NCT07220733 · Wandercraft
Safety and Feasibility of a Self-Balancing Exoskeleton for Rehabilitation in the Thoracic Surgical Intensive Care Unit: a Pilot Trial
(HEART)
What this study 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.
View original scientific description
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.
Interventions
DEVICE
Self-balancing robotic exoskeleton (Atalante X)
This 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.
Primary outcome measures
Incidence of device- and procedure-related adverse events during exoskeleton use in ICU patients
Time frame: Baseline and through study completion, an average of 2 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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).
- Skin disorders including Stage I pressure injuries at the hip, lower limbs, and Exoskeleton contact areas, according to the National and European Pressure Ulcer Classification System (NPUAP-EPUAP).
- Severe arthritis, acute arthritis, or synovitis after total or partial lower limb joint replacement.
- Myocardial infarction or angina or ischemic heart disease within the last 6 months.
- Uncorrectable leg length discrepancy over 2 cm when using additional correction tools.
- III-IV spine scoliotic deformity.
- Amputations and lower limb prostheses.
- Adults who lack the capacity to provide informed consent
- Cardiovascular instability as indicated by:
- Presence of unstable ventricular or atrial arrhythmias
- HR \< 40 or HR \> 140
- Lactate \> 4.0 mmol/L
- On moderate-high dose vasopressors/inotropes
- Currently on VA ECMO
- Respiratory instability as indicated by:
- FiO2 \> 0.6
- PEEP \> 12 cm H2O
- RR \> 35 bpm
- Currently on VV-ECMO
- Unable to follow commands
- Has bed rest orders
Where
- Boston, Massachusetts
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Frequently asked questions
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Will I receive a placebo instead of treatment?
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Data: ClinicalTrials.gov · synced Oct 24, 2025 · Source of record for eligibility and locations