Impact of the Erigo Machine on Functional Recovery in ICU Patients

NCT02615990 | Terminated Results FDA Device

• 1 other identifier: Erigo 15-0519
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma Patients Requiring Physical Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• ICU Length of Stay

  Up to three months

• Hospital Length of Stay

  Up to one year

• Incidence of Pneumonia While Hospitalized

  Up to one year

• Incidence of Urinary Tract Infections While Hospitalized

  Up to one year

• Incidence of Deep Vein Thrombosis (DVT)

  Up to one year

Study Arms (2)

Erigo Pro plus standard Physical Therapy

EXPERIMENTAL

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

Standard Physical Therapy

ACTIVE COMPARATOR

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

Interventions

Erigo Pro DEVICE

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

Also known as: Verticalization table, Item #29673 Hocoma products

Erigo Pro plus standard Physical Therapy

Standard Physical Therapy OTHER

Patients receive standard physical therapy.

Standard Physical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lisa J. Fryman: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Limitations and Caveats

Study was terminated by the device manufacturer prior to any subject completing the intervention

Results Point of Contact

• Title: Lisa Fryman
• Organization: University of Kentucky

lisa.fryman@uky.edu

859 323 2060

Study Officials

• Andrew Bernard, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nursing Director Trauma/Surgical Services

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 26, 2015
• Study Start: November 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 25, 2018
• Results First Posted: May 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)