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Completed

NCT Number: NCT00832351

Akershus Early Mobilisation in Stroke Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, Akershus University Hospital

Lørenskog, Akershus, 1478, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobilisation

Procedure

Mobilisation

Primary outcomes

  1. Effect of early mobilisation after stroke (< 24 hours after admittance to hospital) on mortality, morbidity and functional outcome

    Time frame: 3 month

Secondary outcomes

  1. Neurological deficits

    Time frame: 3 month

    NIHSS

  2. Morbidity

    Time frame: 3 month

  3. Complications

    Time frame: 3 month

  4. Cognitive function

    Time frame: 3 month

    MMSE

  5. Emotional function

    Time frame: 3 month

    HAD

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • South-Eastern Norway Regional Health Authority

Registry information

Official study title

Effect of Immediate Mobilisation After Stroke on Mortality, Morbidity and Functional Outcome

Acronym: AKEMIS

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 30, 2009
Registry last updated
Jan 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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