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Ischemic Stroke and Early Vertical Positioning (SEVEL)

N

Nantes University Hospital (NUH)

Status

Terminated

Conditions

Early Mobilisation in Ischemic Stroke Patients

Treatments

Other: Mobilization of stroke patients

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

167 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

167 participants in 2 patient groups

Early vertical positioning
Active Comparator group
Treatment:
Other: Mobilization of stroke patients
Progressively vertical positioning
Active Comparator group
Treatment:
Other: Mobilization of stroke patients

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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