NCT07483580

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Bonifacio C. Pedreogsa II · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The acute phase of ischemic stroke is a potentially reversible process wherein the extent of tissue injury is dependent on the severity and duration of the perfusion deficit, which are strongly influenced by the adequacy of collateral circulation and the timing of arterial blood flow restoration relative to the window of cellular viability. In addition to pharmacologic and mechanical reperfusion therapies, measures that augment perfusion to the salvageable ischemic penumbra may mitigate subsequent infarct progression and associated neurological deficits. Accordingly, patient positioning strategies intended to enhance cerebral perfusion and oxygenation during the early management of acute ischemic stroke (AIS) may offer a simple and cost-effective nonpharmacologic approach to improve outcomes. Two strategies, the 0° and lower head (-20° Trendelenburg) positions, have been evaluated in randomized clinical trials but have yielded inconclusive findings. This study proposes elevated leg positioning (ELP) while maintaining a 0° head position as a physiologically plausible hemodynamic intervention to optimize penumbral perfusion. In theory, this position would increase venous return and preload, thereby augmenting cardiac output while simultaneously minimizing the hydrostatic pressure gradient between the heart and brain, resulting in increased cerebral perfusion pressure and improved collateral circulation. This may be particularly relevant in the setting of an acute ischemic insult, where focal impairment of cerebrovascular autoregulation may render cerebral blood flow to the penumbra increasingly pressure-passive and dependent on systemic hemodynamics. Furthermore, compared with lower head positioning strategies, maintenance of a neutral head and airway position may confer safety and tolerability advantages. The present study was designed to assess the feasibility and safety of ELP initiated within 24 hours of symptom onset or last known well in patients with moderate anterior circulation ischemic stroke with probable large artery atherosclerosis (LAA) etiology, and to generate preliminary estimates of effect sizes to inform the design and sample size calculation of a future definitive randomized trial.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
OTHER	Elevated Leg Positioning	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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-09-19
• Completion: 2025-12-11
• First posted: 2026-03-19
• Last updated: 2026-03-24

Locations

1 site across 1 country: Philippines