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RECRUITING
NCT06474871
NA

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

Sponsor: Anna Estraneo

View on ClinicalTrials.gov

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).

Official title: Multicentric Study on Implementation of Virtual Reality for Rehabilitation of Cognitive Functions in Patients With Severe Acquired Brain Injury: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2024-10-28

Completion Date

2026-11-30

Last Updated

2025-09-29

Healthy Volunteers

No

Interventions

DEVICE

Khymeia®-Virtual Reality rehabilitation System (VRRS EVO SYSTEM or COMPACT VRRS ENGINE)

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.

BEHAVIORAL

Traditional cognitive training (TCT)

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)

Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS

Sant'Angelo dei Lombardi, Avellino, Italy

ICS Maugeri

Telese Terme, Benevento, Italy

IRCCS Santa Maria Nascente Fondazione Don Gnocchi ONLUS

Milan, Italy