Early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury – Protocol for a randomised clinical feasibility trial

Abstract Background Intensive rehabilitation of patients with severe traumatic brain injury is generally applied in the subacute stages of the hospital stay. Few studies have assessed the association between early and intensive physical rehabilitation and functional outcomes. The aim of this trial i...

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Main Authors: Christian Gunge Riberholt, Jane Lindschou, Christian Gluud, Jesper Mehlsen, Kirsten Møller
Format: Article
Language:English
Published: BMC 2018-11-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-018-3004-x
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spelling doaj-171fb3bc93ba4d8eab9609ed8863944c2020-11-25T02:02:27ZengBMCTrials1745-62152018-11-011911910.1186/s13063-018-3004-xEarly mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury – Protocol for a randomised clinical feasibility trialChristian Gunge Riberholt0Jane Lindschou1Christian Gluud2Jesper Mehlsen3Kirsten Møller4Department of Neurorehabilitation/TBI unit, Rigshospitalet, University of CopenhagenCopenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University HospitalCopenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University HospitalSyncope Centre, Department of Cardiology, Bispebjerg & Frederiksberg Hospital, University of CopenhagenDepartment of Neuroanaesthesiology, Rigshospitalet, University of CopenhagenAbstract Background Intensive rehabilitation of patients with severe traumatic brain injury is generally applied in the subacute stages of the hospital stay. Few studies have assessed the association between early and intensive physical rehabilitation and functional outcomes. The aim of this trial is to assess the feasibility of an intensive physical rehabilitation intervention focusing on mobilisation to the upright position, starting as early as clinically possible versus standard care in the intensive care unit. The feasibility study is intended to inform a subsequent randomised clinical trial that will investigate benefits and harms of the intervention. Methods This randomised clinical feasibility trial with a follow-up period of 1 year will use blinded outcome assessors for the Coma Recovery Scale–Revised. A maximum of 60 patients admitted to the neurointensive care unit at Rigshospitalet, Denmark, with traumatic brain injury (age of at least 18 years), a low level of consciousness, and stable intracranial pressure will be included in the trial. Patients will be randomly assigned to experimental intervention versus standard care (1:1) stratified according to their Glasgow Coma Score. The intervention group will receive daily mobilisation in a tilt table with an integrated stepping device (ERIGO®). Feasibility is declared if more than 60% (the lower 95% confidence interval of the proportion) of eligible patients are included in the trial and more than 52% (the lower 95% confidence interval of the proportion) of patients in the intervention group receive more than 60% of the planned interventions. Safety is assessed by the occurrence of adverse events and adverse reactions. Exploratory clinical outcomes consist of cerebral haemodynamics (blood flow velocity and pressure autoregulation) and baroreceptor sensitivity in the early phase as well as functional outcomes (Coma Recovery Scale–Revised, Early Functional Ability scale, and Functional Independence Measure). Discussion Our findings will inform a future, larger-scale randomised clinical trial on early mobilisation using a tilt table early after severe traumatic brain injury. Trial registration ClinicalTrials.gov identifier: NCT02924649. Registered on 3 October 2016.http://link.springer.com/article/10.1186/s13063-018-3004-xBrain injuryRandomised feasibility trialCerebral autoregulation of blood flowRehabilitationTilt-table therapy
collection DOAJ
language English
format Article
sources DOAJ
author Christian Gunge Riberholt
Jane Lindschou
Christian Gluud
Jesper Mehlsen
Kirsten Møller
spellingShingle Christian Gunge Riberholt
Jane Lindschou
Christian Gluud
Jesper Mehlsen
Kirsten Møller
Early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury – Protocol for a randomised clinical feasibility trial
Trials
Brain injury
Randomised feasibility trial
Cerebral autoregulation of blood flow
Rehabilitation
Tilt-table therapy
author_facet Christian Gunge Riberholt
Jane Lindschou
Christian Gluud
Jesper Mehlsen
Kirsten Møller
author_sort Christian Gunge Riberholt
title Early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury – Protocol for a randomised clinical feasibility trial
title_short Early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury – Protocol for a randomised clinical feasibility trial
title_full Early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury – Protocol for a randomised clinical feasibility trial
title_fullStr Early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury – Protocol for a randomised clinical feasibility trial
title_full_unstemmed Early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury – Protocol for a randomised clinical feasibility trial
title_sort early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury – protocol for a randomised clinical feasibility trial
publisher BMC
series Trials
issn 1745-6215
publishDate 2018-11-01
description Abstract Background Intensive rehabilitation of patients with severe traumatic brain injury is generally applied in the subacute stages of the hospital stay. Few studies have assessed the association between early and intensive physical rehabilitation and functional outcomes. The aim of this trial is to assess the feasibility of an intensive physical rehabilitation intervention focusing on mobilisation to the upright position, starting as early as clinically possible versus standard care in the intensive care unit. The feasibility study is intended to inform a subsequent randomised clinical trial that will investigate benefits and harms of the intervention. Methods This randomised clinical feasibility trial with a follow-up period of 1 year will use blinded outcome assessors for the Coma Recovery Scale–Revised. A maximum of 60 patients admitted to the neurointensive care unit at Rigshospitalet, Denmark, with traumatic brain injury (age of at least 18 years), a low level of consciousness, and stable intracranial pressure will be included in the trial. Patients will be randomly assigned to experimental intervention versus standard care (1:1) stratified according to their Glasgow Coma Score. The intervention group will receive daily mobilisation in a tilt table with an integrated stepping device (ERIGO®). Feasibility is declared if more than 60% (the lower 95% confidence interval of the proportion) of eligible patients are included in the trial and more than 52% (the lower 95% confidence interval of the proportion) of patients in the intervention group receive more than 60% of the planned interventions. Safety is assessed by the occurrence of adverse events and adverse reactions. Exploratory clinical outcomes consist of cerebral haemodynamics (blood flow velocity and pressure autoregulation) and baroreceptor sensitivity in the early phase as well as functional outcomes (Coma Recovery Scale–Revised, Early Functional Ability scale, and Functional Independence Measure). Discussion Our findings will inform a future, larger-scale randomised clinical trial on early mobilisation using a tilt table early after severe traumatic brain injury. Trial registration ClinicalTrials.gov identifier: NCT02924649. Registered on 3 October 2016.
topic Brain injury
Randomised feasibility trial
Cerebral autoregulation of blood flow
Rehabilitation
Tilt-table therapy
url http://link.springer.com/article/10.1186/s13063-018-3004-x
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