Baylor Institute for Rehabilitation
Dallas, Texas, 75246, United States
Location status: Recruiting
NCT Number: NCT07353892
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?
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Dallas, Texas, 75246, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
>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.
Overground robotic exoskeleton early ambulation (ORE-EA)
Usual care early ambulation (UC-EA) program for rehabilitation
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.
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
Time frame: From first ambulation session through study completion, expected to be less than 1 year
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
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
Role(s) of staff required to deliver early-ambulation sessions (i.e., set-up, intervention delivery, and take-down)
Contact information is provided by the study sponsor or research team.
Baylor Research Institute
Other
Robotic Exoskeletons in Acute Care Therapy - Cardiovascular and Thoracic Surgery
Acronym: REACT-CVTS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.