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

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).

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Key information

Conditions

Stroke Brain Diseases Brain Injuries Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zürcher Höhenklinik Wald, Wald, Canton of Zurich, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erigo

Device

The control of cardiovascular parameters within suitable ranges for healthy and neurological patients using verticalization, leg mobilization and electrical stimulation

Other names: Erigo rehabilitation bed from Hocoma AG, Switzerland.

Primary outcomes

Number of participants with adverse event as a measure of safety and tolerability

Time frame: Up to 8 hours

Control of cardiovascular parameters at desired ranges at healthy and at patients

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

Hocoma AG, Switzerland
Zuercher Hoehenklinik Wald

Registry information

Official study title

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

Acronym: ERIGO®LIFE

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Oct 20, 2014
Registry last updated: Nov 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed