Early Stepping Verticalization in ICU for ABI Patients

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828371
• Other study ID #: Erigo_eff
• Status: Completed
• Phase: N/A
• First received: July 2, 2016
• Last updated: July 6, 2016
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: Ospedale Generale Di Zona Moriggia-Pelascini
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Consciousness Disorders

Intervention

Device:
• stepping 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

Other:
• conventional mobilization
in-bed physiotherapy (mobilization exercises in supine and sitting position on bed, without out-of-bed mobilization nor verticalization)

Locations

Country	Name	City	State
Italy	Ospedale Generale di Zona "Moriggia Pelascini"	Gravedona ed Uniti	CO

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Generale Di Zona Moriggia-Pelascini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coma Recovery Scale change		through study completion, average 18 weeks	No
Primary	Glasgow Coma Scale change		through study completion, average 18 weeks	No
Primary	Levels of Cognitive Functioning change		through study completion, average 18 weeks	No
Primary	Disability Rating Scale change		through study completion, average 18 weeks	No