Virtual Reality vs Traditional Cognitive Training in Patients With Severe Acquired Brain Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAnna Estraneo

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

28 Participants
are divided into 2 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