Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Ischemic Stroke and Early Vertical Positioning (SEVEL)

This study has been terminated.
(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)
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01573299
First received: April 5, 2012
Last updated: December 16, 2014
Last verified: December 2014

April 5, 2012
December 16, 2014
November 2011
August 2014   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01573299 on ClinicalTrials.gov Archive Site
  • To demonstrate that neurological recovery is better at 7 days with an earlier mobilization protocol (NIHSS score) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • To demonstrate that neurological recovery is better at 3 months with an earlier mobilization protocol (NIHSS score) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To demonstrate that the autonomy is better at 7 days in the early mobilization group (Barthel score) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • To demonstrate that the autonomy is better at 3 months in the early mobilization group (Barthel score) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To demonstrate that an earlier " verticalization " shortens the length of stay in hospital [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • To demonstrate that an earlier " verticalization " allows the patient to go back home sooner [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • To assess the tolerance of an early mobilization [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To assess the impact of an early mobilization on the post stroke fatigue [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ischemic Stroke and Early Vertical Positioning (SEVEL)
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Early Mobilisation in Ischemic Stroke Patients
Other: Mobilization of stroke patients
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.
  • Active Comparator: Early vertical positioning
    Intervention: Other: Mobilization of stroke patients
  • Active Comparator: Progressively vertical positioning
    Intervention: Other: Mobilization of stroke patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
167
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01573299
11/4-C
Yes
Nantes University Hospital
Nantes University Hospital
Not Provided
Principal Investigator: Fanny HERISSON, Doctor Nantes University Hospital
Nantes University Hospital
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP