Combined Robotic VErticalization and Lower Limb Mobilization in Patients with Severe Acquired Brain Injury: Protocol of a Multicenter Randomized Controlled Trial (VEM-sABI).

Abstract

Background: Upright position recovery (i.e., verticalization) is crucial in the rehabilitation of severe acquired brain injury (sABI). VErticalization by tilt table equipped with robotic-assisted lower limbs cyclic Mobilization (VEM) may facilitate a safer adaptation to vertical posture, reducing orthostatic hypotension occurrence. This multicenter randomized controlled trial (RCT) aims at investigating efficacy, safety, and usability of VEM compared to Traditional Verticalization (TV) using a conventional tilt table in cognitive-motor rehabilitation of sABI patients; Methods: a total of 118 sABI patients with or emerged from prolonged Disorder of Consciousness (pDoC and eDoC) will be enrolled in six post-acute Neurorehabilitation Units and randomly allocated to VEM or TV arm (for each arm: total 25 sessions of 30 min daily treatment/5 days/week/5 weeks). Patients will undergo clinical-functional assessment, resting EEG recording and blood sampling, before, at the end of treatment, and after 1 month; Results: we will expect possible differences in safety and usability of verticalization between VEM and TV rehabilitative intervention and in their efficacy to improve clinical-functional findings and brain indices; Conclusions: this RCT will provide new insights for the intensive, tailored and safe neurorehabilitation intervention in patients with sABI.