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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overground robotic exoskeleton early ambulation (ORE-EA) | Experimental | Overground robotic exoskeleton early ambulation (ORE-EA) |
|
| Usual care early ambulation (UC-EA) | Active Comparator | Standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Overground robotic exoskeleton early ambulation (ORE-EA) | Device | Overground robotic exoskeleton early ambulation (ORE-EA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to ambulation | Time from admission in the ICU to the first upright ambulation session (in hours), assessed up to 12 months from admission. | From the date of ICU admission until the date of first documented upright ambulation session, up to 12 months. |
| Ambulation dosage | Step count, total "up time" (minutes), and "walk time" (minutes) measured during each early-ambulation session | From first ambulation session through study completion, expected to be less than 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events of special interest | Predefined events considered of particular concern to study safety and tolerability, specifically: discontinuation of a therapy session due to acute medical deterioration (e.g., hypotension, arrhythmia, respiratory distress), pain limiting progression, new requirement for escalation of vasopressor/inotropic support during or immediately after ambulation, unanticipated device-related complication directly linked to the Overground Robotic Exoskeleton or ambulation activity. |
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Inclusion Criteria:
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.
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katelyn D Bosteder | Contact | 214-820-6187 | Katelyn.Bosteder@BSWHealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Institute for Rehabilitation | Recruiting | Dallas | Texas | 75246 | United States |
There currently is no plan to share IPD
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Subjects will be randomized to experimental treatment vs. Standard -of care treatment in 2:1 ratio
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| Usual care early ambulation (UC-EA) | Other | Usual care early ambulation (UC-EA) program for rehabilitation |
|
| From first ambulation session through study completion, expected to be less than 1 year |
| Feasibility of Overground Robotic Exoskeleton Early Ambulation (ORE-EA) -1 | Number of staff required to deliver early-ambulation sessions (i.e., set-up, intervention delivery, and take-down) | From first ambulation session through study completion, expected to be less than 1 year |
| Feasibility of Overground Robotic Exoskeleton Early Ambulation (ORE-EA) -2 | Role(s) of staff required to deliver early-ambulation sessions (i.e., set-up, intervention delivery, and take-down) | From first ambulation session through study completion, expected to be less than 1 year |