Impact of the Erigo Machine on Functional Recovery in ICU Patients

Impact of the Erigo Machine on Functional Recovery in ICU

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02615990

Acronym

Mobility

Enrollment

Registered

2015-11-26

Start date

2016-11-30

Completion date

2016-11-30

Last updated

2018-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma Patients Requiring Physical Rehabilitation

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.

Interventions

DEVICEErigo Pro

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

OTHERStandard Physical Therapy

Patients receive standard physical therapy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Orthostatic Tolerance During Verticalization	Up to one year	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.
Orthostatic Tolerance During Ambulation	Up to one year	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.

Secondary

Measure	Time frame	Description
Incidence of Pneumonia While Hospitalized	Up to one year	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.
Incidence of Urinary Tract Infections While Hospitalized	Up to one year	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.
Incidence of Deep Vein Thrombosis (DVT)	Up to one year	Incidence of DVT with be determined based on clinical symptoms to include pain and positive duplex ultrasound or other diagnostic tool
Incidence of Pressure Ulcers	Up to one year	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.
Incidence of Physical Instability	Up to one year	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.
Incidence of Catheter Disruption	Up to one year	Incidence of unplanned removal/displacement of lines/tubes/catheters. Data will be presented as the number of disruptions per participant per group.
Measure of Physical Capacity	At discharge (up to 1 year)	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.
Measure of Muscle Power	Up to one year	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.
ICU Length of Stay	Up to three months	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.
Assessment of Participant Mobility	Up to one year	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.
Independent Ambulation	Up to one year	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.
Mid-leg Muscle Circumference	Up to one year	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.
Number of Patients Discharged From Hospital to Home	Up to one year	The number of participants discharged to their home will be counted and presented as a percentage of the total participants in that arm.
Number of Patients Discharged From Hospital to Skilled Nursing Facility	Up to one year	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.
Number of Patients Discharged From Hospital to a Long Term Care Facility	Up to one year	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.
Number of Patients Discharged From Hospital to an Acute Rehabilitation Facility	Up to one year	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.
Fall Risk	Up to one year	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.
Hospital Length of Stay	Up to one year	The duration of hospitalization will be measured and compared between groups. Data will be presented as mean number of days the participant is hospitalized.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	1
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. Standard Physical Therapy: Patients receive standard physical therapy.	1
Total	2

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	study terminated	1	1

Baseline characteristics

Characteristic	Standard Physical Therapy	Total	Erigo Pro Plus Standard Physical Therapy
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	1 Participants	2 Participants	1 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment United States	1 Participants	2 Participants	1 Participants
Sex: Female, Male Female	0 Participants	1 Participants	1 Participants
Sex: Female, Male Male	1 Participants	1 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 1	0 / 0
other Total, other adverse events	0 / 1	0 / 0
serious Total, serious adverse events	0 / 1	0 / 0

Outcome results

Primary

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.

Time frame: Up to one year