Trial record 14 of 4017 for:
Stroke
Ischemic Stroke and Early Vertical Positioning (SEVEL)
This study is currently recruiting participants.
Verified November 2012 by Nantes University Hospital
Sponsor:
Nantes University Hospital
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
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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
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 Pathologic Processes Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 16, 2013