Akershus Early Mobilisation in Stroke Study

Stroke Clinical Trial

— AKEMIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832351
• Other study ID #: 1.2006.322 (REK)
• Secondary ID: 04/01666-22 (NSD
• Status: Completed
• Phase: N/A
• First received: January 29, 2009
• Last updated: December 30, 2015
• Start date: March 2009
• Est. completion date: May 2010

Study information

• Verified date: December 2015
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• Mobilisation
Mobilisation

Locations

Country	Name	City	State
Norway	Department of Neurology, Akershus University Hospital	Lørenskog	Akershus

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Akershus	South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of early mobilisation after stroke (< 24 hours after admittance to hospital) on mortality, morbidity and functional outcome		3 month	No
Secondary	Neurological deficits	NIHSS	3 month	No
Secondary	Morbidity		3 month	No
Secondary	Complications		3 month	No
Secondary	Cognitive function	MMSE	3 month	No
Secondary	Emotional function	HAD	3 month	No