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20 Participants Needed

Robotic Exoskeletons for Post-Surgery Recovery

(REACT-CVTS Trial)

KD
Overseen ByKatelyn D Bosteder
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Baylor Research Institute
Must not be taking: Vasopressors, Inotropes, Angiotensin II
Disqualifiers: Cognitive impairment, Ventricular arrhythmias, Pregnancy, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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?

Are You a Good Fit for This Trial?

Adults over 18 who've had heart or lung surgery and need help to stand or walk can join this trial. They must speak English or Spanish, consent to participate, fit the exoskeleton's size limits (5'2" to 6'4", max weight of 220 lbs), and be cleared for physical therapy.

Inclusion Criteria

I can sign the consent form myself or have someone legally authorized to do it for me.
Meets ORE frame limitations (height = 5'2" to 6'4" and weight ≤ 220 lbs.)
I am 18 years old or older.
See 4 more

Exclusion Criteria

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
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo early ambulation using either overground robotic exoskeleton or usual care after cardiovascular or thoracic surgery

Up to 12 months
Regular sessions as per rehabilitation protocol

Follow-up

Participants are monitored for safety, feasibility, and ambulation outcomes after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Overground Robotic Exoskeleton Early Ambulation (ORE-EA)

Trial Overview

The study compares two ways of helping patients walk after surgery: usual care with standard methods versus using a robotic exoskeleton. It looks at how soon patients start walking and checks the safety and practicality of using robots in recovery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Overground robotic exoskeleton early ambulation (ORE-EA)Experimental Treatment1 Intervention
Group II: Usual care early ambulation (UC-EA)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials
210
Recruited
205,000+

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