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? * Are there differences in safety and feasibility?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
Overground robotic exoskeleton early ambulation (ORE-EA)
Usual care early ambulation (UC-EA) program for rehabilitation
Baylor Institute for Rehabilitation
Dallas, Texas, United States
RECRUITINGTime to ambulation
Time from admission in the ICU to the first upright ambulation session (in hours), assessed up to 12 months from admission.
Time frame: 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
Time frame: From first ambulation session through study completion, expected to be less than 1 year
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.
Time frame: 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)
Time frame: 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)
Time frame: From first ambulation session through study completion, expected to be less than 1 year
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