20 Participants Needed

Robotic Exoskeletons for Post-Surgery Recovery

(REACT-CVTS Trial)

KD
Overseen ByKatelyn D Bosteder
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?

This trial explores the use of a robotic exoskeleton for walking after cardiovascular or thoracic surgery to aid recovery compared to standard care. Researchers aim to determine if patients can begin walking sooner and assess the safety and practicality of this technology. The trial seeks participants who have undergone major heart or lung surgery and require additional support to get up and move. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve recovery options for future patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, certain medications like moderate vasopressors or inotropes are part of the exclusion criteria, so it's best to discuss your specific medications with the trial team.

What prior data suggests that this robotic exoskeleton is safe for post-surgery recovery?

Research has shown that overground robotic exoskeletons, like those studied for recovery after surgery, have generally been well-received in earlier trials. These studies found that they help people walk faster and improve their walking style. So far, no major safety issues have been reported. Unexpected problems have been rare, and most participants completed their therapy sessions without trouble. This technology has been tested in various environments, showing promising results in helping people regain movement after surgery.12345

Why are researchers excited about this trial?

Researchers are excited about the use of overground robotic exoskeletons for post-surgery recovery because they offer a new approach to early ambulation. Unlike the standard care that mainly relies on traditional physical therapy, these exoskeletons provide mechanical support that can help patients walk sooner and potentially improve recovery times. The technology allows for precise control of movement, which can aid in regaining mobility more efficiently. This innovative method could revolutionize how we assist patients in their recovery journey, making the rehabilitation process faster and possibly more effective.

What evidence suggests that overground robotic exoskeleton early ambulation is effective for post-surgery recovery?

This trial will compare overground robotic exoskeleton early ambulation (ORE-EA) with usual care early ambulation (UC-EA) for post-surgery recovery. Studies have shown that overground robotic exoskeletons can help people walk faster and with fewer issues. Research indicates these devices effectively improve walking in stroke patients. One study found that this technology enhanced walking speed and movement across various groups. In terms of safety, these exoskeletons have been well-tolerated, with no serious side effects reported. These findings suggest that robotic exoskeletons may help patients regain their ability to walk after surgery.12567

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+

Citations

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) ...

Overground Robot Exoskeleton Gait Training - Stroke Patients

The results of this study indicate that overground robot exoskeleton gait training is effective at improving gait speed in patients with stroke.

Utilization of Robotic Exoskeleton for Overground Walking ...

The results demonstrated an increase in walking speed, functional ambulation category, and a decrease in gait deviations from baseline to follow ...

Overground Robotic Exoskeletons for Early Mobility in ...

Outcomes were safety (adverse events), tolerability [session metrics (up time, walk time, step count) and vital signs], and highest level of ...

Robotic Exoskeletons for Post-Surgery Recovery

The study compares two ways of helping patients walk after surgery: usual care with standard methods versus using a robotic exoskeleton. It ...

Robotic Exoskeletons in Acute Care Therapy | MedPath

The goal of this clinical trial is to establish the safety, feasibility, and preliminary findings of overground robotic exoskeleton early ...

Utilization of Robotic Exoskeleton for Overground Walking ...

The results demonstrated an increase in walking speed, functional ambulation category, and a decrease in gait deviations from baseline to follow ...