search
Back to results

Akershus Early Mobilisation in Stroke Study (AKEMIS)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Mobilisation
Sponsored by
University Hospital, Akershus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Brain infarction, Intracerebral hemorrhage, Early Mobilisation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neurology, Akershus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Early mobilisation within 24 hours after admittance to hospital

Mobilisation after 24 but within 48 hours from admittance to hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Neurological deficits
NIHSS
Morbidity
Complications
Cognitive function
MMSE
Emotional function
HAD

Full Information

First Posted
January 29, 2009
Last Updated
December 30, 2015
Sponsor
University Hospital, Akershus
Collaborators
South-Eastern Norway Regional Health Authority
search

1. Study Identification

Unique Protocol Identification Number
NCT00832351
Brief Title
Akershus Early Mobilisation in Stroke Study
Acronym
AKEMIS
Official Title
Effect of Immediate Mobilisation After Stroke on Mortality, Morbidity and Functional Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus
Collaborators
South-Eastern Norway Regional Health Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Brain infarction, Intracerebral hemorrhage, Early Mobilisation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Early mobilisation within 24 hours after admittance to hospital
Arm Title
2
Arm Type
No Intervention
Arm Description
Mobilisation after 24 but within 48 hours from admittance to hospital
Intervention Type
Procedure
Intervention Name(s)
Mobilisation
Intervention Description
Mobilisation
Primary Outcome Measure Information:
Title
Effect of early mobilisation after stroke (< 24 hours after admittance to hospital) on mortality, morbidity and functional outcome
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Neurological deficits
Description
NIHSS
Time Frame
3 month
Title
Morbidity
Time Frame
3 month
Title
Complications
Time Frame
3 month
Title
Cognitive function
Description
MMSE
Time Frame
3 month
Title
Emotional function
Description
HAD
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole Morten Rønning, MD, PhD
Organizational Affiliation
Department of Neurology, Akershus University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Neurology, Akershus University Hospital
City
Lørenskog
State/Province
Akershus
ZIP/Postal Code
1478
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

Akershus Early Mobilisation in Stroke Study

We'll reach out to this number within 24 hrs