Recruiting

ORE-EA vs. UC-EA

Sponsor:

Baylor Research Institute

Code:

NCT07353892

Conditions

Patients Post-cardiothoracic Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Overground robotic exoskeleton early ambulation (ORE-EA)

Usual care early ambulation (UC-EA)

Study Details

Brief summary:

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?

Conditions

Patients Post-cardiothoracic Surgery

Study ID

NCT07353892

Start date

Dec 2, 2025

Status verified date

Jan, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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

Interventions

Overground robotic exoskeleton early ambulation (ORE-EA)

Overground robotic exoskeleton early ambulation (ORE-EA)

Usual care early ambulation (UC-EA)

Usual care early ambulation (UC-EA) program for rehabilitation

Primary outcome measure

  • Time to ambulation [ Time Frame: From the date of ICU admission until the date of first documented upright ambulation session, up to 12 months. ]
  • Ambulation dosage [ Time Frame: From first ambulation session through study completion, expected to be less than 1 year ]

Central Contacts and Locations

Central contacts

Locations

Baylor Institute for Rehabilitation

Recruiting

Dallas, Texas, United States, 75246

More Information

Sponsor

Baylor Research Institute

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

  • cardiothoracic surgery
  • rehabilitation
  • ambulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor Research Institute on 2026-01-30.