Evidence map›Paper›PMID 30409170›Full record

ArticleTrials2018

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

Christian Gunge Riberholt, Jane Lindschou, Christian Gluud, Jesper Mehlsen, Kirsten Møller

2 registry-linked trialsOpen access · goldAbstract readClinical Trial ProtocolComparative Study
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.3field-weighted citation impact, top 19% 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.

NCT02924649 naunknown statusnot on this map

Early Mobilisation by Head-up Tilt With Stepping Compared With Standard Care After Severe Traumatic Brain Injury - a Randomised Clinical Feasibility Trial

TypeinterventionalSponsorRigshospitalet, DenmarkRan2017 to 2020Enrolled38ConditionsBrain InjuriesArmsEarly Intensive mobilisation
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
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 14 citations in OpenAlex.

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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

5 authors at 2 institutions in 1 country.

Christian Gunge RiberholtDepartment of Neurorehabilitation/TBI unit, Rigshospitalet, University of Copenhagen, Kettegard Alle 30, 2650, Hvidovre, Denmark. christian.riberholt@regionh.dk.ORCID http://orcid.org/0000-0002-6170-1869
Jane LindschouCopenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.
Christian GluudCopenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.
Jesper MehlsenSyncope Centre, Department of Cardiology, Bispebjerg & Frederiksberg Hospital, University of Copenhagen, Nordre Fasanvej 57, 2000, Frederiksberg, Denmark.
Kirsten MøllerDepartment of Neuroanaesthesiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, København Ø, Denmark.
University of Copenhagen · DKCopenhagen University Hospital · DK

Funding

Danske Fysioterapeuter 15242Rigshospitalet R114-A4672The council of the Danish Victims Fund 16-910-00043
6 · The paper itself

Abstract

backgroundIntensive 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.

methodsThis 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 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 registrationClinicalTrials.gov identifier: NCT02924649 . Registered on 3 October 2016.

Indexed as

Early AmbulationRandomized Controlled Trials as TopicBrain Injuries, TraumaticCerebrovascular CirculationFeasibility StudiesHomeostasisHumansResearch DesignBrain injuryCerebral autoregulation of blood flowRandomised feasibility trialRehabilitationTilt-table therapy

Identifiers

PMID30409170
PMCPMC6225708
OpenAlexW2899926066

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.