The effect of head position as a nonpharmacological therapy on acute ischemic stroke (AIS) remains inconclusive. Recent HOPES2 (Head dOwn-Position for acutE moderate ischemic Stroke with large artery atherosclerosis) suggest the safety, feasibility, and potential benefit of the head-down position (HDP) in acute ischemic stroke. The current study aims to investigate the efficacy and safety of HDP in acute moderate ischemic stroke patients with large artery atherosclerosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
600
-20° Trendelenburg as an adjunct to guideline-based treatment,
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China
RECRUITINGproportion of favorable functional outcome
favorable functional outcome defined as modified Rankin Score (mRS) 0-2. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Time frame: 90±7 days
proportion of excellent functional outcome
excellent functional outcome is defined as modified Rankin Score (mRS) 0-1. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Time frame: 90±7 days
ordinal distribution of modified Rankin Score (mRS)
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Time frame: 90±7 days
early neurological deterioration (END)
END is defined as more than 4-point increase in NIHSS within 48±12 hours, but was not a result of intracerebral hemorrhage
Time frame: 48±12 hours
early neurological improvement (ENI)
ENI is defined as more than 4-point decrease in NIHSS within 48±12 hours
Time frame: 48±12 hours
Changes in National Institute of Health stroke scale (NIHSS)
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
Time frame: 48±12 hours
Changes in National Institute of Health stroke scale (NIHSS)
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
Time frame: 10±2 days
changes in infarct volume
Time frame: 48±12 hours
new stroke or other vascular event(s)
Time frame: 90±7 days
all-cause mortality
Time frame: 90±7 days
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