Clinical trial NCT01573299: Ischemic Stroke and Early Vertical Positioning (SEVEL)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Early Mobilisation in Ischemic Stroke Patients
Keywords: Cerebral Infarction, Mobilization, Recovery
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-04-09
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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". 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* Patients displaying a loss of autonomy with a Rankin score \>3 previous to stroke onset.
* Patient's refusal
* Patient under legal protection

Primary outcomes:
measure: To demonstrate that functional modified Rankin score at 3 months after stroke onset is better with an earlier mobilization protocol (Rankin score)
timeFrame: 3 months
Secondary outcomes:
measure: To demonstrate that neurological recovery is better at 7 days with an earlier mobilization protocol (NIHSS score)
timeFrame: 7 days
measure: To demonstrate that neurological recovery is better at 3 months with an earlier mobilization protocol (NIHSS score)
timeFrame: 3 months
measure: To demonstrate that functional modified Rankin score at 7 days after stroke onset is better with an earlier mobilization protocol (Rankin score)
timeFrame: 7 days
measure: To demonstrate that the autonomy is better at 7 days in the early mobilization group (Barthel score)
timeFrame: 7 days
measure: To demonstrate that the autonomy is better at 3 months in the early mobilization group (Barthel score)
timeFrame: 3 months
measure: To demonstrate that an earlier " verticalization " shortens the length of stay in hospital
timeFrame: 7 days
measure: To demonstrate that an earlier " verticalization " allows the patient to go back home sooner
timeFrame: 7 days
measure: To assess the tolerance of an early mobilization
timeFrame: 3 months
measure: To assess the impact of an early mobilization on the post stroke fatigue
timeFrame: 3 months
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
city: Chateaubriand
country: France
facility: Hospital
city: La Roche-sur-Yon
country: France
facility: Hospital
city: Le Mans
country: France
facility: Hospital
city: Lorient
country: France
facility: Hospital
city: Nantes
country: France
facility: University Hospital
city: Quimper
country: France
facility: Hospital Cornouaille
city: Rennes
country: France
facility: University Hospital
city: St Brieuc
country: France
facility: Hospital Yves LeFoll
city: St Nazaire
country: France
facility: Hospital
city: Tours
country: France
facility: University Hospital
city: Vannes
country: France
facility: Hospital Bretagne Atlantique
Study officials:
affiliation: Nantes University Hospital
name: Fanny HERISSON, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.