NCT02100592

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Brain Injury

Interventions

Type	Name	Description
OTHER	Early rehabilitation treatment on Erigo Hocoma	5 weekly sessions of erigo for three weeks. Expected tilt angle up to 60 °
OTHER	Early rehabilitation treatment on Erigo Hocoma	Early verticalization treatment with Erigo Hocoma, a tilt table with stepping system

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-02-01
• Completion: 2014-03-01
• First posted: 2014-04-01
• Last updated: 2014-04-01