Robotic Exoskeletons in Acute Care Therapy (REACT-CVTS)

Robotic Exoskeletons in Acute Care Therapy - Cardiovascular and Thoracic Surgery

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 Overview

• Status: Recruiting
• Conditions: Patients Post-cardiothoracic Surgery
• Intervention / Treatment: Device: Overground robotic exoskeleton early ambulation (ORE-EA); Other: Usual care early ambulation (UC-EA)

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katelyn D Bosteder; Phone Number: 214-820-6187; Email: Katelyn.Bosteder@BSWHealth.org

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor Institute for Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. 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)].
3. 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.
4. Requires ≥ 50% assist to perform upright activity based on physical therapy assessments (e.g., AMPAC-6 clicks or JH-HLM)
5. English or Spanish-speaking
6. Able to provide written informed consent (or via a legally authorized representative if applicable)
7. Meets ORE frame limitations (height = 5'2" to 6'4" and weight ≤ 220 lbs.)

Exclusion Criteria:

1. Cognitive or behavioral impairment that interferes with safe participation [e.g., active delirium (positive CAM-ICU score) or unable to follow commands].

2. Moderate vasopressor or inotrope requirements, including:

   >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.

3. Sustained ventricular arrhythmias that require intervention at the time of upright mobilization.
4. Any active dose of angiotensin II
5. Positive end-expiratory pressure (PEEP) ≥ 10 cm H20).
6. Except for those with a femoral arterial balloon pump, all patients with existing femoral arterial lines at the time of ambulation are ineligible. However, patients with femoral intraortic balloon pump (IABP) may be considered if, in the judgment of the attending physician and physical therapy team, patient is appropriate for ambulation given patient's clinical status and IABP site and securement status, and if ambulation of appropriate patients with femoral IABP is consistent with local standard of care at the time of ambulation.
7. Skin disintegrity in proximity to the ORE frame
8. Participation in another interventional study that may confound outcome measures.
9. Pregnancy
10. Any other condition that, in the judgment of the clinical or research team, would pose an unacceptable risk or interfere with study participation or interpretation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Overground robotic exoskeleton early ambulation (ORE-EA)	Device: Overground robotic exoskeleton early ambulation (ORE-EA); Overground robotic exoskeleton early ambulation (ORE-EA)
Active Comparator: Usual care early ambulation (UC-EA); Standard of care	Other: Usual care early ambulation (UC-EA); Usual care early ambulation (UC-EA) program for rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to ambulation	Time from admission in the ICU to the first upright ambulation session (in hours), assessed up to 12 months from admission.	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	From first ambulation session through study completion, expected to be less than 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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)	From first ambulation session through study completion, expected to be less than 1 year

Collaborators and Investigators

• Sponsor: Baylor Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: rehabilitation; cardiothoracic surgery; ambulation
• Other Study ID Numbers: 025-408

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There currently is no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes