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Akershus Early Mobilisation in Stroke Study (AKEMIS)

This study has been completed.
Sponsor:
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Antje Sundseth, Akershus University College
ClinicalTrials.gov Identifier:
NCT00832351
First received: January 29, 2009
Last updated: November 18, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention
Stroke
 Procedure: Mobilisation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Immediate Mobilisation After Stroke on Mortality, Morbidity and Functional Outcome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Akershus:

Primary Outcome Measures:
  • Effect of early mobilisation after stroke (< 24 hours after admittance to hospital) on mortality, morbidity and functional outcome [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurological deficits [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    NIHSS

  • Morbidity [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Cognitive function [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    MMSE

  • Emotional function [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    HAD


Enrollment: 65
Study Start Date: March 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Early mobilisation within 24 hours after admittance to hospital
 Procedure: Mobilisation
Mobilisation
No Intervention: 2
Mobilisation after 24 but within 48 hours from admittance to hospital

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832351

Locations
Norway
Department of Neurology, Akershus University Hospital
Lørenskog, Akershus, Norway, 1478
Sponsors and Collaborators
University Hospital, Akershus
South-Eastern Norway Regional Health Authority
Investigators
Study Chair: Ole Morten Rønning, MD, PhD Department of Neurology, Akershus University Hospital
  More Information

No publications provided

Responsible Party: Antje Sundseth, MD, Akershus University College
ClinicalTrials.gov Identifier: NCT00832351     History of Changes
Other Study ID Numbers: 1.2006.322 (REK), 04/01666-22 (NSD)
Study First Received: January 29, 2009
Last Updated: November 18, 2011
Health Authority: Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University Hospital, Akershus:
Stroke
Brain infarction
Intracerebral hemorrhage
Early Mobilisation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 23, 2013