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

Acute Stroke Clinical Trial

— STAND-OP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04848285
• Other study ID #: IIBSP-CBF-2017-52
• Status: Completed
• Phase: N/A
• Start date: April 2, 2019
• Est. completion date: October 18, 2021

Study information

• Verified date: November 2021
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 18, 2021
• Est. primary completion date: October 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Other:
• 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
• Standard care
Standard protocol of mobilization in acute stroke patients admitted to the Stroke Unit at the discretion of the nursing and physiotherapy staff

Locations

Country	Name	City	State
Spain	Hospital Santa Creu i Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Fundació La Marató de TV3

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postural Assessment Scale for Stroke	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
Secondary	Health-related quality of life	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
Secondary	Modified Rankin scale	Functional assessment with the modified Rankin scale (0 to 6, highest score worse).	90 days
Secondary	Neurological deterioration measured with the NIHSS	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
Secondary	Recurrent Stroke	Stroke recurrence during hospitalization	90 days
Secondary	Falls after stroke	Reported incidence of Falls after stroke	90 days