Robotic Vs. Traditional Verticalization in Patients with Severe Acquired Brain Injury: a Randomized Controlled Trial

NARecruitingINTERVENTIONAL
Enrollment

198

Participants

Timeline

Start Date

December 2, 2024

Primary Completion Date

August 31, 2025

Study Completion Date

July 30, 2026

Conditions
Acquired Brain InjuryDisorder of Consciousness
Interventions
DEVICE

ErigoBasic or ErigoPro®

Static bed with integrated robotic stepper (ErigoBasic) and optionally integrated with Functional Electrical Stimulation (FES ErigoPro®). The Erigo is a robot designed to be used for early functional mobilisation of patients with neurological manifestations or who are bedridden, even in intensive care. It is a tilt table equipped with an integrated passive stepper controlled by microprocessors that generate physiological leg movements: the patient's thighs are secured by straps to the movement mechanisms and the feet are secured to plates equipped with shock absorbers, while the upper body is held in place by a sling integrated into the table. Erigo provides active functions: gradual elevation in orthostatism up to 90°, controlled and independent mobilisation of the lower limbs, and functional stimulation.

BEHAVIORAL

Traditional Verticalization

gradual verticalization (from supine position up to maximum 90°, in 3 steps), depending on the patient's vital signs compliance, using a traditional standing device (i.e., non-robotic traditional tilt table)

Trial Locations (2)

27100

RECRUITING

ICS Maugeri, Pavia

83054

RECRUITING

Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS, Sant'Angelo dei Lombardi

All Listed Sponsors
collaborator

Istituti Clinici Scientifici Maugeri SpA

OTHER

collaborator

Ospedale Policlinico San Martino

OTHER

lead

Anna Estraneo

OTHER