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New treatment option for Patients Post-cardiothoracic Surgery
Official title Robotic Exoskeletons in Acute Care Therapy
ClinicalTrials.gov ID: NCT07353892
What this study is testing
- What it's testing
- The goal of this clinical trial is to establish the safety, feasibility, and preliminary findings of overground robotic exoskeleton early ambulation (ORE-EA) compared to usual care early ambulation (UC-EA) in the rehabilitation of patients who have had cardiovascular or thoracic surgery. The main questions it aims to answer are: Is there a difference between groups in time between surgery and ambulation?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Underwent cardiovascular or thoracic surgery, including but not limited to coronary artery bypass grafting, valve replacement/repair, lung resection...
- Medically appropriate for physical therapy, including upright activity and ambulation, as defined by an order in the patient's electronic medical...
- Requires ≥ 50% assist to perform upright activity based on physical therapy assessments (e.g., AMPAC-6 clicks or JH-HLM)
- English or Spanish-speaking
You likely can't join if
- Cognitive or behavioral impairment that interferes with safe participation [e.g., active delirium (positive CAM-ICU score) or unable to follow...
- Moderate vasopressor or inotrope requirements, including: \>0.10 mcg/kg/min of norepinephrine \>0.03 mcg/kg/min of epinephrine \>80.0 mcg/kg/min of...
- Sustained ventricular arrhythmias that require intervention at the time of upright mobilization.
- Any active dose of angiotensin II
- Positive end-expiratory pressure (PEEP) ≥ 10 cm H20).
- Except for those with a femoral arterial balloon pump, all patients with existing femoral arterial lines at the time of ambulation are ineligible...
See the full eligibility criteria
- Age ≥ 18 years
- Underwent cardiovascular or thoracic surgery, including but not limited to coronary artery bypass grafting, valve replacement/repair, lung resection, or advanced cardiovascular or pulmonary therapies [transplant...
- Medically appropriate for physical therapy, including upright activity and ambulation, as defined by an order in the patient's electronic medical record signed by a physician or advanced practice provider.
- Requires ≥ 50% assist to perform upright activity based on physical therapy assessments (e.g., AMPAC-6 clicks or JH-HLM)
- English or Spanish-speaking
- Able to provide written informed consent (or via a legally authorized representative if applicable)
- Meets ORE frame limitations (height = 5'2" to 6'4" and weight ≤ 220 lbs.)
- Cognitive or behavioral impairment that interferes with safe participation [e.g., active delirium (positive CAM-ICU score) or unable to follow commands].
- Moderate vasopressor or inotrope requirements, including: \>0.10 mcg/kg/min of norepinephrine \>0.03 mcg/kg/min of epinephrine \>80.0 mcg/kg/min of phenylephrine \>0.04 units/min of vasopressin \>5.0 mcg/kg/min of...
- Sustained ventricular arrhythmias that require intervention at the time of upright mobilization.
- Any active dose of angiotensin II
- Positive end-expiratory pressure (PEEP) ≥ 10 cm H20).
- Except for those with a femoral arterial balloon pump, all patients with existing femoral arterial lines at the time of ambulation are ineligible. However, patients with femoral intraortic balloon pump (IABP) may be...
- Skin disintegrity in proximity to the ORE frame
- Participation in another treatment study that may confound outcome measures.
- Pregnancy
- Any other condition that, in the judgment of the clinical or research team, would pose an unacceptable risk or interfere with study participation or interpretation.
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.