Clinical trial NCT00832351: Akershus Early Mobilisation in Stroke Study
Official title: Effect of Immediate Mobilisation After Stroke on Mortality, Morbidity and Functional Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Brain infarction
Intracerebral hemorrhage
Early Mobilisation
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
First posted: 2009-01-30
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* patients admitted to the Department of Neurology, Akershus University Hospital, with acute stroke (ischemic or hemorrhagic)

Exclusion Criteria:

* admitted to hospital more than 24 hours after stroke onset
* mRS 0 and 1
* mRS 5
* patients requiring palliative care
* secondary/traumatic intracerebral hemorrhage
* pregnancy
* i.v./i.a. thrombolysis

Primary outcomes:
measure: Effect of early mobilisation after stroke (< 24 hours after admittance to hospital) on mortality, morbidity and functional outcome
timeFrame: 3 month
Secondary outcomes:
measure: Neurological deficits
timeFrame: 3 month
measure: Morbidity
timeFrame: 3 month
measure: Complications
timeFrame: 3 month
measure: Cognitive function
timeFrame: 3 month
measure: Emotional function
timeFrame: 3 month
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Department of Neurology, Akershus University Hospital
state: Akershus
Study officials:
affiliation: Department of Neurology, Akershus University Hospital
name: Ole Morten Rønning, MD, PhD
role: STUDY_CHAIR
References: