Skip to main content
OpenTrials
Completed

NCT Number: NCT02828371

Early Stepping Verticalization in ICU for ABI Patients

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Generale di Zona "Moriggia Pelascini"

Gravedona Ed Uniti, CO, 22015, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

conventional mobilization

Other

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

Primary outcomes

  1. Coma Recovery Scale change

    Time frame: through study completion, average 18 weeks

  2. Glasgow Coma Scale change

    Time frame: through study completion, average 18 weeks

  3. Levels of Cognitive Functioning change

    Time frame: through study completion, average 18 weeks

  4. Disability Rating Scale change

    Time frame: through study completion, average 18 weeks

Sponsors and collaborators

Lead sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

Other

Registry information

Official study title

Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: a Randomized Pilot Study in ICU

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 11, 2016
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.