Evidence map›Paper›PMID 27447483›Full record

Trial reportPloS one2016

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

Giuseppe Frazzitta, Ilaria Zivi, Roberto Valsecchi, Sara Bonini, Sara Maffia, Katia Molatore, Luca Sebastianelli, Alessio Zarucchi, Diana Matteri, Giuseppe Ercoli and 2 more

3 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 35 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 4 pooled it
4.8field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02828371 nacompletednot on this map

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

TypeinterventionalSponsorOspedale Generale Di Zona Moriggia-PelasciniRan2015 to 2015Enrolled40ConditionsBrain Injury, Consciousness DisordersArmsstepping verticalization, conventional mobilization
NCT04452019 nacompletednot on this mapstarted 2020, after this paper: background citation

Responses on Use of Standing Frame and "Innowalk Pro" in Subacute Patients With Severe Functional Deficits Due to Acquired Brain Injury.

TypeinterventionalSponsorSunnaas Rehabilitation HospitalRan2020 to 2022Enrolled18ConditionsBrain InjuriesArmsUse of standard standing frame, Use of a new device, Innowalk Pro
NCT05953649 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Effect of Early Extracorporeal Diaphragm Pacing (EDP) Combined With Tilt Table Verticalization (TTV) on Diaphragm Function in Critically Ill Patients With Mechanical Ventilation: a Randomized Controlled Trial.

TypeinterventionalSponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRan2023 to 2024Enrolled90ConditionsEarly Mobilization, Critically Ill, Mechanical Ventilation, Diaphragm DysfunctionArmsExtracorporeal Diaphragm Pacing, Tilt Table Verticalization, Conventional Physiotherapy
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 4 syntheses or guidelines pooled it, 94 citations in OpenAlex.

  1. Guideline
  2. Use of Robots in Critical Care: Systematic Review.Journal of medical Internet research · 2022
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Effect of verticalization with Erigo® in the acute rehabilitation of severe acquired brain injury.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2019
    Trial
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Mobilization in Neurocritical Care: Challenges and Opportunities.Current neurology and neuroscience reports · 2024
    Review
  15. Article
  16. Article
  17. Observational
  18. Article
  19. Inpatient Physical Therapy in Moderate to Severe Traumatic Brain Injury in in Older Adults: A Scoping Review.International journal of environmental research and public health · 2023
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 1 country.

Giuseppe FrazzittaDepartment of Brain Injury and Parkinson Disease Rehabilitation, Ospedale "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy.
Ilaria ZiviDepartment of Brain Injury and Parkinson Disease Rehabilitation, Ospedale "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy.
Roberto ValsecchiDepartment of Intensive Care, Ospedale "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy.
Sara BoniniDepartment of Brain Injury and Parkinson Disease Rehabilitation, Ospedale "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy.
Sara MaffiaDepartment of Brain Injury and Parkinson Disease Rehabilitation, Ospedale "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy.
Katia MolatoreDepartment of Brain Injury and Parkinson Disease Rehabilitation, Ospedale "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy.
Luca SebastianelliDepartment of Brain Injury and Parkinson Disease Rehabilitation, Ospedale "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy.
Alessio ZarucchiDepartment of Brain Injury and Parkinson Disease Rehabilitation, Ospedale "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy.
Diana MatteriDepartment of Brain Injury and Parkinson Disease Rehabilitation, Ospedale "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy.
Giuseppe ErcoliDepartment of Brain Injury and Parkinson Disease Rehabilitation, Ospedale "Moriggia-Pelascini", Gravedona ed Uniti (CO), Italy.
Roberto MaestriDepartment of Biomedical Engineering, Scientific Institute of Montescano, Fondazione S. Maugeri IRCCS, Montescano (PV), Italy.
Leopold SaltuariResearch Unit for Neurorehabilitation South Tyrol, Landeskrankenhaus Hochzirl-Natters, Zirl, Austria.
Moriggia Pelascini Hospital · ITFondazione Salvatore Maugeri · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveVerticalization was reported to improve the level of arousal and awareness in patients with severe acquired brain injury (ABI) and to be safe in ICU. We evaluated the effectiveness of a very early stepping verticalization protocol on their functional and neurological outcome.

methodsConsecutive 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 our Neurorehabilitation unit for an individualized treatment. Outcome measures (Glasgow Coma Scale, Coma Recovery Scale revised -CRSr-, Disability Rating Scale-DRS- and Levels of Cognitive Functioning) were assessed on the third day from the injury (T0), at ICU discharge (T1) and at Rehab discharge (T2). Between- and within-group comparisons were performed by the Mann-Whitney U test and Wilcoxon signed-rank test, respectively.

resultsOf the 40 patients enrolled, 31 completed the study without adverse events (15 in the verticalization group and 16 in the conventional physiotherapy). Early verticalization started 12.4±7.3 (mean±SD) days after ABI. The length of stay in ICU was longer for the verticalization group (38.8 ± 15.7 vs 25.1 ± 11.2 days, p = 0.01), while the total length of stay (ICU+Neurorehabilitation) was not significantly different (153.2 ± 59.6 vs 134.0 ± 61.0 days, p = 0.41). All outcome measures significantly improved in both groups after the overall period (T2 vs T0, p<0.001 all), as well as after ICU stay (T1 vs T0, p<0.004 all) and after Neurorehabilitation (T2 vs T1, p<0.004 all). The improvement was significantly better in the experimental group for CRSr (T2-T0 p = 0.033, T1-T0 p = 0.006) and (borderline) for DRS (T2-T0 p = 0.040, T1-T0 p = 0.058).

conclusionsA stepping verticalization protocol, started since the acute stages, improves the short-term and long-term functional and neurological outcome of ABI patients.

trial registrationclinicaltrials.gov NCT02828371.

Indexed as

Intensive Care UnitsPostureAgedArousalAwarenessBrain InjuriesFemaleHumansItalyMaleMiddle AgedPersistent Vegetative StateSingle-Blind Method

Identifiers

PMID27447483
PMCPMC4957764
OpenAlexW2491378668

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.