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Recruiting NCT07353892

NCT07353892 Robotic Exoskeletons in Acute Care Therapy

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Clinical Trial Summary
NCT ID NCT07353892
Status Recruiting
Phase
Sponsor Baylor Research Institute
Condition Patients Post-cardiothoracic Surgery
Study Type INTERVENTIONAL
Enrollment 20 participants
Start Date 2025-12-02
Primary Completion 2027-01-01

Trial Parameters

Condition Patients Post-cardiothoracic Surgery
Sponsor Baylor Research Institute
Study Type INTERVENTIONAL
Phase N/A
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-12-02
Completion 2027-01-01
Interventions
Overground robotic exoskeleton early ambulation (ORE-EA)Usual care early ambulation (UC-EA)

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Brief 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. 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?

Eligibility Criteria

Inclusion Criteria: 1. Age ≥ 18 years 2. 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 \[transplant, durable or temporary ventricular assist device implantation (VAD), temporary mechanical circulatory support (tMCS), venovenous extracorporeal membrane oxygenation (VV ECMO)\]. 3. 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. 4. Requires ≥ 50% assist to perform upright activity based on physical therapy assessments (e.g., AMPAC-6 clicks or JH-HLM) 5. English or Spanish-speaking 6. Able to provide written informed consent (or via a legally authorized representative if applicable) 7. Meets ORE frame limitations (height = 5'2" to 6'4" and weight ≤ 220 lbs.) Exclusion Criteria: 1. Co

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