Early Stepping Verticalization in ICU for ABI Patients

Study Overview
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Brief Summary
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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).

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

Conditions
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Brain Injury, Consciousness Disorders

Intervention / Treatment
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* Device: stepping verticalization
* Other: conventional mobilization


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erigo<br>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<br>* 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<br>|
| Active Comparator: Conventional<br>treated with conventional in-bed physiotherapy for 60 minutes a day, from Monday to Friday, throughout the ICU stay. | Other: conventional mobilization<br>* in-bed physiotherapy (mobilization exercises in supine and sitting position on bed, without out-of-bed mobilization nor verticalization)<br>|

What is the study measuring?
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Primary Outcome Measures

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