TY - JOUR
T1 - Early Orthostatic Exercise by Head-Up Tilt With Stepping vs. Standard Care After Severe Traumatic Brain Injury Is Feasible
AU - Riberholt, Christian Gunge
AU - Olsen, Markus Harboe
AU - Søndergaard, Christian Baastrup
AU - Gluud, Christian
AU - Ovesen, Christian
AU - Jakobsen, Janus Christian
AU - Mehlsen, Jesper
AU - Møller, Kirsten
N1 - Funding Information:
The trial has been funded by The Council of Danish Victims Fund (grant 16–910-00043), by the Research Fund of Rigshospitalet, Copenhagen University Hospital (R114-A4672), and the Danish Physical Therapy Association (15242). The funders had no influence on the design of the trial or interpretation of the results.
Funding Information:
We would like to express our sincere gratitude to the staff at the Department of Neuroanaesthesiology and Neurointensive Care, Rigshospitalet, the Department of Intensive Care (Y13) at Glostrup Hospital, Rigshospitalet, and the Department of Neurorehabilitation, traumatic brain injury, Rigshospitalet for their help during this trial. A special thanks to Sofie Grue Ladefoged, Marie Glover, and Berit Gibbs at the Department of Physical Therapy, Rigshospitalet, for their help in the screening process and coordination of interventions. This article has been made publicly available as part of CGR's PhD dissertation (30). Funding. The trial has been funded by The Council of Danish Victims Fund (grant 16?910-00043), by the Research Fund of Rigshospitalet, Copenhagen University Hospital (R114-A4672), and the Danish Physical Therapy Association (15242). The funders had no influence on the design of the trial or interpretation of the results.
Publisher Copyright:
© Copyright © 2021 Riberholt, Olsen, Søndergaard, Gluud, Ovesen, Jakobsen, Mehlsen and Møller.
PY - 2021/4/14
Y1 - 2021/4/14
N2 - Background: Intensive rehabilitation of patients after severe traumatic brain injury aims to improve functional outcome. The effect of initiating rehabilitation in the early phase, in the form of head-up mobilization, is unclear. Objective: To assess whether early mobilization is feasible and safe in patients with traumatic brain injury admitted to a neurointensive care unit. Methods: This was a randomized parallel-group clinical trial, including patients with severe traumatic brain injury (Glasgow coma scale <11 and admission to the neurointensive care unit). The intervention consisted of daily mobilization on a tilt-table for 4 weeks. The control group received standard care. Outcomes were the number of included participants relative to all patients with traumatic brain injury who were approached for inclusion, the number of conducted mobilization sessions relative to all planned sessions, as well as adverse events and reactions. Information on clinical outcome was collected for exploratory purposes. Results: Thirty-eight participants were included (19 in each group), corresponding to 76% of all approached patients [95% confidence interval (CI) 63–86%]. In the intervention group, 74% [95% CI 52–89%] of planned sessions were carried out. There was no difference in the number of adverse events, serious adverse events, or adverse reactions between the groups. Conclusions: Early head-up mobilization is feasible in patients with severe traumatic brain injury. Larger randomized clinical trials are needed to explore potential benefits and harms of such an intervention. Clinical Trial Registration: [ClinicalTrials.gov], identifier [NCT02924649]. Registered on 3rd October 2016.
AB - Background: Intensive rehabilitation of patients after severe traumatic brain injury aims to improve functional outcome. The effect of initiating rehabilitation in the early phase, in the form of head-up mobilization, is unclear. Objective: To assess whether early mobilization is feasible and safe in patients with traumatic brain injury admitted to a neurointensive care unit. Methods: This was a randomized parallel-group clinical trial, including patients with severe traumatic brain injury (Glasgow coma scale <11 and admission to the neurointensive care unit). The intervention consisted of daily mobilization on a tilt-table for 4 weeks. The control group received standard care. Outcomes were the number of included participants relative to all patients with traumatic brain injury who were approached for inclusion, the number of conducted mobilization sessions relative to all planned sessions, as well as adverse events and reactions. Information on clinical outcome was collected for exploratory purposes. Results: Thirty-eight participants were included (19 in each group), corresponding to 76% of all approached patients [95% confidence interval (CI) 63–86%]. In the intervention group, 74% [95% CI 52–89%] of planned sessions were carried out. There was no difference in the number of adverse events, serious adverse events, or adverse reactions between the groups. Conclusions: Early head-up mobilization is feasible in patients with severe traumatic brain injury. Larger randomized clinical trials are needed to explore potential benefits and harms of such an intervention. Clinical Trial Registration: [ClinicalTrials.gov], identifier [NCT02924649]. Registered on 3rd October 2016.
KW - adverse events
KW - early mobilization
KW - feasibility trial
KW - head-up tilt
KW - traumatic brain injury
U2 - 10.3389/fneur.2021.626014
DO - 10.3389/fneur.2021.626014
M3 - Journal article
C2 - 33935935
AN - SCOPUS:85104936014
SN - 1664-2295
VL - 12
JO - Frontiers in Neurology
JF - Frontiers in Neurology
M1 - 626014
ER -