Early Stepping Verticalization in ICU for ABI Patients
Brain Injury, Consciousness Disorders
About this trial
This is an interventional supportive care trial for Brain Injury
Eligibility Criteria
Inclusion Criteria:
- Glasgow Coma Scale (GCS) ≤8 for ≥24h from the event;
- diagnosis of vegetative state or minimally conscious state on the third day after the injury;
- adequate pulmonary gas exchanging function;
- stable hemodynamics
Exclusion Criteria:
- sedation;
- unstable intracranial pressure (ICP);
- cerebral perfusion pressure (CPP) <60 mmHg;
- fractures or skin lesions in thorax, abdomen or lower limbs;
- deep vein thrombosis;
- body weight >130 kg; height >210 cm.
Sites / Locations
- Ospedale Generale di Zona "Moriggia Pelascini"
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Erigo
Conventional
Single daily sessions of verticalization, using a tilt table with an integrated robotic stepping device (Erigo. Hocoma AG, Switzerland) located in the ICU room. Sessions were performed five times per week (Monday-Friday) for three consecutive weeks (a total of 15 sessions per patient). On the same days the patients received conventional physiotherapy for 30 minutes a day. Before the verticalization period the experimental group received conventional in-bed physiotherapy for 60 minutes a day.
treated with conventional in-bed physiotherapy for 60 minutes a day, from Monday to Friday, throughout the ICU stay.