Status: Not yet recruiting
Keywords: stroke , rehabilitation , motor skills , sildenafil
IRB Number: 00053515
Specialty: Occupational Therapy, Physical Therapy, Physical Medicine and Rehabilitation, Physical Medicine and Rehabilitation
Sub Specialties: Stroke ,
The aim of this study is to determine safety, feasibility and effect on stroke recovery of administering sildenafil to participants with acute stroke. We expect that we will be able to recruit our target number of participants, demonstrate that it is feasible to retain them in the study without serious adverse effects related to the study or side effects uncomfortable enough to cause them to drop out of the study, and that we will be able to calculate a valid effect size for each group.
An additional purpose of this study is to examine the brain white matter and activation changes in the motor system following this therapy in order to delineate neural mechanisms of stroke recovery associated with this therapy.
A double blind randomized, controlled trial will be used. Participants will be randomized to receive 25mg of sildenafil or placebo the day after baseline testing is completed, but no later than day 11 post-stroke and will continue for the next 14 days. They will continue with usual rehabilitation. The occupational and physical therapists providing rehabilitation will record the content of each therapy session. Participants will be tested for upper extremity and lower extremity motor function at baseline, and then every week during inpatient rehabilitation. They will be retested at 1 month and at 3 months following inpatient rehabilitation. The amount and type of therapy they receive during this follow-up period will also be monitored.