Ischemic Stroke and Early Vertical Positioning (SEVEL)
- Conditions
- Early Mobilisation in Ischemic Stroke Patients
- Interventions
- Other: Mobilization of stroke patients
- Registration Number
- NCT01573299
- Lead Sponsor
- Nantes University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 167
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early vertical positioning Mobilization of stroke patients - Progressively vertical positioning Mobilization of stroke patients -
- Primary Outcome Measures
Name Time Method To demonstrate that functional modified Rankin score at 3 months after stroke onset is better with an earlier mobilization protocol (Rankin score) 3 months
- Secondary Outcome Measures
Name Time Method To demonstrate that neurological recovery is better at 7 days with an earlier mobilization protocol (NIHSS score) 7 days To demonstrate that the autonomy is better at 7 days in the early mobilization group (Barthel score) 7 days To assess the impact of an early mobilization on the post stroke fatigue 3 months To demonstrate that neurological recovery is better at 3 months with an earlier mobilization protocol (NIHSS score) 3 months To demonstrate that an earlier " verticalization " shortens the length of stay in hospital 7 days To demonstrate that an earlier " verticalization " allows the patient to go back home sooner 7 days To assess the tolerance of an early mobilization 3 months To demonstrate that functional modified Rankin score at 7 days after stroke onset is better with an earlier mobilization protocol (Rankin score) 7 days To demonstrate that the autonomy is better at 3 months in the early mobilization group (Barthel score) 3 months
Trial Locations
- Locations (5)
University Hospital
🇫🇷Tours, France
Hospital
🇫🇷St Nazaire, France
Hospital Cornouaille
🇫🇷Quimper, France
Hospital Yves LeFoll
🇫🇷St Brieuc, France
Hospital Bretagne Atlantique
🇫🇷Vannes, France