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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02828371
Other study ID # Erigo_eff
Secondary ID
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


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
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