NCT07353892 · Baylor Research Institute
Robotic Exoskeletons in Acute Care Therapy
(REACT-CVTS)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Overground robotic exoskeleton early ambulation (ORE-EA)
Overground robotic exoskeleton early ambulation (ORE-EA)
OTHER
Usual care early ambulation (UC-EA)
Usual care early ambulation (UC-EA) program for rehabilitation
Primary outcome measures
Time to ambulation
Time frame: From the date of ICU admission until the date of first documented upright ambulation session, up to 12 months.
Time from admission in the ICU to the first upright ambulation session (in hours), assessed up to 12 months from admission.
Ambulation dosage
Time frame: From first ambulation session through study completion, expected to be less than 1 year
Step count, total "up time" (minutes), and "walk time" (minutes) measured during each early-ambulation session
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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 \[transplant, durable or temporary ventricular assist device implantation (VAD), temporary mechanical circulatory support (tMCS), venovenous extracorporeal membrane oxygenation (VV ECMO)\].
- 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.)
Exclusion criteria
- 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 dobutamine \>5.0 mcg/kg/min dopamine \>0.50 mcg/kg/min of milrinone Any combination of \> 3 of any of these, regardless of dose, unless deemed acceptable at the discretion of the treating attending.
- 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 considered if, in the judgment of the attending physician and physical therapy team, patient is appropriate for ambulation given patient's clinical status and IABP site and securement status, and if ambulation of appropriate patients with femoral IABP is consistent with local standard of care at the time of ambulation.
- Skin disintegrity in proximity to the ORE frame
- Participation in another interventional study that may confound outcome measures.
- 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.
Where
- Dallas, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 30, 2026 · Source of record for eligibility and locations