Impact of the Erigo Machine on Functional Recovery in ICU Patients (Mobility)

Impact of the Erigo Machine on Functional Recovery in ICU

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 Overview

• Status: Terminated
• Conditions: Trauma Patients Requiring Physical Rehabilitation
• Intervention / Treatment: Device: Erigo Pro; Other: Standard Physical Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erigo Pro plus standard Physical Therapy; 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; Verticalization table with two integrated robotic devices for leg movement and cyclic loading; Other Names: Verticalization table; Item #29673 Hocoma products
Active Comparator: Standard Physical Therapy; 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; Patients receive standard physical therapy.

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

Collaborators and Investigators

• Sponsor: Lisa J. Fryman
• Investigators: Principal Investigator: Andrew Bernard, MD, University of Kentucky

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: November 5, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (Estimate): November 26, 2015

Study Record Updates

• Last Update Posted (Actual): May 25, 2018
• Last Update Submitted That Met QC Criteria: May 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Erigo 15-0519

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study did not gather data beyond one intervention before closing. This is not applicable.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No