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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03616314
Enrollment
39
Registered
2018-08-06
Start date
2018-06-01
Completion date
2018-07-01
Last updated
2018-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Brain Injury, Critical Illness Polyneuropathy

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.

Interventions

DEVICEstepping verticalization plus functional electrical stimulation

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

patients receive 30 minutes/day of conventional physiotherapy + 30 minutes7day of verticalization using a tilt table with a robotic stepping device

OTHERconventional physiotherapy

patients are treated only with 60 minutes/day of conventional physiotherapy

Sponsors

Ospedale Generale Di Zona Moriggia-Pelascini
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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 * diabetes * cancer * alcoholism * viral hepatitis * AIDS * autoimmune diseases * absence of clinical or neurophysiological informations at data collection

Design outcomes

Primary

MeasureTime frameDescription
CIP occurrenceat enrollmentPresence of critical illness polyneuropathy at the end of ICU stay

Secondary

MeasureTime frameDescription
motricity indexat enrollmenttotal 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 enrollmentFunctional Ambulation Classification score at neurorehabilitation discharge. Scale goes from 0 (no ambulation) to 5 (independent ambulation)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026