Patients Post-cardiothoracic SurgeryREACT-CVTSNCT07353892
Robotic Exoskeletons in Acute Care Therapy
A study testing Overground robotic exoskeleton early ambulation (ORE-EA) in people with Patients Post-cardiothoracic Surgery, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Post-cardiothoracic Surgery
- What is being tested?
- Overground robotic exoskeleton early ambulation (ORE-EA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor Institute for Rehabilitation
Dallas, Texas, 75246
About this study
Official title: 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?
- Conditions
- Patients Post-cardiothoracic Surgery
- Being tested
- Overground robotic exoskeleton early ambulation (ORE-EA), Usual care early ambulation (UC-EA)
- Keywords
- cardiothoracic surgery, rehabilitation, ambulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Overground robotic exoskeleton early ambulation (ORE-EA) | Experimental | Overground robotic exoskeleton early ambulation (ORE-EA) Receives: Device: Overground robotic exoskeleton early ambulation (ORE-EA) |
| Usual care early ambulation (UC-EA) | Active comparator | Standard of care Receives: Other: Usual care early ambulation (UC-EA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to ambulation
Time from admission in the ICU to the first upright ambulation session (in hours), assessed up to 12 months from admission.
Measured: 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
Measured: From first ambulation session through study completion, expected to be less than 1 year
Secondary outcomes (3)
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.
Measured: 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)
Measured: 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)
Measured: From first ambulation session through study completion, expected to be less than 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start2 Dec 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Post-cardiothoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to experimental treatment vs. Standard -of care treatment in 2:1 ratio
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353892
- Sponsor's protocol ID
- 025-408
- Acronym
- REACT-CVTS
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There currently is no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Exoskeletons in Acute Care Therapy - Cardiovascular and Thoracic Surgery
- ClinicalTrials.gov ID
- NCT07353892
- Acronym / sponsor ID
- REACT-CVTS / 025-408
- Conditions
- Patients Post-cardiothoracic Surgery
- Keywords
- cardiothoracic surgery, rehabilitation, ambulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomized to experimental treatment vs. Standard -of care treatment in 2:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Overground robotic exoskeleton early ambulation (ORE-EA) | Experimental | Device: Overground robotic exoskeleton early ambulation (ORE-EA)Overground robotic exoskeleton early ambulation (ORE-EA) |
| Usual care early ambulation (UC-EA) | Active comparator | Other: Usual care early ambulation (UC-EA)Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Overground robotic exoskeleton early ambulation (ORE-EA)Overground robotic exoskeleton early ambulation (ORE-EA) | Device | Overground robotic exoskeleton early ambulation (ORE-EA) |
| Usual care early ambulation (UC-EA)Usual care early ambulation (UC-EA) program for rehabilitation | Other | Usual care early ambulation (UC-EA) |
Primary outcome
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
3 secondary outcomes
Adverse events of special interest
Time frame: From first ambulation session through study completion, expected to be less than 1 year
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No. There currently is no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overground robotic exoskeleton early ambulation (ORE-EA) in people with Patients Post-cardiothoracic Surgery, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katelyn D Bosteder (214-820-6187, Katelyn.Bosteder@BSWHealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.