Status:
RECRUITING
Safety and Feasibility of a Self-Balancing Exoskeleton for Rehabilitation in the Thoracic Surgical Intensive Care Unit: a Pilot Trial
Lead Sponsor:
Wandercraft
Conditions:
Critical Illness
Post Operative Complication
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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. Ea...
Detailed Description
Prolonged bed rest and immobility are common in ICU patients and are strongly associated with poor outcomes, including pulmonary complications, neuromuscular weakness, cognitive impairment, and delaye...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT07220733
Start Date
October 1 2025
End Date
February 1 2026
Last Update
October 24 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115