Robotic vs. Traditional Verticalization in Patients With Severe Acquired Brain Injury: a Randomized Controlled Trial
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
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
Treatments tested in this trial
- ErigoBasic or ErigoPro®
- Traditional Verticalization
Treatment groups
118 Participants
are divided into 2 treatment groupsSponsors and collaborators
Anna Estraneo
Lead sponsor
Fondazione Don Carlo Gnocchi Onlus
Sponsor institution
Istituti Clinici Scientifici Maugeri SpA
Collaborator
Ospedale Policlinico San Martino
Collaborator
Source ClinicalTrials.gov