Impact of the Erigo Machine on Functional Recovery in ICU Patients

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2016-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Trauma Patients Requiring Physical Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Erigo Pro

Intervention Type DEVICE

Verticalization table with two integrated robotic devices for leg movement and cyclic loading

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.

Group Type ACTIVE_COMPARATOR

Standard Physical Therapy

Intervention Type OTHER

Patients receive standard physical therapy.

Interventions

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Erigo Pro

Verticalization table with two integrated robotic devices for leg movement and cyclic loading

Intervention Type DEVICE

Standard Physical Therapy

Patients receive standard physical therapy.

Intervention Type OTHER

Other Intervention Names

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Verticalization table Item #29673 Hocoma products

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No