Expired Study
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Lexington, Kentucky 40536


Purpose:

This study will assess the effects of the Erigo applied as part of the early mobilization program in the Trauma ICU at the University of Kentucky. It is our hypothesis, that with the Erigo, critically ill patients will tolerate verticalization and mobilization earlier and safely resulting in improved outcomes measured by increased mobility and strength on ICU discharge, decreased requirements for mechanical ventilation, reduced complication rates and decreased ICU and hospital LOS.


Study summary:

The "Erigo" by Hocoma is a combination of tilt table with a robotic stepper device allowing for cyclic leg loading. Erigo now also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It allows for protected gradual verticalization and mobilization based on patient tolerance and progress. It has been shown to improve orthostatic tolerance, cerebral blood flow and muscle strength. Prospective Randomized Controlled Trial will compare two groups. The patients that meet inclusion criteria will be randomized into either the treatment group or a control group. General ICU mobility guidelines consist of scaled activity related to the patients' stability. The control group will get the general ICU mobility treatments and the treatment group will have one mobility treatment replaced with the Erigo treatment.


Criteria:

Inclusion Criteria: Admission to Trauma ICU 1. Trauma Patients requiring physical therapy (including severe traumatic brain injury or polytrauma without extremity fractures or unstable thoracic or lumbar spine fracture 2. Burn patients requiring physical therapy 3. GI surgery patients requiring physical therapy 4. Necrotizing fasciitis patient requiring physical therapy Exclusion Criteria: Patients with the following conditions: 1. Non-weight bearing on lower extremities 2. Untreated DVT 3. Active hemorrhage 4. Leg length >102cm or <72cm 5. Weight >135kg 6. Systolic BP > 20mmHg sustained for 10min 7. Heart rate >20bpm outside goal for more than 20min 8. Intracranial pressure (ICP) >20mmHg sustained for 10min if applicable, 9. Temperature >38.2C


NCT ID:

NCT02615990


Primary Contact:

Principal Investigator
Andrew Bernard, MD
University of Kentucky


Backup Contact:

N/A


Location Contact:

Lexington, Kentucky 40536
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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