Acute Ischemic StrokeLEG-UPNCT07483580
LEG-UP Feasibility Study: Elevated Leg Positioning For Acute Moderate Ischemic Stroke
A study testing Elevated Leg Positioning in people with Acute Ischemic Stroke, run by Bonifacio C. Pedreogsa II at 1 site in Philippines.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Elevated Leg Positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 May 2025to 11 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Elevated Leg Positioning For Acute Moderate Ischemic Stroke: The LEG-UP Randomized Feasibility Study
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.
Read the 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
- Being tested
- Elevated Leg Positioning
- Keywords
- acute ischemic stroke, patient positioning, leg elevation, large artery atherosclerosis, feasibility study
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elevated Leg PositioningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to the end of treatment at 7 days.
Secondary outcomes (4)
Number of Participants With Early Neurologic Deterioration (END)
Early neurologic deterioration (END), defined as an increase of ≥4 points in the National Institutes of Health Stroke Scale (NIHSS) score within 48 hours not attributable to intracranial hemorrhage.
The NIHSS is a clinician-administered scale used to quantify neurologic deficit in stroke, with scores ranging from 0 to 42, where higher scores indicate more severe neurologic impairment.
Measured: Within 48 hours after randomization.
Change from Baseline in the National Institutes of Health Stroke Scale (NIHSS) Score at Day 7
Change in National Institutes of Health Stroke Scale (NIHSS) score at day 7 compared with baseline.
The NIHSS is a clinician-administered scale used to quantify neurologic deficit in stroke, with scores ranging from 0 to 42, where higher scores indicate more severe neurologic impairment.
Measured: Baseline and day 7 after randomization.
Number of Participants With All-Cause Mortality at 30 Days
All-cause mortality at 30 days.
Measured: 30 days after randomization.
Number of Participants With Favorable Functional Outcome at 90 Days
Favorable functional outcome at 90 days, defined as a modified Rankin Scale (mRS) score of 0-2. The mRS is a measure of functional disability ranging from 0 to 6, where 0 indicates no symptoms and 6 indicates death.
Measured: 90 days after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 May 2025
- Primary completion19 Sep 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bonifacio C. Pedreogsa II
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Bonifacio C. Pedreogsa II, Jose R. Reyes Memorial Medical Center
- Investigators
- Jose C Navarro, MD, MSc, Study chair, Jose R. Reyes Memorial Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483580
- Sponsor's protocol ID
- JRRMMC IRB No. 2024-279
- Acronym
- LEG-UP
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elevated Leg Positioning For Acute Moderate Ischemic Stroke: The LEG-UP Randomized Feasibility Study
- ClinicalTrials.gov ID
- NCT07483580
- Acronym / sponsor ID
- LEG-UP / JRRMMC IRB No. 2024-279
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute ischemic stroke, patient positioning, leg elevation, large artery atherosclerosis, feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bonifacio C. Pedreogsa IIOther government
- Study start
- 1 May 2025 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Elevated Leg PositioningIn 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elevated Leg PositioningElevated 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. | Other | Intervention |
Primary outcome
Proportion of Participants Adhering to the Assigned Elevated Leg Positioning (ELP) Intervention per Protocol
Time frame: From enrollment to the end of treatment at 7 days.
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.
Number of Participants With Prespecified Adverse Events During the Treatment Period
Time frame: From enrollment to the end of treatment at 7 days.
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.
4 secondary outcomes
Number of Participants With Early Neurologic Deterioration (END)
Time frame: Within 48 hours after randomization.
Change from Baseline in the National Institutes of Health Stroke Scale (NIHSS) Score at Day 7
Time frame: Baseline and day 7 after randomization.
Number of Participants With All-Cause Mortality at 30 Days
Time frame: 30 days after randomization.
Number of Participants With Favorable Functional Outcome at 90 Days
Time frame: 90 days after randomization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: Yes. All de-identified IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose C Navarro, MD, MSc study chair
Jose R. Reyes Memorial Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elevated Leg Positioning in people with Acute Ischemic Stroke, run by Bonifacio C. Pedreogsa II at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Adhering to the Assigned Elevated Leg Positioning (ELP) Intervention per Protocol (time frame: From enrollment to the end of treatment at 7 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.