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Effects of Early Stepping Verticalization + FES on CIP

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ClinicalTrials.gov Identifier: NCT03616314
Recruitment Status : Completed
First Posted : August 6, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ospedale Generale Di Zona Moriggia-Pelascini

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.


Condition or disease Intervention/treatment
Critical Illness Polyneuropathy Acquired Brain Injury Device: stepping verticalization plus functional electrical stimulation Device: stepping verticalization Other: conventional physiotherapy

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Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 1, 2018

Group/Cohort Intervention/treatment
stepping verticalization
in ICU they received conventional physiotherapy + stepping verticalization sessions with Erigo
Device: stepping verticalization
patients receive 30 minutes/day of conventional physiotherapy + 30 minutes7day of verticalization using a tilt table with a robotic stepping device

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

conventional physiotherapy
in ICU they received only conventional physiotherapy
Other: conventional physiotherapy
patients are treated only with 60 minutes/day of conventional physiotherapy




Primary Outcome Measures :
  1. CIP occurrence [ Time Frame: at enrollment ]
    Presence of critical illness polyneuropathy at the end of ICU stay


Secondary Outcome Measures :
  1. motricity index [ Time Frame: at enrollment ]
    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)

  2. Functional Ambulation Classification (FAC) [ Time Frame: at enrollment ]
    Functional Ambulation Classification score at neurorehabilitation discharge. Scale goes from 0 (no ambulation) to 5 (independent ambulation)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients hospitalized in ICU and transferred in Neurorehab after an acute brain injury
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616314


Locations
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Italy
Ospedale Generale di Zona Moriggia Pelascini
Gravedona, CO, Italy, 22015
Sponsors and Collaborators
Ospedale Generale Di Zona Moriggia-Pelascini
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Responsible Party: Ospedale Generale Di Zona Moriggia-Pelascini
ClinicalTrials.gov Identifier: NCT03616314    
Other Study ID Numbers: Erigo/FES critical illness
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Polyneuropathies
Critical Illness
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Disease Attributes
Pathologic Processes
Peripheral Nervous System Diseases
Neuromuscular Diseases