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

NCT04848285 | Completed DMC

• 1 other identifier: IIBSP-CBF-2017-52
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Health-related quality of life

  Discharge and 90 days

• Modified Rankin scale

  90 days

• Neurological deterioration measured with the NIHSS

  14 days

• Recurrent Stroke

  90 days

• Falls after stroke

  90 days

Study Arms (2)

Standard care group

ACTIVE COMPARATOR

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.

Other: Standard care

Intensive mobilization group

EXPERIMENTAL

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.

Other: Early Mobilization

Interventions

Early Mobilization OTHER

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

Intensive mobilization group

Standard care OTHER

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

Standard care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Fundació La Marató de TV3: collaborator

Study Sites (1)

Hospital Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Stroke

Interventions

Early Ambulation; Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Raquel Delgado-Mederos, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 19, 2021
• Study Start: April 2, 2019
• Primary Completion: October 18, 2021
• Study Completion: October 18, 2021
• Last Updated: December 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)