StrokeAKEMISNCT00832351
Akershus Early Mobilisation in Stroke Study
A study testing Mobilisation in people with Stroke, run by University Hospital, Akershus at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Mobilisation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2009to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients admitted to the Department of Neurology, Akershus University Hospital, with acute stroke (ischemic or hemorrhagic)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Neurology, Akershus University Hospital
Lørenskog, Akershus, 1478
About this study
Official title: Effect of Immediate Mobilisation After Stroke on Mortality, Morbidity and Functional Outcome
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.
Read more
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
- Being tested
- Mobilisation
- Keywords
- Stroke, Brain infarction, Intracerebral hemorrhage, Early Mobilisation
- Medical subject headings
- Stroke, Brain Infarction, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobilisationProcedure or surgery
Mobilisation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Early mobilisation within 24 hours after admittance to hospital Receives: Procedure: Mobilisation |
| 2 | No intervention | Mobilisation after 24 but within 48 hours from admittance to hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of early mobilisation after stroke (< 24 hours after admittance to hospital) on mortality, morbidity and functional outcome
Measured: 3 month
Secondary outcomes (5)
Neurological deficits
NIHSS
Measured: 3 month
Morbidity
Measured: 3 month
Complications
Measured: 3 month
Cognitive function
MMSE
Measured: 3 month
Emotional function
HAD
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Responsible party
- Principal investigator, Antje Sundseth, University Hospital, Akershus
- Investigators
- Ole Morten Rønning, MD, PhD, Study chair, Department of Neurology, Akershus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832351
- Sponsor's protocol ID
- 1.2006.322 (REK)
- Other IDs
- 04/01666-22 (NSD)
- Acronym
- AKEMIS
- Status last verified
- Dec 2015
- First submitted
- 29 Jan 2009
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immediate Mobilisation After Stroke on Mortality, Morbidity and Functional Outcome
- ClinicalTrials.gov ID
- NCT00832351
- Acronym / sponsor ID
- AKEMIS / 1.2006.322 (REK)
- Conditions
- Stroke
- Keywords
- Stroke, Brain infarction, Intracerebral hemorrhage, Early Mobilisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Study start
- Mar 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: MobilisationEarly mobilisation within 24 hours after admittance to hospital |
| 2 | No intervention | –Mobilisation after 24 but within 48 hours from admittance to hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients admitted to the Department of Neurology, Akershus University Hospital, with acute stroke (ischemic or hemorrhagic)
Key exclusion criteria (7 listed)
- admitted to hospital more than 24 hours after stroke onset
- mRS 0 and 1
- mRS 5
- patients requiring palliative care
- secondary/traumatic intracerebral hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MobilisationMobilisation | Procedure or surgery | 1 |
Primary outcome
Effect of early mobilisation after stroke (< 24 hours after admittance to hospital) on mortality, morbidity and functional outcome
Time frame: 3 month
5 secondary outcomes
Neurological deficits
Time frame: 3 month
Morbidity
Time frame: 3 month
Complications
Time frame: 3 month
Cognitive function
Time frame: 3 month
Emotional function
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole Morten Rønning, MD, PhD study chair
Department of Neurology, Akershus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilisation in people with Stroke, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of early mobilisation after stroke (< 24 hours after admittance to hospital) on mortality, morbidity and functional outcome (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2016.