Early Stepping Verticalization in ICU for ABI Patients

NCT02828371 | Completed

• 1 other identifier: Erigo_eff
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Brain Injury; Consciousness Disorders

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Erigo

EXPERIMENTAL

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

Conventional

ACTIVE COMPARATOR

treated with conventional in-bed physiotherapy for 60 minutes a day, from Monday to Friday, throughout the ICU stay.

Other: conventional mobilization

Interventions

stepping verticalization DEVICE

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

Erigo

conventional mobilization OTHER

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

Conventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ospedale Generale Di Zona Moriggia-Pelascini: lead

Study Sites (1)

Ospedale Generale di Zona "Moriggia Pelascini"

Gravedona Ed Uniti, CO, 22015, Italy

Location

Related Publications (1)

• Frazzitta G, Zivi I, Valsecchi R, Bonini S, Maffia S, Molatore K, Sebastianelli L, Zarucchi A, Matteri D, Ercoli G, Maestri R, Saltuari L. Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: A Randomized Pilot Study in ICU. PLoS One. 2016 Jul 22;11(7):e0158030. doi: 10.1371/journal.pone.0158030. eCollection 2016.

  PMID: 27447483 DERIVED

MeSH Terms

Conditions

Brain Injuries; Consciousness Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 2, 2016
• First Posted: July 11, 2016
• Study Start: January 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 11, 2016

Record last verified: 2016-07

Locations

IT (1)