Effects of Early Stepping Verticalization + FES on CIP

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Effects of Early Stepping Verticalization With or Without FES Compared to Conventional Physiotherapy on the Occurrence of Critical Illness Polyneuropathy in Patients Affected by Acquired Brain Injury: a Retrospective Study

Conditions
-----------------
Critical Illness Polyneuropathy, Acquired Brain Injury

Intervention / Treatment
-----------------
* Device: stepping verticalization plus functional electrical stimulation
* Device: stepping verticalization
* Other: conventional physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| stepping verticalization<br>in ICU they received conventional physiotherapy + stepping verticalization sessions with Erigo | Device: stepping verticalization<br>* patients receive 30 minutes/day of conventional physiotherapy + 30 minutes7day of verticalization using a tilt table with a robotic stepping device<br>|
| stepping verticalization + FES<br>in ICU they received conventional physiotherapy + stepping verticalization sessions with FES using ErigoPro | Device: stepping verticalization plus functional electrical stimulation<br>* patients hospitalized in ICU are rehabilitated using 30 minutes/day of conventional physiotherapy + 30 minutes/day of verticalization using a tilt table with an integrated robotic stepping device synchronized with an electrical stimulation of the lower limbs muscles<br>|
| conventional physiotherapy<br>in ICU they received only conventional physiotherapy | Other: conventional physiotherapy<br>* patients are treated only with 60 minutes/day of conventional physiotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CIP occurrence | Presence of critical illness polyneuropathy at the end of ICU stay | at enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| motricity index | total motricity index score (4 limbs) at neurorehabilitation discharge. Score goes from 0 (no movement in any limb) to 400 (full strength in alla limbs) | at enrollment | 
| Functional Ambulation Classification (FAC) | Functional Ambulation Classification score at neurorehabilitation discharge. Scale goes from 0 (no ambulation) to 5 (independent ambulation) | at enrollment |