OBJECTIVES: We assessed the effectiveness of frequent higher dose very early mobilisation (VEM) after stroke.
DESIGN: We conducted a parallel-group, single-blind, prospective randomised controlled trial with blinded end-point assessment using a web-based computer-generated stratified randomisation.
SETTING: The trial took place in 56 acute stroke units in five countries.
PARTICIPANTS: We included adult patients with a first or recurrent stroke who met physiological inclusion criteria.
INTERVENTIONS: Patients received either usual stroke unit care (UC) or UC plus VEM commencing within 24 hours of stroke.
MAIN OUTCOME MEASURES: The primary outcome was good recovery [modified Rankin scale (mRS) score of 0-2] 3 months after stroke. Secondary outcomes at 3 months were the mRS, time to achieve walking 50 m, serious adverse events, quality of life (QoL) and costs at 12 months. Tertiary outcomes included a dose-response analysis.
DATA SOURCES: Patients, outcome assessors and investigators involved in the trial were blinded to treatment allocation.
RESULTS: We recruited 2104 (UK, n = 610; Australasia, n = 1494) patients: 1054 allocated to VEM and 1050 to UC. Intervention protocol targets were achieved. Compared with UC, VEM patients mobilised 4.8 hours [95% confidence interval (CI) 4.1 to 5.7 hours; p stroke may be associated with a more favourable outcome.
FUTURE WORK: These results informed a new trial proposal [A Very Early Rehabilitation Trial - DOSE (AVERT-DOSE)] aiming to determine the optimal frequency and dose of EM.
TRIAL REGISTRATION: The trial is registered with the Australian New Zealand Clinical Trials Registry number ACTRN12606000185561, Current Controlled Trials ISRCTN98129255 and ISRCTN98129255.
FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 54. See the NIHR Journals Library website for further project information. Funding was also received from the National Health and Medical Research Council Australia, Singapore Health, Chest Heart and Stroke Scotland, Northern Ireland Chest Heart and Stroke, and the Stroke Association. In addition, National Health and Medical Research Council fellowship funding was provided to Julie Bernhardt (1058635), who also received fellowship funding from the Australia Research Council (0991086) and the National Heart Foundation (G04M1571). The Florey Institute of Neuroscience and Mental Health, which hosted the trial, acknowledges the support received from the Victorian Government via the Operational Infrastructure Support Scheme.
DESIGN: Retrospective observational analysis.
SETTING: 56 acute stroke hospitals in eight countries.
PARTICIPANTS: 1074 trial physiotherapists, nurses, and other clinicians.
OUTCOME MEASURES: Number of babies born during trial recruitment per trial participant recruited.
RESULTS: With 198 site recruitment years and 2104 patients recruited during AVERT, 120 babies were born to trial staff. Births led to an estimated 10% loss in time to achieve recruitment. Parental leave was linked to six trial site closures. The number of participants needed to recruit per baby born was 17.5 (95% confidence interval 14.7 to 21.0); additional trial costs associated with each birth were estimated at 5736 Australian dollars on average.
CONCLUSION: The staff absences registered in AVERT owing to parental leave led to delayed trial recruitment and increased costs, and should be considered by trial investigators when planning research and estimating budgets. However, the celebration of new life became a highlight of the annual AVERT collaborators' meetings and helped maintain a cohesive collaborative group.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry no 12606000185561.
DISCLAIMER: Participation in a rehabilitation trial does not guarantee successful reproductive activity.
FINDINGS AND CONCLUSIONS: Stroke recovery involves adapting to new limitations and discovering the support necessary to live life. These changes are influenced by a range of environmental factors. Healthcare professionals need to support stroke patients in identifying challenges and work to find innovative ways to address them. Stroke survivors may benefit from the use of an assistive device beyond its clinical function to participate purposefully in activities of daily living. Implications for Rehabilitation Stroke is a cause of disability that limits everyday activities and reduces social participation. Assistive devices help achieve independence, social inclusion and shape stroke recovery. Individuals with disabilities in low and middle income countries often do not have access to assistive devices and resort to innovative solutions that are purpose built. Stroke recovery involves adapting to new limitations and discovering the support necessary to live life as best as possible.
