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

Stroke Clinical Trial

— ERIGO®LIFE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268266
• Other study ID #: ERIGO LIFE StV 22_2009
• Status: Completed
• Phase: N/A
• First received: July 31, 2014
• Last updated: November 17, 2015
• Start date: April 2010
• Est. completion date: March 2015

Study information

• Verified date: November 2015
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Stroke

Intervention

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

Locations

Country	Name	City	State
Switzerland	Zürcher Höhenklinik Wald	Wald	Zurich
Switzerland	ETH Zurich	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Hocoma AG, Switzerland, Zuercher Hoehenklinik Wald

Country where clinical trial is conducted

Switzerland, 

Outcome

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