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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
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early vertical positioning | Active Comparator |
| |
| Progressively vertical positioning | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobilization of stroke patients | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate that functional modified Rankin score at 3 months after stroke onset is better with an earlier mobilization protocol (Rankin score) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate that neurological recovery is better at 7 days with an earlier mobilization protocol (NIHSS score) | 7 days | |
| To demonstrate that neurological recovery is better at 3 months with an earlier mobilization protocol (NIHSS score) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fanny HERISSON, Doctor | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Angers | France | ||||
| Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27023901 | Derived | 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. |
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| ID | Term |
|---|---|
| D002544 | Cerebral Infarction |
| ID | Term |
|---|---|
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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|
| To demonstrate that functional modified Rankin score at 7 days after stroke onset is better with an earlier mobilization protocol (Rankin score) | 7 days |
| To demonstrate that the autonomy is better at 7 days in the early mobilization group (Barthel score) | 7 days |
| To demonstrate that the autonomy is better at 3 months in the early mobilization group (Barthel score) | 3 months |
| To demonstrate that an earlier " verticalization " shortens the length of stay in hospital | 7 days |
| To demonstrate that an earlier " verticalization " allows the patient to go back home sooner | 7 days |
| To assess the tolerance of an early mobilization | 3 months |
| To assess the impact of an early mobilization on the post stroke fatigue | 3 months |
| Châteaubriand |
| France |
| Hospital | La Roche-sur-Yon | France |
| Hospital | Le Mans | France |
| Hospital | Lorient | France |
| University Hospital | Nantes | France |
| Hospital Cornouaille | Quimper | France |
| University Hospital | Rennes | France |
| Hospital Yves LeFoll | Saint-Brieuc | France |
| Hospital | Saint-Nazaire | France |
| University Hospital | Tours | France |
| Hospital Bretagne Atlantique | Vannes | France |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |