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Early Stepping Verticalization in ICU for ABI Patients

Primary Purpose

Brain Injury, Consciousness Disorders

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
stepping verticalization
conventional mobilization
Sponsored by
Ospedale Generale Di Zona Moriggia-Pelascini
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ospedale Generale di Zona "Moriggia Pelascini"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Erigo

Conventional

Arm Description

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.

treated with conventional in-bed physiotherapy for 60 minutes a day, from Monday to Friday, throughout the ICU stay.

Outcomes

Primary Outcome Measures

Coma Recovery Scale change
Glasgow Coma Scale change
Levels of Cognitive Functioning change
Disability Rating Scale change

Secondary Outcome Measures

Full Information

First Posted
July 2, 2016
Last Updated
July 6, 2016
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
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1. Study Identification

Unique Protocol Identification Number
NCT02828371
Brief Title
Early Stepping Verticalization in ICU for ABI Patients
Official Title
Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: a Randomized Pilot Study in ICU
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini

4. Oversight

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury, Consciousness Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erigo
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
treated with conventional in-bed physiotherapy for 60 minutes a day, from Monday to Friday, throughout the ICU stay.
Intervention Type
Device
Intervention Name(s)
stepping verticalization
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
conventional mobilization
Intervention Description
in-bed physiotherapy (mobilization exercises in supine and sitting position on bed, without out-of-bed mobilization nor verticalization)
Primary Outcome Measure Information:
Title
Coma Recovery Scale change
Time Frame
through study completion, average 18 weeks
Title
Glasgow Coma Scale change
Time Frame
through study completion, average 18 weeks
Title
Levels of Cognitive Functioning change
Time Frame
through study completion, average 18 weeks
Title
Disability Rating Scale change
Time Frame
through study completion, average 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ospedale Generale di Zona "Moriggia Pelascini"
City
Gravedona ed Uniti
State/Province
CO
ZIP/Postal Code
22015
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
27447483
Citation
Frazzitta G, Zivi I, Valsecchi R, Bonini S, Maffia S, Molatore K, Sebastianelli L, Zarucchi A, Matteri D, Ercoli G, Maestri R, Saltuari L. Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: A Randomized Pilot Study in ICU. PLoS One. 2016 Jul 22;11(7):e0158030. doi: 10.1371/journal.pone.0158030. eCollection 2016.
Results Reference
derived

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Early Stepping Verticalization in ICU for ABI Patients

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