Early Stepping Verticalization in ICU for ABI Patients

July 6, 2016 updated by: Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini

Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: a Randomized Pilot Study in ICU

Verticalization was reported to improve the level of arousal and awareness in patients with severe acquired brain injury (ABI) and to be safe in ICU. The investigators evaluated the effectiveness of a very early stepping verticalization protocol on the functional and neurological outcome of patients affected by disorder of consciousness due to ABI.

Consecutive patients with Vegetative State or Minimally Conscious State were enrolled in ICU on the third day after an ABI. They were randomized to undergo conventional physiotherapy alone or associated to fifteen 30-minute sessions of verticalization, using a tilt table with robotic stepping device. Once stabilized, patients were transferred to a Neurorehabilitation unit for an individualized treatment. Outcome measures were assessed on the third day from the injury (T0), at ICU discharge (T1) and at Rehab discharge (T2).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • CO
      • Gravedona ed Uniti, CO, Italy, 22015
        • Ospedale Generale di Zona "Moriggia Pelascini"

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Glasgow Coma Scale (GCS) ≤8 for ≥24h from the event;
  • diagnosis of vegetative state or minimally conscious state on the third day after the injury;
  • adequate pulmonary gas exchanging function;
  • stable hemodynamics

Exclusion Criteria:

  • sedation;
  • unstable intracranial pressure (ICP);
  • cerebral perfusion pressure (CPP) <60 mmHg;
  • fractures or skin lesions in thorax, abdomen or lower limbs;
  • deep vein thrombosis;
  • body weight >130 kg; height >210 cm.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erigo
Single daily sessions of verticalization, using a tilt table with an integrated robotic stepping device (Erigo. Hocoma AG, Switzerland) located in the ICU room. Sessions were performed five times per week (Monday-Friday) for three consecutive weeks (a total of 15 sessions per patient). On the same days the patients received conventional physiotherapy for 30 minutes a day. Before the verticalization period the experimental group received conventional in-bed physiotherapy for 60 minutes a day.
Device: stepping verticalization
After patient positioning, the slope of the tilt table was gradually increased from 0° to 20°, 40° and then 60° in a time span of nine minutes. The stepping frequency was set at 20 steps/min for the entire treatment. Cardiovascular and respiratory parameters were continuously monitored. The net time of the session was 30 minutes
Active Comparator: Conventional
treated with conventional in-bed physiotherapy for 60 minutes a day, from Monday to Friday, throughout the ICU stay.
Other: conventional mobilization
in-bed physiotherapy (mobilization exercises in supine and sitting position on bed, without out-of-bed mobilization nor verticalization)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Coma Recovery Scale change
Time Frame: through study completion, average 18 weeks
through study completion, average 18 weeks
Glasgow Coma Scale change
Time Frame: through study completion, average 18 weeks
through study completion, average 18 weeks
Levels of Cognitive Functioning change
Time Frame: through study completion, average 18 weeks
through study completion, average 18 weeks
Disability Rating Scale change
Time Frame: through study completion, average 18 weeks
through study completion, average 18 weeks

Collaborators and Investigators

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

Sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 2, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Estimate)

July 11, 2016

Last Update Submitted That Met QC Criteria

July 6, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Erigo_eff

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Subscribe