This is a small, pilot randomized clinical trial of administering sildenafil citrate to individuals within 10 days of ischemic stroke who have motor impairment and who are undergoing inpatient rehabilitation compared to placebo. The primary outcome is motor recovery at one and three months.
Individuals who are within 4-10 days post ischemic stroke with arm hemiparesis or hemiplegia who are admitted to inpatient rehabilitation are randomized to receive either sildenafil citrate (25 mg once per day) or placebo for 14 days. These individuals receive usual rehabilitation and medical care. Primary outcomes are motor skills and walking speed at one and three months. If willing and able, participants undergo an MRI to measure the integrity of the white matter pathways in the motor system using diffusion tensor imaging. Repeat MRIs are obtained at one and three months. The investigators will examine if such white matter integrity predicts response to the drug and if the drug facilitates changes in white matter.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
11
University of Utah
Salt Lake City, Utah, United States
Fugl-Meyer Motor Assessment
An assessment of upper extremity and lower extremity motor impairment
Time frame: change from baseline at 1 month
Fugl-Meyer Assessment
An assessment of upper extremity and lower extremity motor impairment
Time frame: change from baseline at 3 months
10 meter walk
an assessment of usual gait speed
Time frame: change from baseline at one month
Wolf Motor Function Test
An assessment of motor function
Time frame: baseline, one month, three months
Motor Activity Log
A self-report of paretic arm (frequency and perceived ability) use in every day activities
Time frame: one month
Stroke Impact Scale
A self-report measure of the impact of stroke on the individual for body functions, activities, and participation
Time frame: one month
10 meter walk
an assessment of usual gait speed
Time frame: change from baseline at 3 months
Wolf Motor Function Test
An assessment of motor function
Time frame: change from baseline at 3 months
Motor Activity Log
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A self-report of paretic arm (frequency and perceived ability) use in every day
Time frame: 3 months
Stroke Impact Scale
A self-report measure of the impact of stroke on the individual for body
Time frame: 3 months