Self-balancing exoskeleton to support rehabilitation after thoracic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.