Effects of Early Stepping Verticalization + FES on CIP

NCT03616314 | Completed

• 1 other identifier: Erigo/FES critical illness
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness Polyneuropathy; Acquired Brain Injury

Outcome Measures

Primary Outcomes (1)

• CIP occurrence

  Presence of critical illness polyneuropathy at the end of ICU stay

  at enrollment

Secondary Outcomes (2)

• motricity index

  at enrollment

• Functional Ambulation Classification (FAC)

  at enrollment

Study Arms (3)

stepping verticalization

in ICU they received conventional physiotherapy + stepping verticalization sessions with Erigo

Device: stepping verticalization

stepping verticalization + FES

in ICU they received conventional physiotherapy + stepping verticalization sessions with FES using ErigoPro

Device: stepping verticalization plus functional electrical stimulation

conventional physiotherapy

in ICU they received only conventional physiotherapy

Other: conventional physiotherapy

Interventions

stepping verticalization plus functional electrical stimulation DEVICE

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

stepping verticalization + FES

stepping verticalization DEVICE

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

stepping verticalization

conventional physiotherapy OTHER

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

conventional physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients hospitalized in ICU and transferred in Neurorehab after an acute brain injury

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ospedale Generale Di Zona Moriggia-Pelascini: lead

Study Sites (1)

Ospedale Generale di Zona Moriggia Pelascini

Gravedona, CO, 22015, Italy

Location

MeSH Terms

Conditions

Polyneuropathies; Brain Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 6, 2018
• Study Start: June 1, 2018
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 14, 2018

Record last verified: 2018-08

Locations

IT (1)