NCT00832351

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

January 1, 2016

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

January 29, 2009

Last Update Submit

December 30, 2015

Conditions

Stroke

Keywords

StrokeBrain infarctionIntracerebral hemorrhageEarly Mobilisation

Outcome Measures

Primary Outcomes (1)

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

    3 month

Secondary Outcomes (5)

  • Neurological deficits

    3 month

  • Morbidity

    3 month

  • Complications

    3 month

  • Cognitive function

    3 month

  • Emotional function

    3 month

Study Arms (2)

1

EXPERIMENTAL

Early mobilisation within 24 hours after admittance to hospital

Procedure: Mobilisation

2

NO INTERVENTION

Mobilisation after 24 but within 48 hours from admittance to hospital

Interventions

MobilisationPROCEDURE

Mobilisation

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients admitted to the Department of Neurology, Akershus University Hospital, with acute stroke (ischemic or hemorrhagic)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Akershus University Hospital

Lørenskog, Akershus, 1478, Norway

Location

MeSH Terms

Conditions

StrokeBrain InfarctionCerebral Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain IschemiaInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisIntracranial HemorrhagesHemorrhage

Study Officials

  • Ole Morten Rønning, MD, PhD

    Department of Neurology, Akershus University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 29, 2009

First Posted

January 30, 2009

Study Start

March 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

January 1, 2016

Record last verified: 2015-12

Locations

NO(1)