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Tests treatment safety and results for Critical Illness
Official title Safety and Feasibility of a Self-Balancing Exoskeleton for Rehabilitation in the Thoracic Surgical Intensive Care Unit: a Pilot Trial
ClinicalTrials.gov ID: NCT07220733
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Height \ 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...
- Severe arthritis, acute arthritis, or synovitis after total or partial lower limb joint replacement.
See the full eligibility 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
- Height \ 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 \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.