Critical Illness PolyneuropathyNCT03616314
Effects of Early Stepping Verticalization + FES on CIP
An observational study of Critical Illness Polyneuropathy and Acquired Brain Injury, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness Polyneuropathy, Acquired Brain Injury
- What is being tested?
- stepping verticalization plus functional electrical stimulation, stepping verticalization and conventional physiotherapy
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2018to 1 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients hospitalized in ICU and transferred in Neurorehab after an acute brain injury
Who may be able to join
- arriving directly from our acute care facility
- hospitalized in ICU due to an acute brain injury
Who cannot join
- previous peripheral neuropathies
- diabetes
- cancer
- alcoholism
- viral hepatitis
- AIDS
- autoimmune diseases
- absence of clinical or neurophysiological informations at data collection
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- stepping verticalization plus functional electrical stimulation, stepping verticalization, conventional physiotherapy
- Medical subject headings
- Polyneuropathies, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stepping verticalization plus functional electrical stimulationDevice
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 verticalizationDevice
patients receive 30 minutes/day of conventional physiotherapy + 30 minutes7day of verticalization using a tilt table with a robotic stepping device
conventional physiotherapyOther
patients are treated only with 60 minutes/day of conventional physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| stepping verticalization | in ICU they received conventional physiotherapy + stepping verticalization sessions with Erigo Receives: Device: stepping verticalization | |
| stepping verticalization + FES | in ICU they received conventional physiotherapy + stepping verticalization sessions with FES using ErigoPro Receives: Device: stepping verticalization plus functional electrical stimulation | |
| conventional physiotherapy | in ICU they received only conventional physiotherapy Receives: Other: conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CIP occurrence
Presence of critical illness polyneuropathy at the end of ICU stay
Measured: at enrollment
Secondary outcomes (2)
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)
Measured: at enrollment
Functional Ambulation Classification (FAC)
Functional Ambulation Classification score at neurorehabilitation discharge. Scale goes from 0 (no ambulation) to 5 (independent ambulation)
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Jun 2018
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Illness PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616314
- Sponsor's protocol ID
- Erigo/FES critical illness
- Status last verified
- Aug 2018
- First submitted
- 31 Jul 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03616314
- Acronym / sponsor ID
- Erigo/FES critical illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| stepping verticalization | – | Device: stepping verticalizationin ICU they received conventional physiotherapy + stepping verticalization sessions with Erigo |
| stepping verticalization + FES | – | Device: stepping verticalization plus functional electrical stimulationin ICU they received conventional physiotherapy + stepping verticalization sessions with FES using ErigoPro |
| conventional physiotherapy | – | Other: conventional physiotherapyin ICU they received only conventional physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized in ICU and transferred in Neurorehab after an acute brain injury
Key inclusion criteria (2 listed)
- arriving directly from our acute care facility
- hospitalized in ICU due to an acute brain injury
Key exclusion criteria (8 listed)
- previous peripheral neuropathies
- diabetes
- cancer
- alcoholism
- viral hepatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stepping verticalization plus functional electrical stimulationpatients 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 | Device | stepping verticalization + FES |
| stepping verticalizationpatients receive 30 minutes/day of conventional physiotherapy + 30 minutes7day of verticalization using a tilt table with a robotic stepping device | Device | stepping verticalization |
| conventional physiotherapypatients are treated only with 60 minutes/day of conventional physiotherapy | Other | conventional physiotherapy |
Primary outcome
CIP occurrence
Time frame: at enrollment
Presence of critical illness polyneuropathy at the end of ICU stay
2 secondary outcomes
motricity index
Time frame: at enrollment
Functional Ambulation Classification (FAC)
Time frame: at enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness Polyneuropathy and Acquired Brain Injury, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIP occurrence (time frame: at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.