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

Not Applicable

Completed

• Conditions: Stroke; Spinal Cord Injury
• Interventions: Device: Erigo

• Registration Number: NCT02268266
• Lead Sponsor: Swiss Federal Institute of Technology

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2014-07-31
• Study First Submitted QC: 2014-10-15
• Study First Posted: 2014-10-20
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-arm study	Erigo	Early mobilization of patients after stroke or spinal cord injury. Monitoring of vital parameters during mobilization of healthy subjects

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Zürcher Höhenklinik Wald; 🇨🇭 Wald, Zurich, Switzerland

ETH Zurich; 🇨🇭 Zurich, Switzerland