Early Stepping Verticalization in ICU for ABI Patients

Not Applicable

Completed

• Conditions: Brain Injury; Consciousness Disorders
• Interventions: Other: conventional mobilization; Device: stepping verticalization

• Registration Number: NCT02828371
• Lead Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2016-07
• Study First Submitted: 2016-07-02
• Study First Submitted QC: 2016-07-06
• Last Update Submitted: 2016-07-06
• Study First Posted: 2016-07-11
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional	conventional mobilization	treated with conventional in-bed physiotherapy for 60 minutes a day, from Monday to Friday, throughout the ICU stay.
Erigo	stepping verticalization	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ospedale Generale di Zona "Moriggia Pelascini"; 🇮🇹 Gravedona ed Uniti, CO, Italy