Effects of Early Stepping Verticalization + FES on CIP

Acquired Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03616314
• Other study ID #: Erigo/FES critical illness
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: July 1, 2018

Study information

• Verified date: August 2018
• Source: Ospedale Generale Di Zona Moriggia-Pelascini
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Critical Illness
• Critical Illness Polyneuropathy
• Polyneuropathies

Intervention

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

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

Locations

Country	Name	City	State
Italy	Ospedale Generale di Zona Moriggia Pelascini	Gravedona	CO

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Generale Di Zona Moriggia-Pelascini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CIP occurrence	Presence of critical illness polyneuropathy at the end of ICU stay	at enrollment
Secondary	motricity index	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
Secondary	Functional Ambulation Classification (FAC)	Functional Ambulation Classification score at neurorehabilitation discharge. Scale goes from 0 (no ambulation) to 5 (independent ambulation)	at enrollment