Brain Injury
Conditions
Keywords
brain injury, coma, intensive care, early rehabilitation
Brief summary
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.
Detailed description
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).
Interventions
OTHEREarly rehabilitation treatment on Erigo Hocoma
5 weekly sessions of erigo for three weeks. Expected tilt angle up to 60 °
Sponsors
Ospedale Generale Di Zona Moriggia-Pelascini
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patient / a severe acquired brain injury occurred 3 to 30 days prior to enrollment 2. Age between 18 and 75 years 3. Glasgow Coma Scale ≤ 8 at entrance in ICUs 4. Adequate respiratory exchange with PaO2/FiO2 ≥ 250 5. Absence of sedation increased
Exclusion criteria
1. Major chest trauma with multiple rib fractures and / or pneumothorax 2. Presence of fractures, vascular lesions, skin lesions with loss of substance in the abdomen, pelvis or lower limb 3. Cardiovascular instability despite support with amines 4. Intracranial pressure (ICP)\> 25 mm / Hg 5. Cerebral Perfusion Pressure (PPC) \<60 mm / Hg 6. Severe kidney failure requiring replacement therapy 7. Decompensated liver disease 8. Hematocrit value of ≤ 30% 9. Body weight\> 135 kg or height\> 210 cm 10. Deep vein thrombosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events during verticalization | 21 days: from T1 (first session) to T15 (last session) | 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; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of hemodynamic parameters | 21 days: from T1 (first session) to T15 (last session) | 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. |
Outcome results
None listed