Trials. 2025 Oct 8;26(1):392. doi: 10.1186/s13063-025-09128-7.
ABSTRACT
BACKGROUND: After a severe acquired brain injury (sABI), individuals might experience mild-to-severe cognitive impairments. In these patients, cognitive rehabilitation is provided as early as possible, to take advantage of and guide brain plasticity. According to a restorative approach, traditional cognitive training (TCT) usually involves repeated paper-and-pencil exercises of increasing difficulty and targeting specific cognitive domains. Recently, some evidence supported the use of virtual reality (VR) for ABI rehabilitation, particularly focusing on stroke cases. Nonetheless, there is limited evidence in sABI and in different etiologies. The present multicenter randomized controlled trial aims at exploring the effectiveness, in terms of clinical-functional, neurophysiological, and biomarker changes, of a cognitive rehabilitation focused on executive functions performed by a non-immersive VR device, compared to TCT, in a cohort of patients with sABI.
METHODS: According to an a priori power analysis, 28 adult patients with sABI will be enrolled by 5 Italian neurorehabilitation units within the Fit for Medical Robotics ( https://www.fit4medrob.it/ ) Consortium. Patients will be randomly assigned to receive either 30 min of VR or TCT sessions each day throughout the trial. At study entry (T0), patients will undergo clinical-functional evaluation, neurophysiological assessments, and serum blood sampling. Thereafter, VR or TCT will be provided daily, five times per week, for 5 weeks (25 total treatment sessions). Clinical-functional and neurophysiological assessments will be repeated at the end of the treatment (T1). A follow-up evaluation will be performed after 1 month from T1 (T2). Statistical analyses will be conducted blindly, according to the intention-to-treat principle.
DISCUSSION: VR has recently been gaining popularity as a cognitive rehabilitation tool. Notwithstanding substantial evidence supporting the use of VR for ABI rehabilitation, there is limited evidence in sABI from traumatic or anoxic etiology. This multicenter pragmatic trial will provide new insights into the effectiveness of VR in sABI cognitive rehabilitation.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06474871. Registered on December 2, 2024.
PMID:41063192 | DOI:10.1186/s13063-025-09128-7
