ERIGO® Life- Control of Cardiovascular Parameters Via Verticalization and Simultaneous Mobilization

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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ERIGO® Life - Study of Cardiovascular Parameters and Other Physiologic Parameters Under Verticalization and Simultaneous Mobilization of the Leg on Neurological Patients and Healthy Subjects

Conditions
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Stroke, Spinal Cord Injury

Intervention / Treatment
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* Device: Erigo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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 Exclusion criteria: severe contraction in the legs (Ashworth >3) pregnancy acute pain syndrome severe cardio-pulmonary disease history of orthostatic dysregulation thrombophlebitis diabetes renal disease contraindication for electric stimulation (instable epilepsy, cancer, pacemaker, palliative care) weight > 120kg height > 210 cm skin lesions on legs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single-arm study<br>Early mobilization of patients after stroke or spinal cord injury. Monitoring of vital parameters during mobilization of healthy subjects | Device: Erigo<br>* The control of cardiovascular parameters within suitable ranges for healthy and neurological patients using verticalization, leg mobilization and electrical stimulation<br>* Other names: Erigo rehabilitation bed from Hocoma AG, Switzerland.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse event as a measure of safety and tolerability | Control of cardiovascular parameters at desired ranges at healthy and at patients | Up to 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain injury, early rehabilitation, tilt table