Severe brain injuries induce alteration of state of consciousness. These functional limitations can be significantly alleviated by treatment neurorehabilitation, particularly if this is established early. It has been shown that treatment of vertical integration in patients in a vegetative state or minimally conscious state can improve the level of supervision and positive influence on rehabilitation. Therefore, there are sufficient indications that anticipate the treatment of vertical integration, since the phase of hospitalization in ICUs, may improve the functional outcome of the patient.
Early verticalization and stepping with the equipment Hocoma Erigo, during monitoring of vital parameters. The device Erigo is already CE marked and, for the purposes of the study, will be used in accordance with the intended use of the same mark (after-market clinical investigation).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
5 weekly sessions of erigo for three weeks. Expected tilt angle up to 60 °
Early verticalization treatment with Erigo Hocoma, a tilt table with stepping system
Adverse events during verticalization
It is a composite outcome, assessing the occurence of at least one of the following conditions (component outcomes): Heart rate \<40 bpm or\> 150 bpm; Mean arterial pressure \<70 mmHg; Arterial oxygen saturation \<90%; Onset of ECG anomalies; Traumatic dislodgement of a device;
Time frame: 21 days: from T1 (first session) to T15 (last session)
Changes of hemodynamic parameters
Changes of hemodynamic parameters during each session and from T1 to T15; assessed parameters are: stroke volume; peripheral resistances; mean arterial pressure; cerebral perfusion pressure.
Time frame: 21 days: from T1 (first session) to T15 (last session)
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