Virtual Reality vs Traditional Cognitive Training in Patients With Severe Acquired Brain Injury
Multicentric Study on Implementation of Virtual Reality for Rehabilitation of Cognitive Functions in Patients With Severe Acquired Brain Injury: a Randomized Controlled Trial
Anna Estraneo
28 participants
Oct 28, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria7
- LCF ≥4 at study entry;
- Age 18-75
- Stable clinical diagnosis (i.e., stable LCF);
- Time post-injury between 28 days and 6 months;
- Ability to complete the pre-test A section of the Italian version of the Trail Making Test (TMT);
- A pathological B-A score of the TMT according to normative data adjusted for age and education;
- Signed informed consent by the patient or by the patient's primary caregiver.
Exclusion Criteria2
- 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)
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Interventions
fully immersive VR software created by clinicians and experts specialized in cognitive rehabilitation. Khymeia Devices are Medical Class 1 devices according to MDR. VRRS systems consist of a central process unit, complete with a capacitive touch screen LCD monitor.
face-to-face approach between the therapist and the patient using paper and pencil tools and other traditional materials. The training of the executive abilities is carried out by working on categorization, planning, association processes, analogical reasoning, problem solving and coping strategies to simulate problematic situations, tailored on patients' deficits
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06474871