Impact of the Erigo Machine on Functional Recovery in ICU Patients

Study Overview
=================
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.

Official Title
-----------------
Impact of the Erigo Machine on Functional Recovery in ICU

Conditions
-----------------
Trauma Patients Requiring Physical Rehabilitation

Intervention / Treatment
-----------------
* Device: Erigo Pro
* Other: Standard Physical Therapy


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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erigo Pro plus standard Physical Therapy<br>The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. | Device: Erigo Pro<br>* Verticalization table with two integrated robotic devices for leg movement and cyclic loading<br>* Other names: Item #29673 Hocoma products;|
| Active Comparator: Standard Physical Therapy<br>Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. | Other: Standard Physical Therapy<br>* Patients receive standard physical therapy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orthostatic Tolerance During Verticalization | Rapid decreases in blood pressure are a common clinical challenge when trauma patients go from lying down to standing. Changes in blood pressure will be compared between groups to determine if verticalization with an ERIGO Pro tilt table will alleviate the drop in blood pressure more quickly than standard of care. Participants will have their blood pressure measured upon initial verticalization after injury and at each treatment session there after until they achieve ambulation (the ability to move without assistance). Data will be presented as the number of days of treatment required to achieve blood pressure homeostasis during the positional change from lying to standing. | Up to one year | 
| Orthostatic Tolerance During Ambulation | Rapid decreases in blood pressure are a common clinical challenge when trauma patients go from standing to full ambulation. Changes in blood pressure will be compared between groups to determine if verticalization with an ERIGO Pro tilt table will alleviate the drop in blood pressure more quickly than standard of care. Participants will have their blood pressure measured upon initial unassisted standing and then during each treatment session there after until discharge. Data will be presented as the number of days of treatment required to achieve blood pressure homeostasis during the positional change from standing to full ambulation. | Up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Length of Stay | The duration of stay in the Trauma ICU will be measured and compared between groups. Data will be presented as mean number of days in the ICU. | Up to three months | 
| Hospital Length of Stay | The duration of hospitalization will be measured and compared between groups. Data will be presented as mean number of days the participant is hospitalized. | Up to one year | 
| Incidence of Pneumonia While Hospitalized | Incidence of pneumonia while hospitalized will be determined by clinical symptoms to include temperature >100.8 degrees F, WBC>12,000 WBC/mm3 , PaO2/Fio2 ratio < 300 mmHg, positive respiratory culture for organisms and chest x-ray indicative of pneumonia. Total incidence will be compared between groups and presented as a total count of pneumonia diagnoses per group. | Up to one year | 
| Incidence of Urinary Tract Infections While Hospitalized | Incidence of urinary tract infection during hospitalization will be determined by clinical symptoms to include temperature of > 100.8 degrees F, WBC> 12000 WBC/MM3, patient complaints of pain, positive urine culture. Total incidence will be compared between groups and presented as a total count of urinary tract infection diagnoses per group. | Up to one year | 
| Incidence of Deep Vein Thrombosis (DVT) | Incidence of DVT with be determined based on clinical symptoms to include pain and positive duplex ultrasound or other diagnostic tool | Up to one year | 
| Incidence of Pressure Ulcers | Incidence of pressure ulcers determined by physical observation. Total incidence will be compared between groups and presented as a total count of pressure ulcer diagnoses per group. | Up to one year | 
| Incidence of Physical Instability | Incidence of physical instability with be calculated as the number of falls per participant while hospitalized. Data will be presented as the number of falls per participant per group. | Up to one year | 
| Incidence of Catheter Disruption | Incidence of unplanned removal/displacement of lines/tubes/catheters. Data will be presented as the number of disruptions per participant per group. | Up to one year | 
| Measure of Physical Capacity | Kansas University Hospital Physical Therapy Acute Care Functional Outcome Tool will be utilized to assess the participant's overall physical function prior to discharge. . Total score: 0 - 32, usually divided by 25%, 50%, >75% (minimum, moderate, maximum functionality). The higher the score, the great physical function the participant has. | At discharge (up to 1 year) | 
| Measure of Muscle Power | The Muscle Research Council Muscle Scale will be used to determine actual muscle power generation vs the anticipated power generation prior to discharge. Total score: 0 - 5, 5 is normal muscle function. Data are presented as units on a scale. | Up to one year | 
| Fall Risk | Participant fall risk will be determined prior to discharge using the Berg Balance Scale to assess impairment of balance function through the completion of several functional tasks. The data are presented as units on a scale. The higher the number the lower the fall risk. | Up to one year | 
| Assessment of Participant Mobility | The ICU Mobility Scale ranks a participant's mobility on a scale of 0-32, were a score of zero is a completely non-mobile individual and a score of 32 is a fully ambulatory individual. Data will be collected at the time of discharge. The data are presented as units on a scale. | Up to one year | 
| Independent Ambulation | The number of hospital days required for the participant to regain independent ambulation (the ability to walk 5 meters unassisted) with be measured and presented as total days. | Up to one year | 
| Mid-leg Muscle Circumference | Mid-leg muscle circumference will be measure using a metric tape measure at hospital admission and again just prior to discharge. Data will be presented as the change in muscle circumference (cm) over time. | Up to one year | 
| Number of Patients Discharged From Hospital to Home | The number of participants discharged to their home will be counted and presented as a percentage of the total participants in that arm. | Up to one year | 
| Number of Patients Discharged From Hospital to Skilled Nursing Facility | The number of participants discharged to a skilled nursing home will be counted and presented as a percentage of the total participants in that arm. | Up to one year | 
| Number of Patients Discharged From Hospital to a Long Term Care Facility | The number of participants discharged to a long term care facility will be counted and presented as a percentage of the total participants in that arm. | Up to one year | 
| Number of Patients Discharged From Hospital to an Acute Rehabilitation Facility | The number of participants discharged to am acute rehabilitation facility will be counted and presented as a percentage of the total participants in that arm. | Up to one year |