Clinical trial NCT03616314: Effects of Early Stepping Verticalization + FES on CIP
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness Polyneuropathy
Acquired Brain Injury
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients hospitalized in ICU and transferred in Neurorehab after an acute brain injury

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.


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

Primary outcomes:
measure: CIP occurrence
timeFrame: at enrollment
Secondary outcomes:
measure: motricity index
timeFrame: at enrollment
measure: Functional Ambulation Classification (FAC)
timeFrame: at enrollment
Other outcomes:
Locations:
city: Gravedona
country: Italy
facility: Ospedale Generale di Zona Moriggia Pelascini
state: CO
Study officials:
References: