Robotic vs. Traditional Verticalization in Patients With Severe Acquired Brain Injury: a Randomized Controlled Trial
NCT Number: NCT06469983
Acronym: VEM-sABI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acquired Brain Injury|Disorder of Consciousness
Interventions: DEVICE: ErigoBasic or ErigoPro®|BEHAVIORAL: Traditional Verticalization
Sponsor: Anna Estraneo
Collaborators: Istituti Clinici Scientifici Maugeri SpA|Ospedale Policlinico San Martino
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 198
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-07-30
Locations: Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS, Sant'Angelo Dei Lombardi, Avellino, 83054, Italy

Summary:
In the rehabilitation project for patients with severe Acquired Brain Injury (sABI), it is essential to include exercises that facilitate the recovery of the upright position (or verticalization). Recently, tilt-table equipped with the robot-assisted lower limbs cyclic mobilization has been proposed as a safe and suitable device for accelerating the adaptation to vertical posture in bedridden patients with brain-injury since the acute phase. The present multicentre study aims at evaluating the effectiveness of robotic assisted verticalization (RV) versus traditional verticalization (TV) in a large cohort of patients with sABI.

Primary Outcome Measures: Coma Recovery Scale-Revised, A clinical scale assessing the level of consciousness in patients with disorders of consciousness. Higher scores indicate a higher level of consciousness, 5 weeks|Levels of cognitive functioning, A clinical scale assessing global cognitive functioning in patients emerged from a disorder of consciousness. Higher scores indicate a higher cognitive functioning, 5 weeks
Secondary Outcome Measures: Coma Recovery Scale-Revised, A clinical scale assessing the level of consciousness in patients with disorders of consciousness. Higher scores indicate a higher level of consciousness, 1 month after treatment|Levels of cognitive functioning, A clinical scale assessing global cognitive functioning in patients emerged from a disorder of consciousness. Higher scores indicate a higher cognitive functioning, 1 month after treatment|Modified Ashworth scale, A clinical scale assessing spasticity. Higher scores indicate a more severe spasticity, 5 weeks - 1 month after treatment|Medical Research Council Scale, A clinical scale assessing muscle functioning. Higher scores indicating a better functioning, 5 weeks - 1 month after treatment|modified Barthel Index, It is a measure of functional disability, with higher scores indicating higher functional independence, 5 weeks - 1 month after treatment|Disability Rating Scale, It is a measure of functional disability, with higher scores indicating higher disability, 5 weeks - 1 month after treatment|System Usability Scale, It is a measure of usability and compliance. Higher scores indicate a better performance, 5 weeks - 1 month after treatment
Other Outcome Measures: Spectral metrics, Measure of quantitative EEG. Higher values indicate a better functional connectivity, 5 weeks - 1 month after treatment|Microstate metrics, Measure of quantitative EEG. Higher values indicate a better functional connectivity, 5 weeks - 1 month after treatment|Connectivity metrics, Measure of quantitative EEG. Higher values indicate a better functional connectivity, 5 weeks - 1 month after treatment|Brain-derived neurotrophic factor, Blood biomarker. Higher value indicate higher brain plasticity, 5 weeks - 1 month after treatment|Neurofilament-Light, Blood biomarker. Higher value indicate higher brain plasticity, 5 weeks - 1 month after treatment|Glial fibrillary acidic protein, Blood biomarker. Higher value indicate higher brain plasticity, 5 weeks - 1 month after treatment|Fondazione Don Gnocchi-Clinical Complications Scale, A clinical scale assessing clinical complications. Higher scores indicate more and more severe clinical complications, 5 weeks - 1 month after treatment