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NCT Number: NCT07353892

Robotic Exoskeletons in Acute Care Therapy

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?

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Institute for Rehabilitation

Dallas, Texas, 75246, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • English or Spanish-speaking
  • Able to provide written informed consent (or via a legally authorized representative if applicable)
  • Meets ORE frame limitations (height = 5'2" to 6'4" and weight ≤ 220 lbs.)

Exclusion criteria

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

  • 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).
  • 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.
  • Skin disintegrity in proximity to the ORE frame
  • Participation in another interventional study that may confound outcome measures.
  • Pregnancy
  • 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.

Treatment and study plan

Overground robotic exoskeleton early ambulation (ORE-EA)

Device

Overground robotic exoskeleton early ambulation (ORE-EA)

Usual care early ambulation (UC-EA)

Other

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

Primary outcomes

  1. Time to ambulation

    Time frame: From the date of ICU admission until the date of first documented upright ambulation session, up to 12 months.

    Time from admission in the ICU to the first upright ambulation session (in hours), assessed up to 12 months from admission.

  2. Ambulation dosage

    Time frame: From first ambulation session through study completion, expected to be less than 1 year

    Step count, total "up time" (minutes), and "walk time" (minutes) measured during each early-ambulation session

Secondary outcomes

  1. Adverse events of special interest

    Time frame: From first ambulation session through study completion, expected to be less than 1 year

    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.

  2. Feasibility of Overground Robotic Exoskeleton Early Ambulation (ORE-EA) -1

    Time frame: From first ambulation session through study completion, expected to be less than 1 year

    Number of staff required to deliver early-ambulation sessions (i.e., set-up, intervention delivery, and take-down)

  3. Feasibility of Overground Robotic Exoskeleton Early Ambulation (ORE-EA) -2

    Time frame: From first ambulation session through study completion, expected to be less than 1 year

    Role(s) of staff required to deliver early-ambulation sessions (i.e., set-up, intervention delivery, and take-down)

Study contacts

Contact information is provided by the study sponsor or research team.

Katelyn D Bosteder

CONTACT

[email protected]

214-820-6187

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

Robotic Exoskeletons in Acute Care Therapy - Cardiovascular and Thoracic Surgery

Acronym: REACT-CVTS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 21, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.