Brain Injury, Consciousness Disorders
Conditions
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).
Interventions
DEVICEstepping 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
OTHERconventional mobilization
in-bed physiotherapy (mobilization exercises in supine and sitting position on bed, without out-of-bed mobilization nor verticalization)
Sponsors
Ospedale Generale Di Zona Moriggia-Pelascini
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Countries
Italy
Outcome results
None listed