Objectives: This pilot study compared the motor evoked potential (MEP) changes using different settings of rTMS in the post-ischemic stroke patient. The goal of the study is to identify effect sizes for a further trial and evaluate safety aspects.
Methods: Eight post-stroke patients with upper limb hemiparesis for at least six months duration were studied in a tertiary hospital in Northeast Malaysia. Quasi experimental design was applied and the participants were randomised into two groups using software generated random numbers. One of the two settings: i) inhibitory setting, or ii) facilitatory setting have been applied randomly during the first meeting. The motor evoked potential (MEP) were recorded before and after application of the rTMS setting. A week later, a similar procedure will be repeated but using different setting than the first intervention. Each patient will serve as their own control. Repeated measures ANOVA test was applied to determine the effect sizes for both intervention through the options of partial eta-squared (η2p).
Result: The study observed large effect sizes (η2p > 0.14) for both rTMS settings in the lesion and non-lesion sides. For safety aspects, no minor or major side effects associated with the rTMS was reported by the participants.
Conclusions: The partial eta square of MEP value for both rTMS settings (fascilitatory and inhibitory) in both lesion and non-lesion sides represents large effect sizes. We recommend further trial to increase number of sample in order to study the effectiveness of both settings in ischemic stroke patient. Our preliminary data showed both settings may improve the MEP of the upper extremity in the ischemic stroke patient. No significant improvement noted when comparing both settings.
OBJECTIVES: This paper presents consensus work conducted with an international group of expert stroke recovery and rehabilitation researchers, clinicians, and people living with stroke to identify and define criteria and measurable indicators for Centers of Clinical Excellence (CoCE) in stroke recovery and rehabilitation. These were intentionally developed to be ambitious and internationally relevant, regardless of a country's development or income status, to drive global improvement in stroke services.
METHODS: Criteria and specific measurable indicators for CoCE were collaboratively developed by an international panel of stroke recovery and rehabilitation experts from 10 countries and consumer groups from 5 countries.
RESULTS: The criteria and associated indicators, ranked in order of importance, focused upon (i) optimal outcome, (ii) research culture, (iii) working collaboratively with people living with stroke, (iv) knowledge exchange, (v) leadership, (vi) education, and (vii) advocacy. Work is currently underway to user-test the criteria and indicators in 14 rehabilitation centers in 10 different countries.
CONCLUSIONS: We anticipate that use of the criteria and indicators could support individual organizations to further develop their services and, more widely, provide a mechanism by which clinical excellence can be articulated and shared to generate global improvements in stroke care.
METHODS: A systematic literature review on economic studies reporting PSC-associated data was performed in PubMed/MEDLINE, Scopus/Elsevier and Cochrane databases, Google Scholar and gray literature ranging from January 2000 to August 2016. Results for post-stroke interventions (treatment and care) were systematically extracted and summarized in evidence tables reporting study characteristics and economic outcomes. Economic results were converted to 2015 US Dollars, and the total cost of PSC per patient month (PM) was calculated.
RESULTS: We included 42 studies. Overall PSC costs (inpatient/outpatient) were highest in the USA ($4850/PM) and lowest in Australia ($752/PM). Studies assessing only outpatient care reported the highest cost in the United Kingdom ($883/PM), and the lowest in Malaysia ($192/PM). Fifteen different segments of specific services utilization were described, in which rehabilitation and nursing care were identified as the major contributors.
CONCLUSION: The highest PSC costs were observed in the USA, with rehabilitation services being the main cost driver. Due to diversity in reporting, it was not possible to conduct a detailed cost analysis addressing different segments of services. Further approaches should benefit from the advantages of administrative and claims data, focusing on inpatient/outpatient PSC cost and its predictors, assuring appropriate resource allocation.