Trauma Patients Requiring Physical RehabilitationMobilityNCT02615990
Impact of the Erigo Machine on Functional Recovery in ICU Patients
A study testing Erigo Pro and Standard Physical Therapy in people with Trauma Patients Requiring Physical Rehabilitation, run by Lisa J. Fryman at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Patients Requiring Physical Rehabilitation
- What is being tested?
- Erigo Pro and Standard Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with the following conditions:
- Non-weight bearing on lower extremities
- Untreated DVT
- Active hemorrhage
- Leg length >102cm or <72cm
- Weight >135kg
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Erigo Machine on Functional Recovery in ICU
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.
Read the 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.
- Being tested
- Erigo Pro, Standard Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erigo ProDevice
Also called Verticalization table, Item #29673 Hocoma products
Verticalization table with two integrated robotic devices for leg movement and cyclic loading
Standard Physical TherapyOther
Patients receive standard physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to one year
Secondary outcomes (18)
ICU Length of Stay
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.
Measured: Up to three months
Hospital Length of Stay
The duration of hospitalization will be measured and compared between groups. Data will be presented as mean number of days the participant is hospitalized.
Measured: Up to one year
Incidence of Pneumonia While Hospitalized
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.
Measured: Up to one year
Incidence of Urinary Tract Infections While Hospitalized
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.
Measured: Up to one year
Incidence of Deep Vein Thrombosis (DVT)
Incidence of DVT with be determined based on clinical symptoms to include pain and positive duplex ultrasound or other diagnostic tool
Measured: Up to one year
Incidence of Pressure Ulcers
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.
Measured: Up to one year
Incidence of Physical Instability
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.
Measured: Up to one year
Incidence of Catheter Disruption
Incidence of unplanned removal/displacement of lines/tubes/catheters. Data will be presented as the number of disruptions per participant per group.
Measured: Up to one year
Measure of Physical Capacity
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.
Measured: At discharge (up to 1 year)
Measure of Muscle Power
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.
Measured: Up to one year
Fall Risk
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.
Measured: Up to one year
Assessment of Participant Mobility
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.
Measured: Up to one year
Independent Ambulation
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.
Measured: Up to one year
Mid-leg Muscle Circumference
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.
Measured: Up to one year
Number of Patients Discharged From Hospital to Home
The number of participants discharged to their home will be counted and presented as a percentage of the total participants in that arm.
Measured: Up to one year
Number of Patients Discharged From Hospital to Skilled Nursing Facility
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.
Measured: Up to one year
Number of Patients Discharged From Hospital to a Long Term Care Facility
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.
Measured: Up to one year
Number of Patients Discharged From Hospital to an Acute Rehabilitation Facility
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.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startNov 2016
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Vendor equipment agreement expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Trauma Patients Requiring Physical RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisa J. Fryman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lisa J. Fryman, University of Kentucky
- Investigators
- Andrew Bernard, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615990
- Sponsor's protocol ID
- Erigo 15-0519
- Acronym
- Mobility
- Status last verified
- Apr 2018
- First submitted
- 5 Nov 2015
- Last updated
- 25 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This study did not gather data beyond one intervention before closing. This is not applicable.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Erigo Machine on Functional Recovery in ICU
- ClinicalTrials.gov ID
- NCT02615990
- Acronym / sponsor ID
- Mobility / Erigo 15-0519
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Vendor equipment agreement expired
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Lisa J. FrymanUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Posted 18 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erigo Pro plus standard Physical Therapy | Experimental | Device: Erigo ProThe 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. |
| Standard Physical Therapy | Active comparator | Other: Standard Physical TherapyPatients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Non-weight bearing on lower extremities
- Untreated DVT
- Active hemorrhage
- Leg length >102cm or <72cm
- Weight >135kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erigo ProAlso: Verticalization table, Item #29673 Hocoma productsVerticalization table with two integrated robotic devices for leg movement and cyclic loading | Device | Erigo Pro plus standard Physical Therapy |
| Standard Physical TherapyPatients receive standard physical therapy. | Other | Standard Physical Therapy |
Primary outcome
Orthostatic Tolerance During Verticalization
Time frame: 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
Time frame: 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.
18 secondary outcomes
ICU Length of Stay
Time frame: Up to three months
Hospital Length of Stay
Time frame: Up to one year
Incidence of Pneumonia While Hospitalized
Time frame: Up to one year
Incidence of Urinary Tract Infections While Hospitalized
Time frame: Up to one year
Incidence of Deep Vein Thrombosis (DVT)
Time frame: Up to one year
Incidence of Pressure Ulcers
Time frame: Up to one year
Incidence of Physical Instability
Time frame: Up to one year
Incidence of Catheter Disruption
Time frame: Up to one year
Measure of Physical Capacity
Time frame: At discharge (up to 1 year)
Measure of Muscle Power
Time frame: Up to one year
Fall Risk
Time frame: Up to one year
Assessment of Participant Mobility
Time frame: Up to one year
Independent Ambulation
Time frame: Up to one year
Mid-leg Muscle Circumference
Time frame: Up to one year
Number of Patients Discharged From Hospital to Home
Time frame: Up to one year
Number of Patients Discharged From Hospital to Skilled Nursing Facility
Time frame: Up to one year
Number of Patients Discharged From Hospital to a Long Term Care Facility
Time frame: Up to one year
Number of Patients Discharged From Hospital to an Acute Rehabilitation Facility
Time frame: Up to one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. This study did not gather data beyond one intervention before closing. This is not applicable.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Bernard, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erigo Pro and Standard Physical Therapy in people with Trauma Patients Requiring Physical Rehabilitation, run by Lisa J. Fryman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthostatic Tolerance During Verticalization (time frame: Up to one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2018.