Effects of Early Stepping Verticalization + FES on CIP

Completed

• Conditions: Acquired Brain Injury; Critical Illness Polyneuropathy
• Interventions: Device: stepping verticalization plus functional electrical stimulation; Device: stepping verticalization; Other: conventional physiotherapy

• Registration Number: NCT03616314
• Lead Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2018-07-01
• Study Completion: 2018-07-01
• Study First Submitted: 2018-07-31
• Study First Submitted QC: 2018-07-31
• Status Verified: 2018-08
• Study First Posted: 2018-08-06
• Last Update Submitted: 2018-08-11
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
stepping verticalization + FES	stepping verticalization plus functional electrical stimulation	in ICU they received conventional physiotherapy + stepping verticalization sessions with FES using ErigoPro
stepping verticalization	stepping verticalization	in ICU they received conventional physiotherapy + stepping verticalization sessions with Erigo
conventional physiotherapy	conventional physiotherapy	in ICU they received only conventional physiotherapy

Primary Outcome Measures

Name	Time	Method
CIP occurrence	at enrollment	Presence of critical illness polyneuropathy at the end of ICU stay

Secondary Outcome Measures

Name	Time	Method
motricity index	at enrollment	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)
Functional Ambulation Classification (FAC)	at enrollment	Functional Ambulation Classification score at neurorehabilitation discharge. Scale goes from 0 (no ambulation) to 5 (independent ambulation)

Trial Locations

Locations (1)

Ospedale Generale di Zona Moriggia Pelascini; 🇮🇹 Gravedona, CO, Italy