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Robotic vs. Traditional Verticalization in Patients With Severe Acquired Brain Injury: a Randomized Controlled Trial
Sponsor: Anna Estraneo
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 plus mobilization (VEM) versus traditional verticalization (TV) in a large cohort of patients with sABI.
Official title: Multicentric Study on Combined Verticalization and Mobilization in Patients With Severe Acquired Brain Injury: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
118
Start Date
2024-12-02
Completion Date
2026-11-30
Last Updated
2025-11-20
Healthy Volunteers
No
Interventions
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.
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)
Locations (6)
Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS
Sant'Angelo dei Lombardi, Avellino, Italy
IRCCS Maugeri Telese Terme
Telese Terme, BN, Italy
IRCCS "S. Maria Nascente" - Fondazione Don Gnocchi
Milan, Milan, Italy
IRCCS Maugeri Bari
Bari, Italy
Ospedale Policlinico San Martino
Genova, Italy
ICS Maugeri
Pavia, Italy