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

RecruitingNAAges 18 Years - 75 YearsAllAnna Estraneo
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 \[1\]; * Not recovered upright station; * Written informed consent by the patient's legal rep-resentative/primary caregiver. Exclusion Criteria: * 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; * Contraindications to the use of Erigo®Basic and/or Eri-go®Pro (Hocoma, Volketswil, Switzerland) as per technical data sheet (see Appendix A); * Presence of prohibited drugs
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What it tests

  • ErigoBasic or ErigoPro®
  • Traditional Verticalization
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Where

6 sites
Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS
Sant'Angelo dei Lombardi, Italy
IRCCS Maugeri Bari
Bari, Italy
IRCCS Maugeri Telese Terme
Telese Terme, Italy
Ospedale Policlinico San Martino
Genova, Italy
IRCCS "S. Maria Nascente" - Fondazione Don Gnocchi
Milan, Italy
ICS Maugeri
Pavia, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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