Ischemic Stroke and Early Vertical Positioning (SEVEL)

NCT ID: NCT01573299

Last Updated: 2014-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Early Mobilisation in Ischemic Stroke Patients

Keywords

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Cerebral Infarction, Mobilization, Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Early vertical positioning

Group Type ACTIVE_COMPARATOR

Mobilization of stroke patients

Intervention Type OTHER

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.

Progressively vertical positioning

Group Type ACTIVE_COMPARATOR

Mobilization of stroke patients

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fanny HERISSON, Doctor

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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University Hospital

Angers, , France

Site Status

Hospital

Châteaubriand, , France

Site Status

Hospital

La Roche-sur-Yon, , France

Site Status

Hospital

Le Mans, , France

Site Status

Hospital

Lorient, , France

Site Status

University Hospital

Nantes, , France

Site Status

Hospital Cornouaille

Quimper, , France

Site Status

University Hospital

Rennes, , France

Site Status

Hospital Yves LeFoll

Saint-Brieuc, , France

Site Status

Hospital

Saint-Nazaire, , France

Site Status

University Hospital

Tours, , France

Site Status

Hospital Bretagne Atlantique

Vannes, , France

Site Status

Countries

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France

References

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Herisson F, Godard S, Volteau C, Le Blanc E, Guillon B, Gaudron M; SEVEL study group. Early Sitting in Ischemic Stroke Patients (SEVEL): A Randomized Controlled Trial. PLoS One. 2016 Mar 29;11(3):e0149466. doi: 10.1371/journal.pone.0149466. eCollection 2016.

Reference Type DERIVED
PMID: 27023901 (View on PubMed)

Other Identifiers

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11/4-C

Identifier Type: -

Identifier Source: org_study_id