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NCT07353892 · Baylor Research Institute

Robotic Exoskeletons in Acute Care Therapy

(REACT-CVTS)

What this study is about

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.

View original scientific description

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.

Interventions

DEVICE

Overground robotic exoskeleton early ambulation (ORE-EA)

Overground robotic exoskeleton early ambulation (ORE-EA)

OTHER

Usual care early ambulation (UC-EA)

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

Primary outcome measures

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.

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

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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.
  • 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.

Where

  • Dallas, Texas

Related conditions & keywords

Patients Post-cardiothoracic Surgerycardiothoracic surgeryrehabilitationambulation

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jan 30, 2026 · Source of record for eligibility and locations

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1 of 20 participants interested
5% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

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Study locations

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RECRUITING

Dallas

Texas

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Patients Post-cardiothoracic Surgery Treatment in Dallas?

Join others in Texas exploring innovative treatment options through clinical research

Patients Post-cardiothoracic Surgery Treatment Options in Dallas, Texas

If you're searching for Patients Post-cardiothoracic Surgery treatment in Dallas, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Dallas and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Patients Post-cardiothoracic Surgery. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Texas
Now Enrolling
Up to 20 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Patients Post-cardiothoracic Surgery?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Patients Post-cardiothoracic Surgery

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Patients Post-cardiothoracic Surgery Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07353892. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.