A pilot randomized controlled trial protocol of overground robotic exoskeleton-assisted early ambulation after...

Early ambulation following cardiovascular and thoracic surgery (CVTS) is associated with improved postoperative outcomes. However, barriers such as patient debility, high acuity, hemodynamic instability, cardiopulmonary complications, or resource limitations (e.g., intensive care unit setting, specialized equipment, or staff training) often prevent or delay early ambulation. Overground robotic exoskeletons (ORE) may facilitate earlier and higher-dose ambulation, yet their role in acute CVTS recovery remains uninvestigated. To evaluate the safety, feasibility, and preliminary outcomes of ORE-assisted early ambulation in postoperative CVTS patients in the intensive care unit setting, we will conduct a single-center pilot randomized controlled trial. Twenty participants will be randomized 2:1 to receive either ORE plus usual care or usual care alone. Primary outcomes include time from intensive care unit admission to first upright ambulation (hours) and ambulation dosage (upright time, walking time, and steps). Secondary outcomes assess safety (adverse events) and feasibility (staffing requirements). This randomized controlled trial is the first investigation of ORE for early ambulation in the CVTS population and will lay the groundwork for the integration of advanced ORE technology into cardiopulmonary rehabilitation.