Ischemic Stroke and Early Vertical Positioning (SEVEL) (SEVEL)

December 16, 2014 updated by: Nantes University Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • University Hospital
      • Chateaubriand, France
        • Hospital
      • La Roche-sur-Yon, France
        • Hospital
      • Le Mans, France
        • Hospital
      • Lorient, France
        • Hospital
      • Nantes, France
        • University Hospital
      • Quimper, France
        • Hospital Cornouaille
      • Rennes, France
        • University Hospital
      • St Brieuc, France
        • Hospital Yves LeFoll
      • St Nazaire, France
        • Hospital
      • Tours, France
        • University Hospital
      • Vannes, France
        • Hospital Bretagne Atlantique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early vertical positioning
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: Progressively vertical positioning
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To demonstrate that neurological recovery is better at 7 days with an earlier mobilization protocol (NIHSS score)
Time Frame: 7 days
7 days
To demonstrate that neurological recovery is better at 3 months with an earlier mobilization protocol (NIHSS score)
Time Frame: 3 months
3 months
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
7 days
To demonstrate that the autonomy is better at 7 days in the early mobilization group (Barthel score)
Time Frame: 7 days
7 days
To demonstrate that the autonomy is better at 3 months in the early mobilization group (Barthel score)
Time Frame: 3 months
3 months
To demonstrate that an earlier " verticalization " shortens the length of stay in hospital
Time Frame: 7 days
7 days
To demonstrate that an earlier " verticalization " allows the patient to go back home sooner
Time Frame: 7 days
7 days
To assess the tolerance of an early mobilization
Time Frame: 3 months
3 months
To assess the impact of an early mobilization on the post stroke fatigue
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Fanny HERISSON, Doctor, Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

April 5, 2012

First Submitted That Met QC Criteria

April 5, 2012

First Posted (Estimate)

April 9, 2012

Study Record Updates

Last Update Posted (Estimate)

December 17, 2014

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/4-C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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