Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT07220733
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07220733
Study Brief:
Protocol Section:
NCT07220733