Robot suit gets heart patients on their feet faster in ICU
NCT ID NCT07353892
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a robotic exoskeleton can help people who had heart or lung surgery walk sooner and more safely in the ICU. Twenty adults will be randomly assigned to either use the exoskeleton or receive standard physical therapy. Researchers will measure how quickly patients get upright, how much they walk, and whether the device is safe and practical.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Overground robotic exoskeleton early ambulation (ORE-EA)
- What this could lead to
- If it works, this could help heart surgery patients get out of bed and walk sooner, potentially speeding up recovery and reducing complications.
- What could go wrong
- This is a very small, early feasibility study with only 20 participants, so results may not apply to everyone. The exoskeleton might not be safe or practical for all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years 2. 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 \[transplant, durable or temporary ventricular assist device implantation (VAD), temporary mechanical circulatory support (tMCS), venovenous extracorporeal membrane oxygenation (VV ECMO)\]. 3. 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. 4. Requires ≥ 50% assist to perform upright activity based on physical therapy assessments (e.g., AMPAC-6 clicks or JH-HLM) 5. English or Spanish-speaking 6. Able to provide written informed consent (or via a legally authorized representative if applicable) 7. Meets ORE frame limitations (height = 5'2" to 6'4" and weight ≤ 220 lbs.) Exclusion Criteria: 1. Cognitive or behavioral impairment that interferes with safe participation \[e.g., active delirium (positive CAM-ICU score) or unable to follow commands\]. 2. 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. 3. Sustained ventricular arrhythmias that require intervention at the time of upright mobilization. 4. Any active dose of angiotensin II 5. Positive end-expiratory pressure (PEEP) ≥ 10 cm H20). 6. 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. 7. Skin disintegrity in proximity to the ORE frame 8. Participation in another interventional study that may confound outcome measures. 9. Pregnancy 10. 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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baylor Institute for Rehabilitation
RECRUITINGDallas, Texas, 75246, United States