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.
journal_name
Trialsjournal_title
Trialsauthors
Riberholt CG,Lindschou J,Gluud C,Mehlsen J,Møller Kdoi
10.1186/s13063-018-3004-xsubject
Has Abstractpub_date
2018-11-08 00:00:00pages
612issue
1issn
1745-6215pii
10.1186/s13063-018-3004-xjournal_volume
19pub_type
杂志文章相关文献
Trials文献大全abstract:BACKGROUND:This update outlines changes to the MObile Technology for Improved Family Planning study statistical analysis plan and plans for long-term follow-up. These changes result from obtaining additional funding and the decision to restrict the primary analysis to participants with available follow-up data. The cha...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-440
更新日期:2014-11-12 00:00:00
abstract:BACKGROUND:Atopic dermatitis (AD) is associated with reduced skin microbial diversity and overgrowth of Staphylococcus (S.) aureus. However, the importance of S. aureus colonisation in the complex pathogenesis remains unclear and studies on the effect of anti-staphylococcal therapy in non-infected AD show contradictory...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-017-2118-x
更新日期:2017-08-31 00:00:00
abstract:BACKGROUND:Depression is one of the most common reasons for consulting in primary care. Acupuncture is a popular complementary therapy choice for depression but its evidence base is poor with more robust high quality trials being required. More than half of depressed patients experience painful symptoms, with severe pa...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-10-3
更新日期:2009-01-09 00:00:00
abstract:BACKGROUND:Tracheal intubation with the patient in the lateral position is difficult because the laryngeal view is compromised during direct laryngoscopy. Flexible video endoscopes may facilitate intubation even when laryngeal views are poor on direct laryngoscopy because the patients are positioned laterally. Thus, th...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3263-1
更新日期:2019-03-15 00:00:00
abstract:BACKGROUND:Patients can struggle to make sense of trials in emergency situations. This study examines patient experience of participating in the United Kingdom, Wound management of Open Lower Limb Fractures (UK WOLLF) study, a trial of standard wound management versus Negative Pressure Wound Therapy (NPWT). METHODS:Th...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-018-2722-4
更新日期:2018-06-25 00:00:00
abstract:BACKGROUND:Worldwide, prevalence rates of adolescent non-suicidal self-injury (NSSI) range between 13 and 45%. In Germany, lifetime prevalence of NSSI is around 25% in non-clinical samples, and the one-year prevalence for repetitive NSSI is 4%. NSSI is present in the context of several axis I and II disorders (for exam...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-294
更新日期:2013-09-13 00:00:00
abstract:BACKGROUND:Eyes sustaining open globe trauma are at high risk of severe visual impairment. Ocular injuries which result in visual loss invariably affect the posterior segment of the eye, and prevention of visual loss involves posterior segment (vitreoretinal) surgery. Despite improvements in vitreoretinal surgical tech...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-016-1445-7
更新日期:2016-07-22 00:00:00
abstract:BACKGROUND:Smoking in pregnancy is a major international public health problem. Self-help support (SHS) increases the likelihood of women stopping smoking in pregnancy and delivering this kind of support by text message could be a cost-effective way to deliver SHS to pregnant women who smoke. SHS delivered by text mess...
journal_title:Trials
pub_type: 杂志文章,meta分析,多中心研究
doi:10.1186/s13063-019-3341-4
更新日期:2019-05-22 00:00:00
abstract:BACKGROUND:The preliminary results of a randomised controlled trial are presented. The aim of the trial is to determine the efficacy, feasibility and acceptability of email-delivered psychological interventions with telephone support, for adults injured in a motor vehicle crash engaged in seeking compensation. The prim...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-018-2716-2
更新日期:2018-06-27 00:00:00
abstract:BACKGROUND:Osteoporosis-related fractures are a significant public health concern. Interventions that increase detection and treatment of osteoporosis, as well as prevention of fractures and falls, are substantially underutilized. This paper outlines the protocol for a pragmatic randomised trial of a multifaceted commu...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-9-62
更新日期:2008-11-04 00:00:00
abstract:BACKGROUND:Acute kidney allograft rejection is a major cause for declining graft function and has a negative impact on the long-term graft survival. The majority (90%) of acute rejections are T-cell mediated and, therefore, the anti-rejection therapy targets T-cell-mediated mechanisms of the rejection process. However,...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-13-199
更新日期:2012-10-26 00:00:00
abstract:BACKGROUND:Depression and bipolar disorder are associated with reduced neural plasticity and deficits in memory, attention and executive function. Drug treatments for these affective disorders have insufficient clinical effects in a large group and fail to reverse cognitive deficits. There is thus a need for more effec...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-11-97
更新日期:2010-10-13 00:00:00
abstract:BACKGROUND:Depression is common in residents of Residential and Nursing homes (RNHs). It is usually undetected and often undertreated. Depression is associated with poor outcomes including increased morbidity and mortality. Exercise has potential to improve depression, and has been shown in existing trials to improve o...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-12-27
更新日期:2011-02-02 00:00:00
abstract:BACKGROUND:During clinical trials in emergency medicine, providing appropriate oral and written information to a patient is usually a challenge. There is little published information regarding patients' opinions and competence to provide informed consent, nor on physicians' attitudes towards the process. We have invest...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-9-45
更新日期:2008-07-21 00:00:00
abstract:BACKGROUND:There is a strong evidence base for the benefits of parenting interventions for parents without severe mental illness (SMI). As the impact of maternal SMI can be significant on child development, mothers need support to maximise outcomes for themselves and their children. Some mothers with SMI require admiss...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2869-z
