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

16. december 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

167

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Early vertical positioning
Andet: 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.
Aktiv komparator: Progressively vertical positioning
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
To demonstrate that functional modified Rankin score at 3 months after stroke onset is better with an earlier mobilization protocol (Rankin score)
Tidsramme: 3 months
3 months

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nantes University Hospital

Efterforskere

  • Ledende efterforsker: Fanny HERISSON, Doctor, Nantes University Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2011

Primær færdiggørelse (Faktiske)

1. august 2014

Studieafslutning (Faktiske)

1. august 2014

Datoer for studieregistrering

Først indsendt

5. april 2012

Først indsendt, der opfyldte QC-kriterier

5. april 2012

Først opslået (Skøn)

9. april 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. december 2014

Sidst verificeret

1. december 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 11/4-C

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Mobilization of stroke patients

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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