About this trial
Considerable evidence exists for using Virtual Reality (VR) for rehabilitation of acquired brain injury (ABI), with a particular focus on stroke. However, to date very little evidence has been collected in patients with ABI with different aetiologies (i.e., traumatic or anoxic brain injury) and level of severity (i.e., severe, sABI). The present multicentre study aims to overcome current literature issues as heterogeneity of populations and outcomes, small sample sizes and a lack of randomized controlled trials, which can affect the level of evidence and generalizability of results, to determine the effectiveness of a non immersive VR-based rehabilitation versus traditional cognitive training (TCT).
Eligibility criteria
Qualifiers
LCF ≥4 at study entry;
Age 18-75
Stable clinical diagnosis (i.e., stable LCF);
Time post-injury between 28 days and 6 months;
Disqualifiers
Severe medical conditions that might hamper participation in the rehabilitation sessions, or influence diagnosis;
Previous neurodegenerative or acquired neurological diseases that affect cognitive domains (e.g., dementia)
Trial design
Treatments tested in this trial
- Khymeia®-Virtual Reality rehabilitation System (VRRS EVO SYSTEM or COMPACT VRRS ENGINE)
- Traditional cognitive training (TCT)
Treatment groups
Sponsors and collaborators
Anna Estraneo
Lead sponsor
Fondazione Don Carlo Gnocchi Onlus
Sponsor institution
Istituti Clinici Scientifici Maugeri SpA
Collaborator
Ospedale Policlinico San Martino
Collaborator