Robotic Exoskeletons in Acute Care Therapy

Conditions

• Patients Post-cardiothoracic Surgery

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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 Details

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?

Key Dates

Start date

Dec 2, 2025

Status verified

Jan 2026

Primary completion

Jan 1, 2027

Completion

Jul 1, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Overground robotic exoskeleton early ambulation (ORE-EA)
  Overground robotic exoskeleton early ambulation (ORE-EA)
• Active Comparator: Usual care early ambulation (UC-EA)
  Standard of care

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. ]

Central Contacts

• Katelyn D Bosteder
  214-820-6187
  [email protected]

Locations (1)

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