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 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.

Keywords: Brain injury; Cerebral autoregulation of blood flow; Randomised feasibility trial; Rehabilitation; Tilt-table therapy.

Conflict of interest statement

Authors’ information

CGR is a physical therapist and PhD student at the University of Copenhagen, Faculty of Health and Medical Sciences, and is employed at the department of neurorehabilitation/TBI unit in the Research Unit on BRain Injury Copenhagen (RUBRIC). JM is a medical doctor at the Syncope Centre, Bispebjerg & Frederiksberg Hospital, Nordre Fasanvej 57, 2000 Frederiksberg, Denmark. JL is a clinical research consultant, MSc, at the Copenhagen Trial Unit, Centre for Clinical Intervention Research, Dept. 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen, Denmark. CG is a medical doctor, consultant, and head of department, DMSc, at the Copenhagen Trial Unit, Centre for Clinical Intervention Research, Blegdamsvej 9, DK-2100 Copenhagen, Denmark. KM is a medical doctor, consultant, and professor at the Department of Neuroanaesthesiology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark.

Ethics approval and consent to participate

This trial has been approved by the Scientific-Ethics Committee of the Capital Region (H-16041794) and is registered at www.clinicaltrials.gov (ClinicalTrials.gov identifier: NCT02924649). After a patient is found to be eligible for the trial, informed consent from the proxy and a trial guardian (a physician not involved in the trial) is obtained by CGR. CGR is the project manager and is responsible for collecting and storing data and all correspondence.

The trial is carried out in accordance with the principles of the Helsinki Declaration. The project manager is responsible for informing the Scientific-Ethics Committee of the Capital Region in Denmark of any critical adverse event or major changes of the protocol or both. All correspondence will be filed by the project manager.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) table of enrollment, intervention, and assessments

Fig. 2

Trial flow diagram. Abbreviations: GCS Glasgow Coma Scale, ICP intracranial pressure