Robotic vs. Traditional Verticalization in Patients With Severe Acquired Brain Injury: a Randomized Controlled Trial

ConditionsAcquired Brain Injury Disorder of Consciousness

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorAnna Estraneo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 75 years;

sABI due to traumatic, vascular, anoxic, or mixed etiology;

Stable behavioral/cognitive diagnosis on at least 4 behavioral evaluations in 1 week using the Italian version of the CRS-R in patients with pDoC, or the LCF-based cognitive assessment in patients with eDoC;

Time post-injury between 28 days and 6 months [1];

Disqualifiers

Severe medical conditions hampering verticalization (e.g., severe hypotension or conditions realizing hemodynamic instability, end stage or severe symptomatic heart failure with reduced ejection fraction, cardiac arrhythmia of new diagnosis or arrhythmic flare, severe hepatic failure, chronic severe lower limb arterio-venous disease, sep-sis/septic shock, thrombus venous embolism of new diag-nosis, severe autonomic dysreflexia);

Severe medical conditions hampering lower limb mobili-zation (e.g., fractures, heterotopic ossifications);

Severe medical conditions impacting EEG activity (e.g., sub-continuous or abundant EEG epileptiform abnormali-ties);

Severe medical conditions influencing conscious-ness/cognitive status, such as severe hyponatremia or hy-poglycemia;

Trial design

Design model

Parallel

Treatments tested in this trial

ErigoBasic or ErigoPro®
Device
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
Behavioral
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)

Treatment groups

118 Participants

are divided into 2 treatment groups

Group A: Robotic VerticalizationExperimental treatment 1 intervention

Group B: Traditional VerticalizationActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

5 weeks