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

NACompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

July 31, 2016

Study Completion Date

July 31, 2016

Conditions
Deglutition DisordersStroke
Interventions
BEHAVIORAL

standard clinical care

adaptation of fluids, diet and oral hygiene recommendations, and postural and swallowing maneuvers training if necessary

DEVICE

transcutaneous electrical stimulation at sensory level

The treatment procedure will consist of the application, at rest, of 80 Hz of transcutaneous electrical stimulus (biphasic, 700 µs) using VitalStim device (Chattanooga Group, Hixson, TN, USA), 2 sessions of 1 hour per day the first week, and 1 hour per day the next week. Sessions will be applied from Monday to Friday for two weeks. Treatment intensity will be set to 75% of motor threshold and electrode placement, thyro-hyoid (placement 3a described in the VitalStim Certification Program). The motor threshold will be determined by triplicate, as the intensity level at which the patient reports a grabbing or pulling sensation and confirmed by the clinician. Every 10 min, the patient will be asked if the initial sensation is maintained and, if necessary, treatment intensity will be re-adjusted.

DEVICE

transcutaneous electrical stimulation at motor level

The treatment procedure will consist of the application, at rest, of 80 Hz of transcutaneous electrical stimulus (biphasic, 700 µs) using VitalStim device (Chattanooga Group, Hixson, TN, USA), 2 sessions of 1 hour per day the first week, and 1 hour per day the next week. Sessions will be applied from Monday to Friday for two weeks. Treatment intensity will be set to the motor threshold and electrode placement, supra-hyoid. The motor threshold will be determined by triplicate, as the intensity level at which the patient reports a grabbing or pulling sensation and confirmed by the clinician. Every 10 min, the patient will be asked if the initial sensation is maintained and, if necessary, treatment intensity will be re-adjusted.

Trial Locations (1)

08304

Hospital de Mataró, Mataró

All Listed Sponsors
collaborator

Hospital de Granollers

OTHER

lead

Pere Clave

OTHER

NCT02379182 - Effect Of Vitalstim In Patients With Chronic Post-stroke Oropharyngeal Dysphagia | Biotech Hunter | Biotech Hunter