Early Stepping Verticalization in ICU for ABI Patients

NCT ID: NCT02828371

Last Updated: 2016-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Erigo

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.

Group Type: EXPERIMENTAL

stepping verticalization

Intervention Type: 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

Conventional

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

Group Type: ACTIVE_COMPARATOR

conventional mobilization

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DEVICE

conventional mobilization

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale Generale Di Zona Moriggia-Pelascini

OTHER

Sponsor Role: lead

Responsible Party

Ilaria Zivi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ospedale Generale di Zona "Moriggia Pelascini"

Gravedona Ed Uniti, CO, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 27447483 (View on PubMed)

Other Identifiers

Erigo_eff

Identifier Type: -

Identifier Source: org_study_id