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

March 27, 2014 updated by: Ospedale Generale Di Zona Moriggia-Pelascini
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erigo treated
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events during verticalization
Time Frame: 21 days: from T1 (first session) to T15 (last session)

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
Time Frame: 21 days: from T1 (first session) to T15 (last session)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

Investigators

  • Study Chair: Giuseppe Frazzitta, MD, Ospedale generale di zona 'Moriggia Pelascini'
  • Principal Investigator: Roberto Valsecchi, MD, Ospedale generale di zona 'Moriggia Pelascini'
  • Principal Investigator: Leopold Saltuari, MD, LDK Hochzirl
  • Principal Investigator: Luca Sebastianelli, MD, Ospedale generale di zona 'Moriggia Pelascini'

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

March 27, 2014

First Posted (Estimate)

April 1, 2014

Study Record Updates

Last Update Posted (Estimate)

April 1, 2014

Last Update Submitted That Met QC Criteria

March 27, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERIGO-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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