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

29 novembre 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

106

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: Standard care
Standard protocol of mobilization in acute stroke patients admitted to the Stroke Unit at the discretion of the nursing and physiotherapy staff
Sperimentale: 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.
Altro: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postural Assessment Scale for Stroke
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Health-related quality of life
Lasso di tempo: 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
Lasso di tempo: 90 days
Functional assessment with the modified Rankin scale (0 to 6, highest score worse).
90 days
Neurological deterioration measured with the NIHSS
Lasso di tempo: 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
Lasso di tempo: 90 days
Stroke recurrence during hospitalization
90 days
Falls after stroke
Lasso di tempo: 90 days
Reported incidence of Falls after stroke
90 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

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

Collaboratori

Fundació La Marató de TV3

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 aprile 2019

Completamento primario (Effettivo)

18 ottobre 2021

Completamento dello studio (Effettivo)

18 ottobre 2021

Date di iscrizione allo studio

Primo inviato

6 aprile 2021

Primo inviato che soddisfa i criteri di controllo qualità

13 aprile 2021

Primo Inserito (Effettivo)

19 aprile 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 dicembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 novembre 2021

Ultimo verificato

1 novembre 2021

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IIBSP-CBF-2017-52

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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