Study Results
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Basic Information
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COMPLETED
39 participants
OBSERVATIONAL
2018-06-01
2018-07-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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stepping verticalization
in ICU they received conventional physiotherapy + stepping verticalization sessions with Erigo
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
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
conventional physiotherapy
patients are treated only with 60 minutes/day of conventional physiotherapy
Interventions
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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
conventional physiotherapy
patients are treated only with 60 minutes/day of conventional physiotherapy
Eligibility Criteria
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Inclusion Criteria
* hospitalized in ICU due to an acute brain injury
Exclusion Criteria
* diabetes
* cancer
* alcoholism
* viral hepatitis
* AIDS
* autoimmune diseases
* absence of clinical or neurophysiological informations at data collection
18 Years
ALL
No
Sponsors
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Ospedale Generale Di Zona Moriggia-Pelascini
OTHER
Responsible Party
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Locations
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Ospedale Generale di Zona Moriggia Pelascini
Gravedona, CO, Italy
Countries
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Other Identifiers
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Erigo/FES critical illness
Identifier Type: -
Identifier Source: org_study_id
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