Early Verticalization in neuroICU With ERIGO: a Safety and Feasibility Study

Study Overview
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Brief Summary
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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
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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).

Official Title
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Early Verticalization in neuroICU With ERIGO: a Safety and Feasibility Study

Conditions
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Brain Injury

Intervention / Treatment
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* Other: Early rehabilitation treatment on Erigo Hocoma
* Other: Early rehabilitation treatment on Erigo Hocoma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient / a severe acquired brain injury occurred 3 to 30 days prior to enrollment Age between 18 and 75 years Glasgow Coma Scale ≤ 8 at entrance in ICUs Adequate respiratory exchange with PaO2/FiO2 ≥ 250 Absence of sedation increased Exclusion Criteria: Major chest trauma with multiple rib fractures and / or pneumothorax Presence of fractures, vascular lesions, skin lesions with loss of substance in the abdomen, pelvis or lower limb Cardiovascular instability despite support with amines Intracranial pressure (ICP)> 25 mm / Hg Cerebral Perfusion Pressure (PPC) <60 mm / Hg Severe kidney failure requiring replacement therapy Decompensated liver disease Hematocrit value of ≤ 30% Body weight> 135 kg or height> 210 cm Deep vein thrombosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erigo treated<br>Early rehabilitation treatment on Erigo Hocoma, a tilt table with integrated stepping device within 3 - 30 days from injury | Other: Early rehabilitation treatment on Erigo Hocoma<br>* 5 weekly sessions of erigo for three weeks. Expected tilt angle up to 60 °<br>Other: Early rehabilitation treatment on Erigo Hocoma<br>* Early verticalization treatment with Erigo Hocoma, a tilt table with stepping system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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; | 21 days: from T1 (first session) to T15 (last session) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 21 days: from T1 (first session) to T15 (last session) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain injury, coma, intensive care, early rehabilitation