BACKGROUND: In neurorehabilitation, the use of innovative technologies offers many opportunities to monitor and to improve the health status of patients with acquired brain injury (SABI) patients. Telerehabilitation allows for continuity of service through the entire rehabilitation cycle including assessment, intervention, consultation and education, affording early reintegration and positively enhancing quality of life. OBJECTIVE: The main purpose of this multicenter randomised control trial was to test the effect of an advanced training with a non-immersive virtual reality rehabilitation system (ie, the VRRS-Home-Kit device) in improving functional outcomes in patients affected by SABI. METHODS: Forty SABI patients and their caregivers attending two Italian rehabilitation Centres, were enrolled in the study protocol and randomised in two groups. Twenty patients received the experimental training using the VRRS-HomeKit (Tele-Neuro VRRS) whereas the other twenty were submitted to usual territorial rehabilitative treatments (UTRT). To investigate motor and neuropsychological functioning, SABI patients were evaluated before (T0) and at the end (T1) of each training by a multispecialist team through a complete clinical and psychometric battery, including: Barthel Index (BI), Tinetti Scale (TS), Modified Ashworth Scale (MAS), Montreal Cognitive Assessment (MoCa), Frontal Assessment Battery (FAB), Beck Depression Inventory II (BDI-II), Short Form Health Survey 36 (SF-36) and The Psychological General Well-Being Index (PGWBI). In addition, the Caregiver Burden Inventory (CBI) was administered to each caregiver, to investigate the emotional burden status. RESULTS: The experimental group achieved a statistically significant improvement in both general and motor outcomes, as well as psychological well-being and quality of life, as compared to the control group. In particular, Barthel Index (p < 0.001), Frontal Assessment Battery (p < 0.001), and Beck Depression Inventory (p < 0.001) were the outcome scales with the best improvement. The burden of caregivers also significantly improved in the Tele neuro-VRRS group (CBI, p < 0.004). Between-group analysis showed statistical differences in Anxiety (p < 0.02, ES 0.85) and Self Control (p < 0.03, ES 0.40) subtests of the PGWBI, and social role functioning (p < 0.02, ES 0.85) subtest of SF-36 confirmed also by quite medium and large effect sizes. CONCLUSIONS: Our results suggest that VRRS is a suitable alternative and/or complementary tool to improve motor (level of functional independence) and cognitive (frontal/executive abilities) outcomes, reducing behavioural alterations (anxiety and depression symptoms) in SABI patients, with a beneficial impact also on the caregivers' burden distress management, mitigating distress and promoting positive aspects of caring. CLINICALTRIAL: NCT03709875 registered on ClinicalTrials.gov.

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