LEG-UP Feasibility Study: Elevated Leg Positioning For Acute Moderate Ischemic Stroke

NCT07483580 | Completed

• 1 other identifier: JRRMMC IRB No. 2024-279
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Augmentation of penumbral perfusion through nonpharmacological hemodynamic interventions such as patient positioning may offer a pragmatic approach to improve outcomes in acute ischemic stroke (AIS). This study aimed to assess the feasibility and safety of elevated leg positioning (ELP) in AIS, and to generate preliminary estimates of effect sizes to inform the design of a future definitive randomized trial.

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic stroke; patient positioning; leg elevation; large artery atherosclerosis; feasibility study

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants Adhering to the Assigned Elevated Leg Positioning (ELP) Intervention per Protocol

  The primary feasibility outcome was protocol adherence to the assigned elevated leg positioning (ELP) intervention in participants randomized to the intervention arm. Temporary interruption of ELP was permitted for up to three nonconsecutive periods of ≤30 minutes each. Adherence ≥80% prespecified as the threshold for feasibility.

  From enrollment to the end of treatment at 7 days.

• Number of Participants With Prespecified Adverse Events During the Treatment Period

  Occurrence of prespecified adverse events during the treatment period. Prespecified adverse events included headache, anxiety or fear, aspiration pneumonia, intracranial hemorrhage, venous thromboembolism (deep vein thrombosis or pulmonary embolism), and other cardiovascular or peripheral vascular events not present at baseline. Serious adverse events were defined according to International Council for Harmonisation Good Clinical Practice criteria and were adjudicated by an independent investigator.

  From enrollment to the end of treatment at 7 days.

Secondary Outcomes (4)

• Number of Participants With Early Neurologic Deterioration (END)

  Within 48 hours after randomization.

• Change from Baseline in the National Institutes of Health Stroke Scale (NIHSS) Score at Day 7

  Baseline and day 7 after randomization.

• Number of Participants With All-Cause Mortality at 30 Days

  30 days after randomization.

• Number of Participants With Favorable Functional Outcome at 90 Days

  90 days after randomization.

Study Arms (2)

Intervention

EXPERIMENTAL

In the intervention group, elevated leg positioning (ELP) was initiated within 30 minutes of randomization and no later than 24 hours after onset. Patients were positioned with passive elevation of the legs to 30° while maintaining a 0° head position using calibrated hospital beds. This was maintained for 24 hours, including during eating, drinking, and toileting. After 24 hours, mobilization with toilet privileges commenced, and patients were placed in ELP for 3 hours three times daily. Treatment protocol was continued for 7 days. Patients were instructed to report any discomfort while receiving ELP. If deemed uncomfortable or potentially harmful by the investigator, patient, or caregiver, ELP could be interrupted for up to three nonconsecutive periods of ≤30 minutes, during which patients were gradually returned to a horizontal position. All patients received standard medical management.

Other: Elevated Leg Positioning

Control

NO INTERVENTION

In the control group, no specific positional intervention was implemented. Patients were allowed to remain either in the supine or sitting position. All patients received standard medical management in accordance with prevailing guidelines.

Interventions

Elevated Leg Positioning OTHER

Elevated leg positioning (ELP) is a patient positioning strategy initiated no later than 24 hours after stroke onset. Patients are positioned with passive elevation of the legs to 30° while maintaining a 0° head position using calibrated hospital beds. This is maintained for 24 hours, including during eating, drinking, and toileting. After 24 hours, mobilization with toilet privileges may be commenced, and patients are placed in ELP for 3 hours three times daily. Treatment protocol is continued for 7 days. Patients are instructed to report any discomfort while receiving ELP. If deemed uncomfortable or potentially harmful, ELP could be interrupted, during which patients are gradually returned to a horizontal position.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Acute ischemic stroke (AIS) confirmed by cranial computed tomography (CT) or magnetic resonance (MR) imaging.
• Time from onset (symptom onset or last known well) to enrollment of ≤24 hours.
• Moderate neurological deficit (National Institutes of Health Stroke Scale \[NIHSS\] score of 6-16).
• Probable large artery atherosclerosis (LAA )etiology based on the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria (confirmed by cranial CT or MR angiography and carotid duplex ultrasonography performed on admission).
• Evidence of unilateral stenosis or occlusion of the internal carotid artery (ICA) or the M1 or proximal M2 segment of the middle cerebral artery (MCA) corresponding to the presumed culprit artery.
• Functional independence prior to stroke (modified Rankin Scale \[mRS\] score ≤1).
• Written informed consent signed by the patient or their legally authorized representative.

You may not qualify if:

• Decreased level of consciousness (NIHSS item 1a ≥1).
• Planned or completed intravenous thrombolysis and/or endovascular therapy.
• Planned carotid or intracranial revascularization within 3 months.
• Evidence of intracranial hemorrhage on neuroimaging.
• Alternative stroke etiologies (e.g., cardioembolism, non-atherosclerotic arteriopathies).
• Serious systemic illness (e.g., significant hepatic or renal insufficiency, active malignancy).
• Prior stroke with significant residual neurological deficit (mRS ≥2).
• History of intracerebral hemorrhage within the preceding 12 months.
• Any possible contraindication to ELP (e.g., active vomiting, pneumonia, uncontrolled heart failure).
• Participation in another clinical trial within the preceding 3 months.
• Pregnancy or lactation.
• Any other condition deemed inappropriate for participation by the investigators.

Sponsors & Collaborators

• Bonifacio C. Pedreogsa II: lead

Study Sites (1)

Jose R. Reyes Memorial Medical Center

Manila, NCR, 1003, Philippines

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Jose C Navarro, MD, MSc

  Jose R. Reyes Memorial Medical Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: May 1, 2025
• Primary Completion: September 19, 2025
• Study Completion: December 11, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning within 1 year after study completion (on or before December 31, 2026) and available indefinitely.
• Access Criteria: Deidentified IPD and supporting information will be made publicly available and deposited in a publicly accessible data repository without restriction.

Locations

PH (1)