Early Mobilisation in Ischemic Stroke PatientsSEVELNCT01573299
Ischemic Stroke and Early Vertical Positioning (SEVEL)
A study testing Mobilization of stroke patients in people with Early Mobilisation in Ischemic Stroke Patients, run by Nantes University Hospital at 12 sites in France.
Trial summary
Even if it is a daily questioning for the stroke physician, no concrete recommendation exists regarding the time-point of the mobilization of stroke patients. In this study, we will compare two mobilisation strategies: early versus delayed "verticalisation". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Mobilisation in Ischemic Stroke Patients
- What is being tested?
- Mobilization of stroke patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 12 sitesFrance
- Study dates
- Nov 2011to Aug 2014
- 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
- Age 18 years or older
- Persistent neurological impairment at the participated time, related to an ischemic stroke defined by a sudden neurological deficit. The neurological deficit must not accompany hemorrhage on cerebral tomodensitometry which occurs on the same day or the day previous to the participation
- Patient hospitalized in Neurology department on the day of the participation
- Patient affiliated to the social security
Who cannot join
- Malignant cerebral infarction, loss of consciousness, comatose with GCS under 13, cerebral herniation, life- threatening infarction.
- Minor neurological deficit defined by isolated facial palsy, dysarthria, hemianopia, sensitive impairment, or every clinical condition that let the physician thinks that the stay in the hospital would be less than 72 hours.
- Known intracranial stenosis above 50% linked to the current infarction
- History of orthostatic neurological degradation
- Vomiting
- Deep venous thrombosis or suspicion of.
Show all 9Show fewer
- Patients displaying a loss of autonomy with a Rankin score >3 previous to stroke onset.
- Patient's refusal
- Patient under legal protection
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
University Hospital
Angers
Hospital
Châteaubriand
Hospital
La Roche-sur-Yon
Hospital
Le Mans
Hospital
Lorient
University Hospital
Nantes
Hospital Cornouaille
Quimper
University Hospital
Rennes
Hospital Yves LeFoll
Saint-Brieuc
Hospital
Saint-Nazaire
University Hospital
Tours
Hospital Bretagne Atlantique
Vannes
About this study
Official title: Ischemic Stroke and Early Vertical Positioning, the SEVEL Study: a Randomised Controlled Trial Comparing the 3 Months Rankin Score Outcome in Ischemic Stroke Patients; in Whom Early or Delayed Mobilization is Performed
Even if it is a daily questioning for the stroke physician, no concrete recommendation exists regarding the time-point of the mobilization of stroke patients. In this study, we will compare two mobilisation strategies: early versus delayed "verticalisation". 400 ischemic stroke patients will be included in this prospective randomized controlled trial, equally distributed in two groups. In the early mobilisation procedure the patient is allowed to go and sit outside of the bed the day after the stroke onset, whereas in the other arm, this procedure is delayed to the third day after stroke onset. The outcome in both groups will be assessed by the modified Rankin Scale at 3 months, which is commonly used in stroke study to investigate the functional outcome of the patients.
- Being tested
- Mobilization of stroke patients
- Keywords
- Cerebral Infarction, Mobilization, Recovery
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization of stroke patientsOther
In the first group (early vertical positioning)the patient can sit outside of the bed, the day after stroke onset. In the second group (progressively vertical positioning), the patient is progressively "verticalised" and is allowed to sit outside of the bed on the third day after the stroke onset.
| Study group | Role | What they receive |
|---|---|---|
| Early vertical positioning | Active comparator | Not described Receives: Other: Mobilization of stroke patients |
| Progressively vertical positioning | Active comparator | Not described Receives: Other: Mobilization of stroke patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that functional modified Rankin score at 3 months after stroke onset is better with an earlier mobilization protocol (Rankin score)
Measured: 3 months
Secondary outcomes (9)
To demonstrate that neurological recovery is better at 7 days with an earlier mobilization protocol (NIHSS score)
Measured: 7 days
To demonstrate that neurological recovery is better at 3 months with an earlier mobilization protocol (NIHSS score)
Measured: 3 months
To demonstrate that functional modified Rankin score at 7 days after stroke onset is better with an earlier mobilization protocol (Rankin score)
Measured: 7 days
To demonstrate that the autonomy is better at 7 days in the early mobilization group (Barthel score)
Measured: 7 days
To demonstrate that the autonomy is better at 3 months in the early mobilization group (Barthel score)
Measured: 3 months
To demonstrate that an earlier " verticalization " shortens the length of stay in hospital
Measured: 7 days
To demonstrate that an earlier " verticalization " allows the patient to go back home sooner
Measured: 7 days
To assess the tolerance of an early mobilization
Measured: 3 months
To assess the impact of an early mobilization on the post stroke fatigue
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2012 (estimated)
- Study startNov 2011
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: The required number of patients was not reached. The sites were not able to include more patients.Despite several actions the stop of the study has been decided
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Mobilisation in Ischemic Stroke PatientsStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fanny HERISSON, Doctor, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573299
- Sponsor's protocol ID
- 11/4-C
- Acronym
- SEVEL
- Status last verified
- Dec 2014
- First submitted
- 5 Apr 2012
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Herisson F, Godard S, Volteau C, Le Blanc E, Guillon B, Gaudron M; SEVEL study group. Early Sitting in Ischemic Stroke Patients (SEVEL): A Randomized Controlled Trial. PLoS One. 2016 Mar 29;11(3):e0149466. doi: 10.1371/journal.pone.0149466. eCollection 2016.
