Trial Outcomes & Findings for Impact of the Erigo Machine on Functional Recovery in ICU Patients (NCT NCT02615990)
NCT ID: NCT02615990
Last Updated: 2018-05-25
Results Overview
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.
TERMINATED
NA
2 participants
Up to one year
2018-05-25
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
study terminated
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Erigo Pro Plus Standard Physical Therapy
n=1 Participants
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
|
Standard Physical Therapy
n=1 Participants
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.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: Up to one yearPopulation: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to one yearPopulation: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to three monthsPopulation: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one yearPopulation: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
The duration of hospitalization will be measured and compared between groups. Data will be presented as mean number of days the participant is hospitalized.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one yearPopulation: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one yearPopulation: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one yearPopulation: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
Incidence of DVT with be determined based on clinical symptoms to include pain and positive duplex ultrasound or other diagnostic tool
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one yearPopulation: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one yearPopulation: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one yearPopulation: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
Incidence of unplanned removal/displacement of lines/tubes/catheters. Data will be presented as the number of disruptions per participant per group.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At discharge (up to 1 year)Population: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one yearPopulation: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one yearPopulation: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one yearPopulation: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one yearPopulation: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one yearPopulation: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one yearPopulation: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
The number of participants discharged to their home will be counted and presented as a percentage of the total participants in that arm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one yearPopulation: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one yearPopulation: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one yearPopulation: ERIGO Pro manufacture requested the device be returned before any subject completed the protocol
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.
Outcome measures
Outcome data not reported
Adverse Events
Erigo Pro Plus Standard Physical Therapy
Standard Physical Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place