Clinical trial NCT02615990: Impact of the Erigo Machine on Functional Recovery in ICU Patients
Official title: Impact of the Erigo Machine on Functional Recovery in ICU
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Trauma Patients Requiring Physical Rehabilitation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2015-11-26
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Orthostatic Tolerance During Verticalization
timeFrame: Up to one year
measure: Orthostatic Tolerance During Ambulation
timeFrame: Up to one year
Secondary outcomes:
measure: ICU Length of Stay
timeFrame: Up to three months
measure: Hospital Length of Stay
timeFrame: Up to one year
measure: Incidence of Pneumonia While Hospitalized
timeFrame: Up to one year
measure: Incidence of Urinary Tract Infections While Hospitalized
timeFrame: Up to one year
measure: Incidence of Deep Vein Thrombosis (DVT)
timeFrame: Up to one year
measure: Incidence of Pressure Ulcers
timeFrame: Up to one year
measure: Incidence of Physical Instability
timeFrame: Up to one year
measure: Incidence of Catheter Disruption
timeFrame: Up to one year
measure: Measure of Physical Capacity
timeFrame: At discharge (up to 1 year)
measure: Measure of Muscle Power
timeFrame: Up to one year
measure: Fall Risk
timeFrame: Up to one year
measure: Assessment of Participant Mobility
timeFrame: Up to one year
measure: Independent Ambulation
timeFrame: Up to one year
measure: Mid-leg Muscle Circumference
timeFrame: Up to one year
measure: Number of Patients Discharged From Hospital to Home
timeFrame: Up to one year
measure: Number of Patients Discharged From Hospital to Skilled Nursing Facility
timeFrame: Up to one year
measure: Number of Patients Discharged From Hospital to a Long Term Care Facility
timeFrame: Up to one year
measure: Number of Patients Discharged From Hospital to an Acute Rehabilitation Facility
timeFrame: Up to one year
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Andrew Bernard, MD
role: PRINCIPAL_INVESTIGATOR
References: