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

November 17, 2015 updated by: Verena Klamroth, Swiss Federal Institute of Technology

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • ETH Zürich
    • Zurich
      • Wald, Zurich, Switzerland, 8636
        • Zürcher Höhenklinik Wald

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single-arm study
Early mobilization of patients after stroke or spinal cord injury. Monitoring of vital parameters during mobilization of healthy subjects
Device: Erigo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Collaborators

Zuercher Hoehenklinik Wald
Hocoma AG, Switzerland

Investigators

  • Principal Investigator: Robert Riener, Prof.Dr.-Ing, Swiss Federal Institut of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

October 15, 2014

First Posted (Estimate)

October 20, 2014

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERIGO LIFE StV 22_2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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