MedDataX Logo

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

NCT ID: NCT02268266

Last Updated: 2015-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Spinal Cord Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single-arm study

Early mobilization of patients after stroke or spinal cord injury. Monitoring of vital parameters during mobilization of healthy subjects

Group Type OTHER

Erigo

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Erigo

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Erigo rehabilitation bed from Hocoma AG, Switzerland.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zuercher Hoehenklinik Wald

OTHER

Sponsor Role collaborator

Hocoma AG, Switzerland

UNKNOWN

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Verena Klamroth

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert Riener, Prof.Dr.-Ing

Role: PRINCIPAL_INVESTIGATOR

Swiss Federal Institut of Technology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zürcher Höhenklinik Wald

Wald, Canton of Zurich, Switzerland

Site Status

ETH Zurich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ERIGO LIFE StV 22_2009

Identifier Type: -

Identifier Source: org_study_id