Effect Of Vitalstim In Patients With Chronic Post-stroke Oropharyngeal Dysphagia "VITAL"

Completed

Phase N/A Results N/A

Update History

30 Aug '16
The Summary of Purpose was updated.
New
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.
Old
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.
A location was updated in MatarĂ³.
New
The overall status was removed for Hospital de MatarĂ³.