Robotic Exoskeletons in Acute Care Therapy
ConditionPatients Post-cardiothoracic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaylor Research Institute
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Cognitive or behavioral impairment that interferes with safe participation [e.g., active delirium (positive CAM-ICU score) or unable to follow commands].
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Overground robotic exoskeleton early ambulation (ORE-EA)
DeviceOverground robotic exoskeleton early ambulation (ORE-EA)
Usual care early ambulation (UC-EA)
Other interventionUsual care early ambulation (UC-EA) program for rehabilitation
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Overground robotic exoskeleton early ambulation (ORE-EA)Experimental treatment 1 intervention
Group B: Usual care early ambulation (UC-EA)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time 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.2
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 yearSecondary outcomes
1
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 year2
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 year3
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 yearSponsors and contacts
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Source ClinicalTrials.gov