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NCT04848285: STAND-OP

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

Completed NA Last updated 10 December 2021
What this trial tests

NA trial testing Early Mobilization in Acute Stroke in 106 participants. Completed in 18 October 2021.

Timeline
2 April 2019
Primary endpoint
18 October 2021
18 October 2021

Quick facts

Lead sponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment106
Start date2 April 2019
Primary completion18 October 2021
Estimated completion18 October 2021
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

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

Who can join

18 and older, any sex, with Acute Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Early Mobilization

Trials testing the same drug.

Other recruiting trials for Acute Stroke

Currently open trials in the same condition.

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

Trials by the same sponsor.

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Data sources for this page

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