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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02268266

Acronym

ERIGO®LIFE

Enrollment

Registered

2014-10-20

Start date

2010-04-30

Completion date

2015-03-31

Last updated

2015-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury, Stroke

Keywords

brain injury, early rehabilitation, tilt table

Brief summary

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

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.

Interventions

DEVICEErigo

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026