Early Mobilisation in Ischemic Stroke Patients Clinical Trial
— SEVELOfficial 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.
| Status | Terminated |
| Enrollment | 167 |
| Est. completion date | August 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital | Angers | |
| France | Hospital | Chateaubriand | |
| France | Hospital | La Roche-sur-Yon | |
| France | Hospital | Le Mans | |
| France | Hospital | Lorient | |
| France | University Hospital | Nantes | |
| France | Hospital Cornouaille | Quimper | |
| France | University Hospital | Rennes | |
| France | Hospital Yves LeFoll | St Brieuc | |
| France | Hospital | St Nazaire | |
| France | University Hospital | Tours | |
| France | Hospital Bretagne Atlantique | Vannes |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To demonstrate that functional modified Rankin score at 3 months after stroke onset is better with an earlier mobilization protocol (Rankin score) | 3 months | No | |
| Secondary | To demonstrate that neurological recovery is better at 7 days with an earlier mobilization protocol (NIHSS score) | 7 days | No | |
| Secondary | To demonstrate that neurological recovery is better at 3 months with an earlier mobilization protocol (NIHSS score) | 3 months | No | |
| Secondary | To demonstrate that functional modified Rankin score at 7 days after stroke onset is better with an earlier mobilization protocol (Rankin score) | 7 days | No | |
| Secondary | To demonstrate that the autonomy is better at 7 days in the early mobilization group (Barthel score) | 7 days | No | |
| Secondary | To demonstrate that the autonomy is better at 3 months in the early mobilization group (Barthel score) | 3 months | No | |
| Secondary | To demonstrate that an earlier " verticalization " shortens the length of stay in hospital | 7 days | No | |
| Secondary | To demonstrate that an earlier " verticalization " allows the patient to go back home sooner | 7 days | No | |
| Secondary | To assess the tolerance of an early mobilization | 3 months | No | |
| Secondary | To assess the impact of an early mobilization on the post stroke fatigue | 3 months | No |