ERIGO® Life - Study of Cardiovascular Parameters and Other Physiologic Parameters Under Verticalization and Simultaneous Mobilization of the Leg on Neurological Patients and Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of participants with adverse event as a measure of safety and tolerability
研究概览
简要总结
Early verticalization and stepping with the equipment of Hocoma ERIGO during monitoring of vital parameters. The device is already CE marked and, for the purposes of the study, will be used in accordance with the intended use (after-market clinical investigation).
详细描述
In early rehabilitation of neurological patients, safe mobilization and intensive sensorimotor stimulation are key factors for therapeutic success. Early activation and stimulation of the patient intend enhancement of neuroplasticity and recovery. Furthermore, it improves the patient's communication and cooperation skills and counteracts secondary damages due to immobilization.
The study combines gradual verticalization during monitoring of vital parameters, with cyclic leg movement and foot loading. The table to ensures the necessary safety for the stabilization of the patient in the upright position. The patient stimulation is additionally enhanced by synchronized functional electrical stimulation (FES). By providing a safe solution for early mobilization, the Erigo counteracts the negative effects of immobility and accelerates the recovery process through intensive sensorimotor stimulation. It is the first choice therapy device for the early and safe mobilization of severely impaired, bed-ridden patients even in acute care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •minimum 18 years old
- •normal response to verbal instructions
- •oxygen saturation of the blood at least 92%
- •healthy german speaking men and women
- •non-smoker
- •heartbeat 40-100
- •systolic blood pressure 120 to 220 mmHg
- •in patients: post acute phase: stroke or other neurological functional disorder
排除标准
- •severe contraction in the legs (Ashworth >3)
- •pregnancy
- •acute pain syndrome
- •severe cardio-pulmonary disease
- •history of orthostatic dysregulation
- •thrombophlebitis
- •renal disease
- •contraindication for electric stimulation (instable epilepsy, cancer, pacemaker, palliative care)
- •weight > 120kg
- •height > 210 cm
- •skin lesions on legs
研究组 & 干预措施
Single-arm study
Early mobilization of patients after stroke or spinal cord injury. Monitoring of vital parameters during mobilization of healthy subjects
干预措施: Erigo (Device)
结局指标
主要结局
Number of participants with adverse event as a measure of safety and tolerability
时间窗: Up to 8 hours
Control of cardiovascular parameters at desired ranges at healthy and at patients
次要结局
未报告次要终点
研究者
Verena Klamroth
Dr. med.
Swiss Federal Institute of Technology