更新日期:2018-09-10 00:00:00
abstract:BACKGROUND:Delirium is a state of confusion characterized by an acute and fluctuating decline in cognitive functioning. Delirium is common and deadly in older adults with dementia, and is often referred to as delirium superimposed on dementia, or DSD. Interventions that treat DSD are not well-developed because the mech...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-12-119
更新日期:2011-05-11 00:00:00
abstract:BACKGROUND:Diabetic distal symmetric polyneuropathy (DSPN) is one of the most common microvascular complications of diabetes mellitus, and it has become a major public health problem worldwide because of its high and increasing prevalence, morbidity, and disability rate. The current medications for DSPN are not entirel...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-017-2345-1
更新日期:2017-12-29 00:00:00
abstract:BACKGROUND:The effects of restrictive fluid therapy combined with controlled hypotension in the elderly on systemic oxygen metabolism and renal function are clinical concerns. The aim of this study was to evaluate blood loss, oxygen metabolism, and renal function in different levels of controlled hypotension induced by...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-05015-5
更新日期:2021-01-28 00:00:00
abstract:BACKGROUND:Cardiac surgery has been shown to result in a significant decrease of the antioxidant selenium, which is associated with the development of multiorgan dysfunction and increased mortality. Thus, a large-scale study is needed to investigate the effect of perioperative selenium supplementation on the occurrence...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-15-339
更新日期:2014-08-28 00:00:00
abstract::There is a critical need for objective data to guide effective health promotion and care for homeless populations. However, many investigators exclude homeless populations from clinical trials due to practical concerns about conducting research with this population. This report is based on our experience and lessons l...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-017-2046-9
更新日期:2017-07-05 00:00:00
abstract:BACKGROUND:Traumatic brain injury (TBI) is often associated with life-long medical, cognitive, emotional, and behavioral changes. Although long-lasting disabilities are expected, research on effective treatment options in the chronic phase of TBI is scarce. METHODS/DESIGN:This study protocol describes a randomized con...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-4195-5
更新日期:2020-03-27 00:00:00
abstract:BACKGROUND:Radical cystectomy for bladder cancer is associated with a high risk of needing red blood cell transfusion. Tranexamic acid reduces blood loss during cardiac and orthopedic surgery, but no study has yet evaluated tranexamic acid use during cystectomy. METHODS:A randomized, double-blind (surgeon-, anesthesio...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2626-3
更新日期:2018-05-02 00:00:00
abstract:BACKGROUND:The World Health Organization recommended (in 2010) universal testing for suspected malaria, due to some fundamental changes in malaria trends such as the declining incidence of malaria in high-burden countries, the emergence of parasite resistance to anti-malarial drugs especially artemisinin-based combinat...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3620-0
更新日期:2019-10-10 00:00:00
abstract:BACKGROUND:The key aim of the study is to establish an agreed standardised core outcome set (COS) for use when evaluating non-pharmacological health and social care interventions for people living at home with dementia. METHODS/DESIGN:Drawing on the guidance and approaches of the Core Outcome Measures in Effectiveness...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2584-9
更新日期:2018-04-24 00:00:00
abstract:BACKGROUND:This study is a part of a series of two clinical trials. We consider diabetic polyneuropathy (DPN), a common chronic and progressive complication of diabetes mellitus that has several impacts on individuals' foot health and quality of life. Based on the current trends of self-monitoring and self-care, provid...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-4115-8
更新日期:2020-02-13 00:00:00
abstract:BACKGROUND:An individualized treatment algorithm (Copenhagen Achilles Rupture Treatment Algorithm (CARTA)) based on the ultrasonographic appearance of an acute Achilles tendon rupture has been developed aiming to select the correct patients for operative and non-operative treatment. The objective of this study is to in...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-020-04332-z
更新日期:2020-05-12 00:00:00
abstract:BACKGROUND:Bone graft substitutes are widely used for reconstruction of posttraumatic bone defects. However, their clinical significance in comparison to autologous bone grafting, the gold-standard in reconstruction of larger bone defects, still remains under debate. This prospective, randomized, controlled clinical st...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-15-75
更新日期:2014-03-08 00:00:00
abstract:OBJECTIVES:To assess the impact of adding statin (atorvastatin) and/or aspirin on clinical deterioration in patients infected with SARS-CoV-2 who require hospitalisation. The safety of these drugs in COVID-19 patients will also be evaluated. TRIAL DESIGN:This is a single-centre, prospective, four-arm parallel design, ...
journal_title:Trials
pub_type: 信件
doi:10.1186/s13063-020-04840-y
更新日期:2020-10-30 00:00:00
abstract:BACKGROUND:Idiopathic sudden sensorineural hearing loss (ISSNHL) is a major cause of deafness. Despite the advances in systemic therapy, some cases of ISSNHL are untreated, because the exact ISSNHL aetiology is unclear. Traditional Chinese medicine (TCM) has been used to treat diseases for thousands of years and is pop...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3733-5
更新日期:2019-12-02 00:00:00
abstract:BACKGROUND:Rehabilitation after spinal cord injury (SCI) has traditionally involved teaching compensatory strategies for identified impairments and deficits in order to improve functional independence. There is some evidence that regular and intensive activity-based therapies, directed at activation of the paralyzed ex...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-14-291
更新日期:2013-09-11 00:00:00