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

ConditionAcquired 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Khymeia®-Virtual Reality rehabilitation System (VRRS EVO SYSTEM or COMPACT VRRS ENGINE)
Device
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.
Traditional cognitive training (TCT)
Behavioral
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

Treatment groups

28 Participants

are divided into 2 treatment groups

Group A: Non-immersive VR-based training (VR)Experimental treatment 1 intervention

Group B: Traditional cognitive training (TCT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Trail Making Test (B-A score)

The TMT is a neuropsychological test assessing executive functions. Higher scores indicate a better performance

Time frame

5 weeks

Secondary outcomes

Trail Making Test (B-A score)

The TMT is a neuropsychological test assessing executive functions. Higher scores indicate a better performance

Time frame

1 month after treatment

modified Barthel Index

It is a measure of functional disability, with higher scores indicating higher functional independence

Time frame