Stroke Clinical Trial
Official title:
Randomized Controlled Trial To Evaluate The Effect Of Vitalstim In Patients With Chronic Post-stroke Oropharyngeal Dysphagia
Prospective, randomized, controlled, three-arm, open-label, blinded analysis. Patients
admitted with stroke diagnosis and with suspected dysphagia that meet the initial inclusion
and exclusion criteria will be consented into the clinical investigation. Patients who meet
the second set of inclusion criteria (dysphagia confirmed by VFS) will be randomized to
either active (motor or sensory) or standard treatment (control group) arms.
Subjects included in this clinical investigation will be evaluated at screening, 1-week,
3-months and at 12-months post treatment.
The main aim of the study will be to assess the effect of VitalStim therapy on improving the
safety of swallow according to the VFS, after the treatment and at 1-year follow up, on
patients with chronic post-stroke OD.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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