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

Lisa J. Fryman

Status: Terminated

Conditions: Trauma Patients Requiring Physical Rehabilitation

Treatments: Device: Erigo Pro; Other: Standard Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02615990

Erigo 15-0519

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Erigo Pro plus standard Physical Therapy

Experimental group

Description:

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.

Treatment:

Device: Erigo Pro

Standard Physical Therapy

Active Comparator group

Description:

Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.

Treatment:

Other: Standard Physical Therapy