Akershus Early Mobilisation in Stroke Study (AKEMIS)
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|ClinicalTrials.gov Identifier: NCT00832351|
Recruitment Status : Completed
First Posted : January 30, 2009
Last Update Posted : January 1, 2016
Treatment in stroke units compared with treatment in general medical wards reduces the odds of being dead or disabled. Little is known about which components of acute stroke care that is responsible for this benefit.
Early mobilisation is one of the features of stroke unit care. In Scandinavia, any intervention aimed to reduce the time to the first out of bed episode has been focused in order to prevent complications.
However, therapeutic interventions for cerebral revascularisation and a more intensive unit approach for observation may postpone mobilisation. The aim of the present study is to identify whether early mobilisation (< 24 hours after admittance to hospital)reduce disability and mortality compared with mobilisation after 24 hours.
The study is a prospective, randomised controlled study with blinded assessment at the end of follow up. Patients admitted to the Stroke Unit, Akershus University Hospital less than 24 hours after stroke during 2009 - 2011 are screened for recruitment. Patients are randomly assigned to either mobilisation out of bed within 24 hours from admittance to hospital or mobilisation after 24 hours. Except early contra late mobilisation all patients receive standard stroke unit care.
Patients with modified Rankin Scale 0 and 1, patients with a secondary intracerebral hemorrhage, patients receiving thrombolysis or patients requiring palliative care are excluded.
All patients are assessed at admittance, discharge and 3 months poststroke. Investigations at admittance include standard blood sample, CT/MRI scan, EKG and ultrasound of carotid arteries.
Main outcome is mortality and disability 3 months poststroke. Secondary outcome measures are neurological deficits (NIH), morbidity, complications, cognitive function reflected by Mini Mental State Examination and emotional function (Hospital Anxiety and Depression scale) .
Results from this study may add important knowledge about how and when to start mobilisation of patients with acute stroke.
|Condition or disease||Intervention/treatment|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Immediate Mobilisation After Stroke on Mortality, Morbidity and Functional Outcome|
|Study Start Date :||March 2009|
|Primary Completion Date :||May 2010|
|Study Completion Date :||May 2010|
Early mobilisation within 24 hours after admittance to hospital
No Intervention: 2
Mobilisation after 24 but within 48 hours from admittance to hospital
- Effect of early mobilisation after stroke (< 24 hours after admittance to hospital) on mortality, morbidity and functional outcome [ Time Frame: 3 month ]
- Neurological deficits [ Time Frame: 3 month ]NIHSS
- Morbidity [ Time Frame: 3 month ]
- Complications [ Time Frame: 3 month ]
- Cognitive function [ Time Frame: 3 month ]MMSE
- Emotional function [ Time Frame: 3 month ]HAD
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832351
|Department of Neurology, Akershus University Hospital|
|Lørenskog, Akershus, Norway, 1478|
|Study Chair:||Ole Morten Rønning, MD, PhD||Department of Neurology, Akershus University Hospital|