Effects of Early Stepping Verticalization + FES on CIP
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
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
CO
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Gravedona, CO, Italy, 22015
- Ospedale Generale di Zona Moriggia Pelascini
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
stepping verticalization
in ICU they received conventional physiotherapy + stepping verticalization sessions with Erigo
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patients receive 30 minutes/day of conventional physiotherapy + 30 minutes7day of verticalization using a tilt table with a robotic stepping device
|
|
stepping verticalization + FES
in ICU they received conventional physiotherapy + stepping verticalization sessions with FES using ErigoPro
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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
|
|
conventional physiotherapy
in ICU they received only conventional physiotherapy
|
patients are treated only with 60 minutes/day of conventional physiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CIP occurrence
Time Frame: at enrollment
|
Presence of critical illness polyneuropathy at the end of ICU stay
|
at enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
motricity index
Time Frame: 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)
|
at enrollment
|
|
Functional Ambulation Classification (FAC)
Time Frame: at enrollment
|
Functional Ambulation Classification score at neurorehabilitation discharge.
Scale goes from 0 (no ambulation) to 5 (independent ambulation)
|
at enrollment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Erigo/FES critical illness
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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