Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: a Randomized Pilot Study in ICU
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Brain Injury
- Sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Coma Recovery Scale change
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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).
Investigators
Ilaria Zivi
MD
Ospedale Generale Di Zona Moriggia-Pelascini
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.
Outcomes
Primary Outcomes
Coma Recovery Scale change
Time Frame: through study completion, average 18 weeks
Glasgow Coma Scale change
Time Frame: through study completion, average 18 weeks
Levels of Cognitive Functioning change
Time Frame: through study completion, average 18 weeks
Disability Rating Scale change
Time Frame: through study completion, average 18 weeks