NCT07353892招募中不适用
Robotic Exoskeletons in Acute Care Therapy - Cardiovascular and Thoracic Surgery
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time to ambulation
研究概览
简要总结
The goal of this clinical trial is to establish the safety, feasibility, and preliminary findings of overground robotic exoskeleton early ambulation (ORE-EA) compared to usual care early ambulation (UC-EA) in the rehabilitation of patients who have had cardiovascular or thoracic surgery. The main questions it aims to answer are:
- Is there a difference between groups in time between surgery and ambulation?
- Are there differences in safety and feasibility?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Underwent cardiovascular or thoracic surgery, including but not limited to coronary artery bypass grafting, valve replacement/repair, lung resection, or advanced cardiovascular or pulmonary therapies [transplant, durable or temporary ventricular assist device implantation (VAD), temporary mechanical circulatory support (tMCS), venovenous extracorporeal membrane oxygenation (VV ECMO)].
- •Medically appropriate for physical therapy, including upright activity and ambulation, as defined by an order in the patient's electronic medical record signed by a physician or advanced practice provider.
- •Requires ≥ 50% assist to perform upright activity based on physical therapy assessments (e.g., AMPAC-6 clicks or JH-HLM)
- •English or Spanish-speaking
- •Able to provide written informed consent (or via a legally authorized representative if applicable)
- •Meets ORE frame limitations (height = 5'2" to 6'4" and weight ≤ 220 lbs.)
排除标准
- •Cognitive or behavioral impairment that interferes with safe participation [e.g., active delirium (positive CAM-ICU score) or unable to follow commands].
- •Moderate vasopressor or inotrope requirements, including:
- •>0.10 mcg/kg/min of norepinephrine >0.03 mcg/kg/min of epinephrine >80.0 mcg/kg/min of phenylephrine >0.04 units/min of vasopressin >5.0 mcg/kg/min of dobutamine >5.0 mcg/kg/min dopamine >0.50 mcg/kg/min of milrinone Any combination of > 3 of any of these, regardless of dose, unless deemed acceptable at the discretion of the treating attending.
- •Sustained ventricular arrhythmias that require intervention at the time of upright mobilization.
- •Any active dose of angiotensin II
- •Positive end-expiratory pressure (PEEP) ≥ 10 cm H20).
- •Except for those with a femoral arterial balloon pump, all patients with existing femoral arterial lines at the time of ambulation are ineligible. However, patients with femoral intraortic balloon pump (IABP) may be considered if, in the judgment of the attending physician and physical therapy team, patient is appropriate for ambulation given patient's clinical status and IABP site and securement status, and if ambulation of appropriate patients with femoral IABP is consistent with local standard of care at the time of ambulation.
- •Skin disintegrity in proximity to the ORE frame
- •Participation in another interventional study that may confound outcome measures.
- •Any other condition that, in the judgment of the clinical or research team, would pose an unacceptable risk or interfere with study participation or interpretation.
研究组 & 干预措施
Overground robotic exoskeleton early ambulation (ORE-EA)
Experimental
Overground robotic exoskeleton early ambulation (ORE-EA)
干预措施: Overground robotic exoskeleton early ambulation (ORE-EA) (Device)
Usual care early ambulation (UC-EA)
Active Comparator
Standard of care
干预措施: Usual care early ambulation (UC-EA) (Other)
结局指标
主要结局
Time to ambulation
时间窗: From the date of ICU admission until the date of first documented upright ambulation session, up to 12 months.
Time from admission in the ICU to the first upright ambulation session (in hours), assessed up to 12 months from admission.
Ambulation dosage
时间窗: From first ambulation session through study completion, expected to be less than 1 year
Step count, total "up time" (minutes), and "walk time" (minutes) measured during each early-ambulation session
次要结局
- Adverse events of special interest(From first ambulation session through study completion, expected to be less than 1 year)
- Feasibility of Overground Robotic Exoskeleton Early Ambulation (ORE-EA) -1(From first ambulation session through study completion, expected to be less than 1 year)
- Feasibility of Overground Robotic Exoskeleton Early Ambulation (ORE-EA) -2(From first ambulation session through study completion, expected to be less than 1 year)
研究者
研究点 (1)
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