Ischemic Stroke and Early Vertical Positioning (SEVEL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01573299
First received: April 5, 2012
Last updated: November 2, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Early Mobilisation in Ischemic Stroke Patients
Other: Mobilization of stroke patients

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official 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

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573299

Contacts
Contact: Fanny HERISSON, MD PhD +33 240165199 fannyherisson@yahoo.fr

Locations
France
University Hospital Recruiting
Angers, France
Contact: Guillaume MARC, Doctor       gumarc@chu-angers.fr   
Principal Investigator: Guillaume MARC, Doctor         
Hospital Recruiting
Chateaubriand, France
Contact: Emmanuelle DOURY, Doctor       emmanuelle.doury@ch-chateaubriant.fr   
Principal Investigator: Emmanuelle DOURY, Doctor         
Hospital Recruiting
La Roche-sur-Yon, France
Contact: Cédric URBANCZYK, Doctor       ced_u@yahoo.fr   
Principal Investigator: Cedric URBANCZYK, Doctor         
Hospital Recruiting
Le Mans, France
Contact: Alain LEGOUT, Doctor       alegout@ch-lemans.fr   
Contact: Yolaine OLLIVIER, Doctor       yollivier@ch-lemans.fr   
Principal Investigator: Alain LEGOUT, Doctor         
Sub-Investigator: Yolaine OLLIVIER         
Hospital Recruiting
Lorient, France
Contact: Eric SARTORI, PH       e.sartori@ch-bretagne-sud.fr   
Principal Investigator: Eric SARTORI, PH         
University Hospital Recruiting
Nantes, France
Contact: Fanny HERISSON, Doctor    +33 240165199    fannyherisson@yahoo.fr   
Principal Investigator: Fanny HERISSON, Doctor         
Hospital Cornouaille Recruiting
Quimper, France
Contact: Christophe BREUILLY, Doctor       c.breuilly@ch-cornouaille.fr   
Principal Investigator: Christophe BREUILLY, Doctor         
University Hospital Recruiting
Rennes, France
Contact: Thomas RONZIERE       thomas.ronziere@chu-rennes.fr   
Principal Investigator: Thomas RONZIERE, Doctor         
Hospital Yves LeFoll Recruiting
St Brieuc, France
Contact: Claudia VADUVA, Doctor       claudia.vaduva@ch-stbrieuc.fr   
Principal Investigator: Claudia VADUVA, Doctor         
Hospital Recruiting
St Nazaire, France
Contact: Catherine BERTOUT LEMERCIER, Doctor       c.bertout@ch-saintnazaire.fr   
Principal Investigator: Catherine BERTOUT LEMERCIER, Doctor         
University Hospital Recruiting
Tours, France
Contact: Isabelle BONNAUD, Doctor       I.BONNAUD@chu-tours.fr   
Principal Investigator: Isabelle BONNAUD, Doctor         
Hospital Bretagne Atlantique Recruiting
Vannes, France
Contact: Nicolas CHAUSSON, Doctor       nicolas.chausson@ch-bretagne-atlantique.fr   
Principal Investigator: Nicolas CHAUSSON, Doctor         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Fanny HERISSON, Doctor Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01573299     History of Changes
Other Study ID Numbers: 11/4-C
Study First Received: April 5, 2012
Last Updated: November 2, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Cerebral Infarction, Mobilization, Recovery

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on October 02, 2014