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

NCT02100592 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2014-04-01

No results posted yet for this study

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.

Conditions

  • Brain Injury

Interventions

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

Sponsors & Collaborators

  • Ospedale Generale Di Zona Moriggia-Pelascini

    lead OTHER

Principal Investigators

  • Giuseppe Frazzitta, MD · Ospedale generale di zona 'Moriggia Pelascini'

  • Roberto Valsecchi, MD · Ospedale generale di zona 'Moriggia Pelascini'

  • Leopold Saltuari, MD · LDK Hochzirl

  • Luca Sebastianelli, MD · Ospedale generale di zona 'Moriggia Pelascini'

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-02-28
Completion
2014-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02100592 on ClinicalTrials.gov