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Clinical Trials/NCT03616314
NCT03616314CompletedNot Applicable

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

Ospedale Generale Di Zona Moriggia-Pelascini1 site in 1 country39 target enrollmentStarted: June 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
39
Locations
1
Primary Endpoint
CIP occurrence

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

CIP occurrence

Time Frame: at enrollment

Presence of critical illness polyneuropathy at the end of ICU stay

Secondary Outcomes

  • motricity index(at enrollment)
  • Functional Ambulation Classification (FAC)(at enrollment)

Investigators

Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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