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

Federal Institute of Technology (ETH) Zurich

Status: Completed

Conditions: Stroke; Spinal Cord Injury

Treatments: Device: Erigo

Study type: Interventional

Funder types: Other

Identifiers

NCT02268266

ERIGO LIFE StV 22_2009

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Single-arm study

Other group

Description:

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

Treatment:

Device: Erigo