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

Ospedale Generale Di Zona Moriggia-Pelascini

Status and phase: Completed; Phase 2; Phase 1

Conditions: Brain Injury

Treatments: Other: Early rehabilitation treatment on Erigo Hocoma

Study type: Interventional

Funder types: Other

Identifiers

NCT02100592

ERIGO-1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 8 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Erigo treated

Experimental group

Description:

Early rehabilitation treatment on Erigo Hocoma, a tilt table with integrated stepping device within 3 - 30 days from injury

Treatment:

Other: Early rehabilitation treatment on Erigo Hocoma

Other: Early rehabilitation treatment on Erigo Hocoma