PubMed 27023901
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemic Stroke and Early Vertical Positioning, the SEVEL Study: a Randomised Controlled Trial Comparing the 3 Months Rankin Score Outcome in Ischemic Stroke Patients; in Whom Early or Delayed Mobilization is Performed
- ClinicalTrials.gov ID
- NCT01573299
- Acronym / sponsor ID
- SEVEL / 11/4-C
- Keywords
- Cerebral Infarction, Mobilization, Recovery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The required number of patients was not reached. The sites were not able to include more patients.Despite several actions the stop of the study has been decided
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 9 Apr 2012 (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.
Even if it is a daily questioning for the stroke physician, no concrete recommendation exists regarding the time-point of the mobilization of stroke patients. In this study, we will compare two mobilisation strategies: early versus delayed "verticalisation". 400 ischemic stroke patients will be included in this prospective randomized controlled trial, equally distributed in two groups. In the early mobilisation procedure the patient is allowed to go and sit outside of the bed the day after the stroke onset, whereas in the other arm, this procedure is delayed to the third day after stroke onset. The outcome in both groups will be assessed by the modified Rankin Scale at 3 months, which is commonly used in stroke study to investigate the functional outcome of the patients.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early vertical positioning | Active comparator | Other: Mobilization of stroke patients |
| Progressively vertical positioning | Active comparator | Other: Mobilization of stroke patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Persistent neurological impairment at the participated time, related to an ischemic stroke defined by a sudden neurological deficit. The neurological deficit must not accompany hemorrhage on cerebral tomodensitometry which occurs on the same day or the day previous to the participation
- Patient hospitalized in Neurology department on the day of the participation
- Patient affiliated to the social security
Key exclusion criteria (9 listed)
- Malignant cerebral infarction, loss of consciousness, comatose with GCS under 13, cerebral herniation, life- threatening infarction.
- Minor neurological deficit defined by isolated facial palsy, dysarthria, hemianopia, sensitive impairment, or every clinical condition that let the physician thinks that the stay in the hospital would be less than 72 hours.
- Known intracranial stenosis above 50% linked to the current infarction
- History of orthostatic neurological degradation
- Vomiting
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 |
|---|---|---|
| Mobilization of stroke patientsIn the first group (early vertical positioning)the patient can sit outside of the bed, the day after stroke onset. In the second group (progressively vertical positioning), the patient is progressively "verticalised" and is allowed to sit outside of the bed on the third day after the stroke onset. | Other | Early vertical positioning, Progressively vertical positioning |
Primary outcome
To demonstrate that functional modified Rankin score at 3 months after stroke onset is better with an earlier mobilization protocol (Rankin score)
Time frame: 3 months
9 secondary outcomes
To demonstrate that neurological recovery is better at 7 days with an earlier mobilization protocol (NIHSS score)
Time frame: 7 days
To demonstrate that neurological recovery is better at 3 months with an earlier mobilization protocol (NIHSS score)
Time frame: 3 months
To demonstrate that functional modified Rankin score at 7 days after stroke onset is better with an earlier mobilization protocol (Rankin score)
Time frame: 7 days
To demonstrate that the autonomy is better at 7 days in the early mobilization group (Barthel score)
Time frame: 7 days
To demonstrate that the autonomy is better at 3 months in the early mobilization group (Barthel score)
Time frame: 3 months
To demonstrate that an earlier " verticalization " shortens the length of stay in hospital
Time frame: 7 days
To demonstrate that an earlier " verticalization " allows the patient to go back home sooner
Time frame: 7 days
To assess the tolerance of an early mobilization
Time frame: 3 months
To assess the impact of an early mobilization on the post stroke fatigue
Time frame: 3 months
Results and safety
The study was stopped early (reason given: The required number of patients was not reached. The sites were not able to include more patients.Despite several actions the stop of the study has been decided). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
- Derived from this study: PubMed 27023901Herisson F, Godard S, Volteau C, Le Blanc E, Guillon B, Gaudron M; SEVEL study group. Early Sitting in Ischemic Stroke Patients (SEVEL): A Randomized Controlled Trial. PLoS One. 2016 Mar 29;11(3):e0149466. doi: 10.1371/journal.pone.0149466. eCollection 2016.
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.
Fanny HERISSON, Doctor principal investigator
Nantes University Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilization of stroke patients in people with Early Mobilisation in Ischemic Stroke Patients, run by Nantes University Hospital at 12 sites in France.
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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. 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 was stopped early (reason given: The required number of patients was not reached. The sites were not able to include more patients.Despite several actions the stop of the study has been decided). Results are not available in the source record.
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?
To demonstrate that functional modified Rankin score at 3 months after stroke onset is better with an earlier mobilization protocol (Rankin score) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01573299, which also lists 1 linked publication.
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 17 Dec 2014.