation Virtual Reality Balance Gait Quality Of Life

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.

Locations

Roma, Rm, Italy

Patients applied

0 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