Clinical trial NCT02268266: ERIGO® Life- Control of Cardiovascular Parameters Via Verticalization and Simultaneous Mobilization
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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Spinal Cord Injury
Keywords: brain injury, early rehabilitation, tilt table
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Zuercher Hoehenklinik Wald
name: Hocoma AG, Switzerland
First posted: 2014-10-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of participants with adverse event as a measure of safety and tolerability
timeFrame: Up to 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Wald
country: Switzerland
facility: Zürcher Höhenklinik Wald
state: Zurich
city: Zurich
country: Switzerland
facility: ETH Zurich
Study officials:
affiliation: Swiss Federal Institut of Technology
name: Robert Riener, Prof.Dr.-Ing
role: PRINCIPAL_INVESTIGATOR
References: