Brain Injury Clinical Trial
Official title:
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).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care
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