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.
Above age of 18 years old,
Having undergone thoracic surgery that necessitated admission in the TSICU.
Debilitated as defined as a JH-HLM score of 5 or less
Height < 6'3 feet or weight > 220 lbs restrictions
Severe muscular spasticity of the lower extremities (Modified Ashworth Scale Grade 3 higher).
Current fractures or incomplete bone junctions in the spine, pelvis, and/or lower extremities
Osteoporosis or lower bone mineral density -3.5, and history(ies) of osteoporotic fracture(s).
Single group
Self-balancing robotic exoskeleton (Atalante X)
DeviceThis intervention consists of early mobilization sessions using the Atalante X, a self-balancing robotic exoskeleton (Wandercraft). Unlike other exoskeletons that require external support or crutches, this device is fully self-stabilizing and allows patients to stand and walk hands-free. It provides both passive and active modes, enabling short steps (EarlyGait) and longer steps (RealGait), with adjustable levels of assistance tailored to each patient's capacity. Sessions are performed 2-3 times per week for up to 2 weeks or until ICU discharge.
Incidence of device- and procedure-related adverse events during exoskeleton use in ICU patients
Safety will be assessed by the rate and type of device- and procedure-related adverse events during exoskeleton use. This includes skin lesions, catheter dislodgement, hemodynamic instability, falls, or any serious adverse events (SAEs or SADEs). An acceptable rate is defined as \<15% overall and \<15% for skin lesions.
To evaluate the feasibility of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Outcome: Compliance Measure Description: Compliance (%) = (number of completed exoskeleton sessions ÷ number of expected sessions) × 100. Expected sessions are fixed at 2 per week during the ICU stay. Sessions beyond 2 per week count as completed sessions but do not increase the expected total. Unit of Measure: percent (%)
To evaluate the feasibility of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Outcome: Session Duration Measure Description: Duration of each exoskeleton session; mean duration per participant across all sessions. Unit of Measure: minutes
To evaluate the feasibility of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Outcome: Total Steps per Session Measure Description: Number of steps completed during each exoskeleton session; mean steps per participant across sessions. Unit of Measure: steps
To evaluate the feasibility of the self-balanced exoskeleton Atalante X among patients in the intensive care unit (ICU) who have undergone thoracic surgery
Outcome: Duration by Walking Mode Measure Description: Time spent in each walking mode during exoskeleton sessions. EarlyGait and RealGait are reported separately; for each mode, the participant's mean duration across sessions is calculated. Unit of Measure: minutes
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