Brain InjuryNCT02828371

Early Stepping Verticalization in ICU for ABI Patients

A study testing stepping verticalization and conventional mobilization in people with Brain Injury and Consciousness Disorders, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Verticalization was reported to improve the level of arousal and awareness in patients with severe acquired brain injury (ABI) and to be safe in ICU. The investigators evaluated the effectiveness of a very early stepping verticalization protocol on the functional and neurological outcome of patients affected by… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Brain Injury, Consciousness Disorders
What is being tested?: stepping verticalization and conventional mobilization
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteItaly
Study dates: Jan 2015to Dec 2015
Phase: Interventional
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

Who may be able to join

Glasgow Coma Scale (GCS) ≤8 for ≥24h from the event;
diagnosis of vegetative state or minimally conscious state on the third day after the injury;
adequate pulmonary gas exchanging function;
stable hemodynamics

Who cannot join

sedation;
unstable intracranial pressure (ICP);
cerebral perfusion pressure (CPP) <60 mmHg;
fractures or skin lesions in thorax, abdomen or lower limbs;
deep vein thrombosis;
body weight >130 kg; height >210 cm.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Ospedale Generale di Zona "Moriggia Pelascini"
Gravedona Ed Uniti, CO, 22015

Other trials in Italy

About this study

Official title: Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: a Randomized Pilot Study in ICU

Consecutive patients with Vegetative State or Minimally Conscious State were enrolled in ICU on the third day after an ABI. They were randomized to undergo conventional physiotherapy alone or associated to fifteen 30-minute sessions of verticalization, using a tilt table with robotic stepping device. Once stabilized, patients were transferred to a Neurorehabilitation unit for an individualized treatment. Outcome measures were assessed on the third day from the injury (T0), at ICU discharge (T1) and at Rehab discharge (T2).

Conditions: Brain Injury, Consciousness Disorders
Being tested: stepping verticalization, conventional mobilization
Medical subject headings: Brain Injuries, Consciousness Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

stepping verticalizationDevice
After patient positioning, the slope of the tilt table was gradually increased from 0° to 20°, 40° and then 60° in a time span of nine minutes. The stepping frequency was set at 20 steps/min for the entire treatment. Cardiovascular and respiratory parameters were continuously monitored. The net time of the session was 30 minutes
conventional mobilizationOther
in-bed physiotherapy (mobilization exercises in supine and sitting position on bed, without out-of-bed mobilization nor verticalization)

Study groups in NCT02828371
Study group	Role	What they receive
Erigo	Experimental	Single daily sessions of verticalization, using a tilt table with an integrated robotic stepping device (Erigo. Hocoma AG, Switzerland) located in the ICU room. Sessions were performed five times per week (Monday-Friday) for three consecutive weeks (a total of 15 sessions per patient). On the same days the patients received conventional physiotherapy for 30 minutes a day. Before the verticalization period the experimental group received conventional in-bed physiotherapy for 60 minutes a day. Receives: Device: stepping verticalization
Conventional	Active comparator	treated with conventional in-bed physiotherapy for 60 minutes a day, from Monday to Friday, throughout the ICU stay. Receives: Other: conventional mobilization

What is being measured

The primary outcome is the main question the study is designed to answer.

Coma Recovery Scale change
Measured: through study completion, average 18 weeks
Glasgow Coma Scale change
Measured: through study completion, average 18 weeks
Levels of Cognitive Functioning change
Measured: through study completion, average 18 weeks
Disability Rating Scale change
Measured: through study completion, average 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Dec 2015

First posted11 Jul 2016 (estimated)
Study startJan 2015
Primary completionNov 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Brain InjuryStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02828371
Sponsor's protocol ID: Erigo_eff
Status last verified: Jul 2016
First submitted: 2 Jul 2016
Last updated: 11 Jul 2016
Results posted: No

Publications

Frazzitta G, Zivi I, Valsecchi R, Bonini S, Maffia S, Molatore K, Sebastianelli L, Zarucchi A, Matteri D, Ercoli G, Maestri R, Saltuari L. Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: A Randomized Pilot Study in ICU. PLoS One. 2016 Jul 22;11(7):e0158030. doi: 10.1371/journal.pone.0158030. eCollection 2016.
PubMed 27447483

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: a Randomized Pilot Study in ICU
ClinicalTrials.gov ID: NCT02828371
Acronym / sponsor ID: Erigo_eff
Conditions: Brain Injury, Consciousness Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
Study start: Jan 2015
Primary completion: Nov 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 11 Jul 2016 (estimated)
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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Erigo	Experimental	Device: stepping verticalizationSingle daily sessions of verticalization, using a tilt table with an integrated robotic stepping device (Erigo. Hocoma AG, Switzerland) located in the ICU room. Sessions were performed five times per week (Monday-Friday) for three consecutive weeks (a total of 15 sessions per patient). On the same days the patients received conventional physiotherapy for 30 minutes a day. Before the verticalization period the experimental group received conventional in-bed physiotherapy for 60 minutes a day.
Conventional	Active comparator	Other: conventional mobilizationtreated with conventional in-bed physiotherapy for 60 minutes a day, from Monday to Friday, throughout the ICU stay.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Glasgow Coma Scale (GCS) ≤8 for ≥24h from the event;
diagnosis of vegetative state or minimally conscious state on the third day after the injury;
adequate pulmonary gas exchanging function;
stable hemodynamics

Key exclusion criteria (6 listed)

sedation;
unstable intracranial pressure (ICP);
cerebral perfusion pressure (CPP) <60 mmHg;
fractures or skin lesions in thorax, abdomen or lower limbs;
deep vein thrombosis;

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 verticalizationAfter patient positioning, the slope of the tilt table was gradually increased from 0° to 20°, 40° and then 60° in a time span of nine minutes. The stepping frequency was set at 20 steps/min for the entire treatment. Cardiovascular and respiratory parameters were continuously monitored. The net time of the session was 30 minutes	Device	Erigo
conventional mobilizationin-bed physiotherapy (mobilization exercises in supine and sitting position on bed, without out-of-bed mobilization nor verticalization)	Other	Conventional

Primary outcome

Coma Recovery Scale change
Time frame: through study completion, average 18 weeks
Glasgow Coma Scale change
Time frame: through study completion, average 18 weeks
Levels of Cognitive Functioning change
Time frame: through study completion, average 18 weeks
Disability Rating Scale change
Time frame: through study completion, average 18 weeks

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 11 Jul 2016.
Derived from this study: PubMed 27447483Frazzitta G, Zivi I, Valsecchi R, Bonini S, Maffia S, Molatore K, Sebastianelli L, Zarucchi A, Matteri D, Ercoli G, Maestri R, Saltuari L. Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: A Randomized Pilot Study in ICU. PLoS One. 2016 Jul 22;11(7):e0158030. doi: 10.1371/journal.pone.0158030. eCollection 2016.

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Post Traumatic Stress Disorder, Traumatic Brain Injury
Recruiting
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Chronic Subdural Hematoma
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
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Not yet recruiting
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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?

A study testing stepping verticalization and conventional mobilization in people with Brain Injury and Consciousness Disorders, 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 4 inclusion and 6 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 11 Jul 2016. 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?

Coma Recovery Scale change (time frame: through study completion, average 18 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02828371, which also lists 1 linked publication.

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 11 Jul 2016.