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Studies

Interventional Recruiting

NCT07353892 on ClinicalTrials.gov

Robotic Exoskeletons in Acute Care Therapy

Official title: Robotic Exoskeletons in Acute Care Therapy - Cardiovascular and Thoracic Surgery

  • Sponsor: Baylor Scott & White Research Institute
  • Enrollment: 20 (Estimated)
  • Study start: 2025-12-02 (Actual)
  • Primary completion: 2027-01-01 (Estimated)
  • Study completion: 2027-07-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Subjects will be randomized to experimental treatment vs. Standard -of care treatment in 2:1 ratio
  • Masking: None
  • PrimaryPurpose: Supportive Care

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?

Conditions

  • Patients Post-cardiothoracic Surgery

Intervention / Treatment

  • Device: Overground robotic exoskeleton early ambulation (ORE-EA)
  • Other: Usual care early ambulation (UC-EA)

Primary Outcome Measures

  • Time to ambulation (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 (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

Countries

United States

Locations and Investigators

  • Baylor Institute for Rehabilitation, Dallas, United States (Recruiting)