Robotic exoskeletons for early walking after heart or chest surgery

Robotic Exoskeletons in Acute Care Therapy - Cardiovascular and Thoracic Surgery

This will try using a wearable robotic exoskeleton to help adults who had heart or chest surgery get up and walk sooner compared with usual early ambulation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Baylor Research Institute (Academic / other)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT07353892 on ClinicalTrials.gov

What this trial studies

Adults who have undergone cardiovascular or thoracic surgery and meet size and medical criteria will be assigned to overground robotic exoskeleton early ambulation (ORE-EA) or to usual care early ambulation (UC-EA). The study measures time from surgery to first ambulation and monitors safety and feasibility outcomes, including device-related issues and staff assistance needs. Participants must be medically cleared for upright activity and require at least 50% assist on physical therapy assessment. The single-center trial is conducted at Baylor Institute for Rehabilitation in Dallas, Texas.

Who should consider this trial

Good fit: Adults (≥18) who recently had cardiovascular or thoracic surgery, are medically cleared for upright activity, require ≥50% assist for upright activity, speak English or Spanish, and fit the exoskeleton (5'2"–6'4", ≤220 lb) are ideal candidates.

Not a fit: Patients who cannot fit the device, are not medically cleared to ambulate, or who already walk independently are unlikely to benefit from the robotic exoskeleton intervention.

Why it matters

Potential benefit: If successful, this approach could allow patients to walk sooner and do so safely after cardiothoracic surgery, which may reduce complications and speed recovery.

How similar studies have performed: Robotic exoskeletons have shown promise in rehabilitation settings such as stroke and spinal cord injury, but their specific use for immediate early ambulation after cardiothoracic surgery is relatively untested.

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. Cognitive or behavioral impairment that interferes with safe participation \[e.g., active delirium (positive CAM-ICU score) or unable to follow commands\].
2. Moderate vasopressor or inotrope requirements, including:

   \>0.10 mcg/kg/min of norepinephrine \>0.03 mcg/kg/min of epinephrine \>80.0 mcg/kg/min of phenylephrine \>0.04 units/min of vasopressin \>5.0 mcg/kg/min of dobutamine \>5.0 mcg/kg/min dopamine \>0.50 mcg/kg/min of milrinone Any combination of \> 3 of any of these, regardless of dose, unless deemed acceptable at the discretion of the treating attending.
3. Sustained ventricular arrhythmias that require intervention at the time of upright mobilization.
4. Any active dose of angiotensin II
5. Positive end-expiratory pressure (PEEP) ≥ 10 cm H20).
6. Except for those with a femoral arterial balloon pump, all patients with existing femoral arterial lines at the time of ambulation are ineligible. However, patients with femoral intraortic balloon pump (IABP) may be considered if, in the judgment of the attending physician and physical therapy team, patient is appropriate for ambulation given patient's clinical status and IABP site and securement status, and if ambulation of appropriate patients with femoral IABP is consistent with local standard of care at the time of ambulation.
7. Skin disintegrity in proximity to the ORE frame
8. Participation in another interventional study that may confound outcome measures.
9. Pregnancy
10. 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.

Where this trial is running

Dallas, Texas

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

Study contacts

• Study coordinator: Katelyn D Bosteder

Conditions Patients Post-cardiothoracic Surgery; cardiothoracic surgery; rehabilitation; ambulation