Self-balancing exoskeleton to support rehabilitation after thoracic surgery
Safety and Feasibility of a Self-Balancing Exoskeleton for Rehabilitation in the Thoracic Surgical Intensive Care Unit: a Pilot Trial
This trial will test whether a wearable self-balancing exoskeleton (Atalante X) can help adults recovering from thoracic surgery stand and walk more safely in the ICU.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wandercraft Industry-sponsored |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07220733 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm pilot conducted in the Thoracic Surgical ICU at Brigham and Women's Hospital using the Atalante X self-balancing robotic exoskeleton. Eligible adult patients who are debilitated after thoracic surgery (JH-HLM ≤ 5) will receive individualized exoskeleton sessions up to 2–3 times per week for a maximum of two weeks, with progressive standing and walking as tolerated. The study will focus on safety and feasibility outcomes, monitoring vital signs, device tolerability, and any adverse events while documenting mobility gains and staff assistance requirements. Results will inform whether this device can be integrated into early ICU rehabilitation workflows.
Who should consider this trial
Good fit: Adults (age ≥18) admitted to the Thoracic Surgical ICU after thoracic surgery who are debilitated (JH-HLM score ≤ 5) and who meet the device size and medical safety criteria are ideal candidates.
Not a fit: Patients with disqualifying conditions such as severe lower-extremity spasticity, recent unstable cardiac events, unhealed fractures, severe osteoporosis, significant skin breakdown at contact sites, or those outside the device height/weight limits are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could help patients stand and walk earlier after thoracic surgery, reduce complications related to immobility, and lessen the physical burden on staff.
How similar studies have performed: Previous clinical work with the Atalante X in spinal cord injury and post-stroke populations demonstrated safety and feasibility with mobility gains, but its use in the immediate postoperative ICU setting is a novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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. * Pregnancy * 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 this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Raghu Seethala
- Email: RSEETHALA@BWH.HARVARD.EDU
- Phone: 617-525-3150
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.