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Cerebral Blood Flow-guided Early Rehabilitation Intervention After Stroke: a Pilot Randomized Trial (STAND-OP) (STAND-OP)

29 november 2021 bijgewerkt door: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Cerebral Blood Flow-guided Early Rehabilitation Intervention After Stroke: a Pilot Randomized Trial

The primary goal of most acute stroke interventions is to restore cerebral blood flow (CBF) in the affected region and prevent hypoperfusion during early clinical course. Diffuse optical technology offers a new opportunity for invasive, real time and bedside assessment of brain function biomarkers, including CBF. However, whether CBF monitoring can identify patients who are most likely to benefit from therapies is unclear Recently, it was suggested that the benefit of early mobilization (EM) after stroke on motor recovery may be outweighed by a deleterious effect on cerebral perfusion if cerebral autoregulation (CA) is impaired. Hypothetically, EM could improve recovery outcomes after stroke in selected patients based on CA function. Our objective is to investigate if EM leads to superior motor and functional outcome after stroke compared to standard care (SC) in selected patients based on optical biomarkers of CA and evaluate the feasibility of the clinical use of a novel transcranial optical monitoring system adapted to deliver biomarkers of CA at the bedside. The investigators designed a randomized controlled, open-labeled trial with blinded assessment of outcome end-points in a stroke unit of a tertiary stroke center. Patients with an ischemic or hemorrhagic stroke will be recruited and randomly assigned within 24 hours after symptoms onset to receive SC alone or EM in addition to SC. All patients will undergo optical monitoring of CA on admission to the Stroke Unit during the first mobilization. Randomization will be stratified by stroke severity and type of stroke. Clinical outcome will be assessed with the Postural Assessment Scale for Stroke (PASS) and modified Rankin scale at 90 days. Safety outcome will be assessed by recording the incidence of neurological deterioration, recurrence and falls.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Background: The primary goal of most acute stroke interventions is to restore cerebral blood flow (CBF) in the affected region and prevent hypoperfusion during early clinical course. Diffuse optical technology offers a new opportunity for invasive, real time and bedside assessment of brain function biomarkers, including CBF.

However, whether CBF monitoring can identify patients who are most likely to benefit from therapies is unclear. The results of AVERT trial suggested that the benefit of early mobilization (EM) after stroke on functional outcome may be outweighed by a hypothetical deleterious effect on cerebral perfusion if cerebral autoregulation (CA) is impaired. EM could improve recovery outcomes after stroke in selected patients based on the status of CA function.

Objectives: 1) to investigate if EM leads to superior motor and functional outcome after stroke compared to standard care (SC) in selected patients based on optical biomarkers of CA. 2) To evaluate the feasibility of the clinical use of a novel transcranial optical monitoring system adapted to deliver biomarkers of CA at the bedside.

Methodology: A randomized controlled, open-labeled trial with blinded assessment of outcome end-points in a stroke unit of a tertiary stroke center. Patients with an ischemic or hemorrhagic stroke will be randomly assigned within 24 hours after symptoms onset to receive SC alone or EM in addition to SC. All patients will undergo optical monitoring of CA on admission to the Stroke Unit. Randomization will be stratified according to stroke severity measured with the National institute of Health Stroke Scale (NIHSS) and type of stroke (ischemic or hemorrhagic). Clinical outcome will be assessed with the Postural Assessment Scale for Stroke (PASS) and modified Rankin scale at 90 days. Safety outcome will be assessed by recording the incidence of neurological deterioration, recurrence and falls.

Expected results: to provide a new in vivo biomarker of cerebrovascular function for more accurate and earlier prediction of response to therapy, leading to improved clinical decisions and outcomes.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

106

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Spanje
      • Barcelona, Spanje, 08025
        • Hospital Santa Creu i Sant Pau

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Patients 18 years or over, with a clinical diagnosis of first or recurrent stroke, either ischemic or hemorrhagic.
  • Recruitment within 24 hours of onset of stroke symptoms.
  • Admission to the stroke unit
  • Informed consent obtained from the patient or responsible third party

Exclusion Criteria:

  • Pre-stroke modified Rankin scale score >3
  • Transient ischemic attacks
  • Exclusively retinal stroke
  • Deterioration in patient´s neurological condition in the first hours of admission resulting in urgent surgery, admission to ICU or a documented decision for palliative care.
  • Unstable medical condition
  • A suspected or confirmed lower limb fracture at the time of stroke preventing the implementation of the mobilization protocol.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Standard care group
Standard of care (SC) mobility protocol performed by the Stroke Unit nursing and physiotherapy staff. The SC consists of one or two sessions per days of out-of-bed sitting and standing, adapted to patient´s tolerability, and one session of physiotherapy per day. Mobilization will be schedule to start from 24 hours from symptoms onset according to the local Stroke Unit protocol.
Ander: Standard care
Standard protocol of mobilization in acute stroke patients admitted to the Stroke Unit at the discretion of the nursing and physiotherapy staff
Experimenteel: Intensive mobilization group
The Intensive mobilization intervention will include the standard care plus at least two additional sessions each day of at least 20 minutes each session focused on task specific sitting, standing and walking activities. The intervention will be schedule to start at 24 hours from symptoms onset and will last 14 days or until the patient is discharged.
Ander: Early Mobilization
Additional 2 or more sessions of out-of-bed activity to the standard stroke care, focused in active sitting, standing and walking assisted by physiotherapists

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Postural Assessment Scale for Stroke
Tijdsspanne: 90 days
Balance and mobility assessed with the Postural Assessment Scale for Stroke patients (PASS), in its validated Spanish version. The PASS contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting, or standing posture. Each item is scored from 0 to 3, with 0 being the lowest level of functionality and 3 the highest. The total score ranges from 0 to 36 (highest score best).
90 days

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Health-related quality of life
Tijdsspanne: Discharge and 90 days
Assessment of Quality of life with the questionnaire EuroQol 5 Dimensions (5D) 5 Levels (5L) (EQ-5D-5L), where 1 means no problems and 5 means extreme problems in each dimension (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).
Discharge and 90 days
Modified Rankin scale
Tijdsspanne: 90 days
Functional assessment with the modified Rankin scale (0 to 6, highest score worse).
90 days
Neurological deterioration measured with the NIHSS
Tijdsspanne: 14 days
Neurological deterioration during hospitalization measured as an increase in the NIHSS score in 2 or more points score (early at 24 hours and during the intervention)
14 days
Recurrent Stroke
Tijdsspanne: 90 days
Stroke recurrence during hospitalization
90 days
Falls after stroke
Tijdsspanne: 90 days
Reported incidence of Falls after stroke
90 days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Medewerkers

Fundació La Marató de TV3

Onderzoekers

  • Hoofdonderzoeker: Raquel Delgado-Mederos, MD, PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 april 2019

Primaire voltooiing (Werkelijk)

18 oktober 2021

Studie voltooiing (Werkelijk)

18 oktober 2021

Studieregistratiedata

Eerst ingediend

6 april 2021

Eerst ingediend dat voldeed aan de QC-criteria

13 april 2021

Eerst geplaatst (Werkelijk)

19 april 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 december 2021

Laatste update ingediend die voldeed aan QC-criteria

29 november 2021

Laatst geverifieerd

1 november 2021

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IIBSP-CBF-2017-52

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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