Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT07220733

Safety and Feasibility of a Self-Balancing Exoskeleton for Rehabilitation in the Thoracic Surgical Intensive Care Unit: a Pilot Trial

Led by Wandercraft · Updated on 2025-10-24

5

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Patients admitted to the Intensive Care Unit (ICU) after thoracic surgery often experience complications related to immobility, such as muscle weakness, pulmonary issues, and longer recovery times. Early mobilization has been shown to improve outcomes, but its implementation is often limited by patient fragility and staff resources. This study will test the safety and feasibility of using the Atalante X, a self-balancing exoskeleton, in the Thoracic Surgical ICU at Brigham and Women's Hospital. The exoskeleton is designed to support patients in standing and walking, even if they have limited strength or balance, thereby reducing the physical burden on healthcare staff and increasing patient mobility. Eligible participants are adults recovering from thoracic surgery, who are debilitated (Johns Hopkins Highest Level of Mobility scale ≤ 5). Each participant will undergo up to 2-3 exoskeleton sessions per week for a maximum of 2 weeks. Sessions will be personalized, with progressive standing time and walking depending on patient tolerance. The primary goal is to evaluate the safety of exoskeleton use, measured by adverse events such as skin lesions, cardiovascular instability, or accidental device-related issues. The secondary goals are to evaluate: Feasibility (ability to deliver sessions as planned, duration of standing/walking, level of assistance needed), Usability (patient and staff satisfaction, ease of donning/doffing, staff workload), and Preliminary effectiveness (improvement in mobility scores at discharge). Results will provide early insights into whether robotic exoskeletons can be safely integrated into ICU rehabilitation programs after thoracic surgery.

CONDITIONS

Official Title

Safety and Feasibility of a Self-Balancing Exoskeleton for Rehabilitation in the Thoracic Surgical Intensive Care Unit: a Pilot Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Admitted to the Thoracic Surgical ICU after thoracic surgery
  • Debilitated with a Johns Hopkins Highest Level of Mobility score of 5 or less
Not Eligible

You will not qualify if you...

  • Height 6 feet 3 inches or taller or weight over 220 pounds
  • Severe muscle stiffness in lower limbs (Modified Ashworth Scale Grade 3 or higher)
  • Current fractures or incomplete bone healing in spine, pelvis, or lower limbs
  • Osteoporosis with bone density below -3.5 or history of osteoporotic fractures
  • Skin disorders including Stage I pressure injuries on hips, lower limbs, or exoskeleton contact areas
  • Severe or acute arthritis or synovitis after lower limb joint replacement
  • Heart attack, angina, or ischemic heart disease in the last 6 months
  • Leg length difference over 2 cm not correctable with tools
  • Severe spine curvature (Grade III-IV scoliosis)
  • Amputations or use of lower limb prostheses
  • Pregnancy
  • Unable to provide informed consent
  • Cardiovascular instability such as unstable arrhythmias, heart rate below 40 or above 140, high blood lactate, use of moderate to high doses of vasopressors/inotropes, or on VA ECMO
  • Respiratory instability including high oxygen needs (FiO2 > 0.6), high PEEP (>12 cm H2O), rapid breathing (>35 breaths per minute), or on VV ECMO
  • Unable to follow commands
  • Bed rest orders

AI-Screening

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Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

R

Raghu Seethala

CONTACT

S

Stephanie KORLE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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