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

Primary Purpose

Stroke, Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Erigo
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring brain injury, early rehabilitation, tilt table

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Zürcher Höhenklinik Wald
  • ETH Zurich

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single-arm study

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 31, 2014
Last Updated
November 17, 2015
Sponsor
Swiss Federal Institute of Technology
Collaborators
Zuercher Hoehenklinik Wald, Hocoma AG, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT02268266
Brief Title
ERIGO® Life- Control of Cardiovascular Parameters Via Verticalization and Simultaneous Mobilization
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
Zuercher Hoehenklinik Wald, Hocoma AG, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spinal Cord Injury
Keywords
brain injury, early rehabilitation, tilt table

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-arm study
Arm Type
Other
Arm Description
Early mobilization of patients after stroke or spinal cord injury. Monitoring of vital parameters during mobilization of healthy subjects
Intervention Type
Device
Intervention Name(s)
Erigo
Other Intervention Name(s)
Erigo rehabilitation bed from Hocoma AG, Switzerland.
Intervention Description
The control of cardiovascular parameters within suitable ranges for healthy and neurological patients using verticalization, leg mobilization and electrical stimulation
Primary Outcome Measure Information:
Title
Number of participants with adverse event as a measure of safety and tolerability
Description
Control of cardiovascular parameters at desired ranges at healthy and at patients
Time Frame
Up to 8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Riener, Prof.Dr.-Ing
Organizational Affiliation
Swiss Federal Institut of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zürcher Höhenklinik Wald
City
Wald
State/Province
Zurich
ZIP/Postal Code
8636
Country
Switzerland
Facility Name
ETH Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

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

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