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
Qualifiers
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
Treatments tested in this trial
- Overground robotic exoskeleton early ambulation (ORE-EA)
- Usual care early ambulation (UC-EA)
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov