Effects of Early Stepping Verticalization + FES on CIP

Ospedale Generale Di Zona Moriggia-Pelascini

Status: Completed

Conditions: Acquired Brain Injury; Critical Illness Polyneuropathy

Treatments: Other: conventional physiotherapy; Device: stepping verticalization plus functional electrical stimulation; Device: stepping verticalization

Study type: Observational

Funder types: Other

Identifiers

NCT03616314

Erigo/FES critical illness

Details and patient eligibility

About

Background: Intensive Care Unit (ICU) survivors often develop an acquired weakness due to a Critical Illness Polyneuropathy (CIP). Early mobilization in ICU, by reducing the bed rest and decreasing the oxidative stress, was shown to represent a valid preventive option.

Purpose: To evaluate whether ICU sessions of stepping verticalization associated with Functional Electrical Stimulation (FES) of the lower limbs are able to reduce the occurrence of CIP in Acquired Brain Injured (ABI) patients.

Methods: all the ABI patients admitted in our Neurorehabilitation Unit from our ICU were retrospectively evaluated. Patients affected by previous peripheral neuropathy, diabetes, cancer, alcoholism, viral hepatitis, AIDS and autoimmune diseases were excluded. They were divided into 3 groups according to the rehabilitation strategy received in ICU: group 1 received conventional physiotherapy + stepping verticalization sessions with Erigo® (Hocoma, Switzerland); group 2 received conventional physiotherapy + stepping verticalization sessions with FES using ErigoPro®; group 3 received only conventional physiotherapy. As for internal protocol, all patients started rehabilitation in the first week from the ABI and performed 60 minutes/day of rehabilitation, 5 days/week. Primary outcome was the evidence of CIP at Neurorehabilitation admission (=ICU discharge), according to neurophysiological criteria. Secondary outcomes were the strength impairment at Neurorehabilitation discharge, measured by the total Motricity Index score and the Functional Ambulation Classification (FAC) score, assessing quality of gait.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• arriving directly from our acute care facility
• hospitalized in ICU due to an acute brain injury

Exclusion criteria

• previous peripheral neuropathies
• diabetes
• cancer
• alcoholism
• viral hepatitis
• AIDS
• autoimmune diseases
• absence of clinical or neurophysiological informations at data collection

Trial design

39 participants in 3 patient groups

stepping verticalization

Description:

in ICU they received conventional physiotherapy + stepping verticalization sessions with Erigo

Treatment:

Device: stepping verticalization

stepping verticalization + FES

Description:

in ICU they received conventional physiotherapy + stepping verticalization sessions with FES using ErigoPro

Treatment:

Device: stepping verticalization plus functional electrical stimulation

conventional physiotherapy

Description:

in ICU they received only conventional physiotherapy

Treatment:

Other: conventional physiotherapy