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

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

Getting the Best Out of Advanced Rehabilitation Technology for the Lower Limbs: Minding Motor Learning Principles

“…Nevertheless, a small number of studies have investigated the effect of advanced technology training on consciousness in this population. The majority of these studies investigated the effect of advanced robotic tilt tables and found a positive effect on consciousness and cognition [11,15]. The effect of robotic gait training on consciousness has not been studied as intensively.…”

Randomization Test: An Alternative Analysis for the Difference of Two Means

“…In their article, the study authors used a nonparametric Mann‐Whitney U test (also known as the Wilcoxon rank‐sum test) to compare the improvements in treatment and control groups [7]. With this test, they found a nonsignificant difference between the 2 groups with a P value of .058, which is larger than the P value obtained with the randomization test.…”

“…Box plot of original data from Frazzitta et al [7]. Note that values are computed here so that positive scores indicate a decrease (improvement) in disability between baseline and discharge from the intensive care unit.…”

“…Consider this data example to illustrate a randomization test of 2 samples for a continuous measure: Frazzitta et al [7] reported on a study in which patients in the intensive care unit (ICU) with severe acquired brain injury were randomized either to conventional physiotherapy or to an early stepped verticalization protocol. Researchers collected Disability Rating Scale (DRS) scores at 3 time points (baseline, discharge from ICU, and discharge from rehabilitation) for 15 patients in the treatment group and 16 patients in the control group.…”

Comparison between Erigo tilt-table exercise and conventional physiotherapy exercises in acute stroke patients: a randomized trial

“…Blood pressures and heart rate can be stabilized better with treatment with passive leg movements [8]. Moreover, an intensive cyclic leg loading verticalization protocol, started in the acute stages of a severe acquired brain injury, improves the short-term and long-term functional and neurological outcome of patients with disorder of consciousness [9].…”