Akershus Early Mobilisation in Stroke Study

NCT ID: NCT00832351

Last Updated: 2016-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-05-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Early mobilisation within 24 hours after admittance to hospital

Group Type: EXPERIMENTAL

Mobilisation

Intervention Type: PROCEDURE

Mobilisation

2

Mobilisation after 24 but within 48 hours from admittance to hospital

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mobilisation

Mobilisation

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South-Eastern Norway Regional Health Authority

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: lead

Responsible Party

Antje Sundseth

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ole Morten Rønning, MD, PhD

Role: STUDY_CHAIR

Department of Neurology, Akershus University Hospital

Locations

Department of Neurology, Akershus University Hospital

Lørenskog, Akershus, Norway

Countries

Norway

Other Identifiers

04/01666-22 (NSD)

Identifier Type: -

Identifier Source: secondary_id

1.2006.322 (REK)

Identifier Type: -

Identifier Source: org_study_id