Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-03-06 @ 2:00 AM
Study NCT ID:
NCT02100592
Status:
COMPLETED
Last Update Posted:
2014-04-01
First Post:
2014-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Verticalization in neuroICU With ERIGO: a Safety and Feasibility Study
Sponsor:
Ospedale Generale Di Zona Moriggia-Pelascini
Organization:
Study Overview
Official Title:
Early Verticalization in neuroICU With ERIGO: a Safety and Feasibility Study
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: