Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital de Granollers | OTHER |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Will not receive any treatment procedure. Patients allocated in the control group will be treated according to the standard clinical care of patients with dysphagia at our center, that includes: adaptation of fluids, diet and oral hygiene recommendations, and postural and swallowing maneuvers training if necessary. |
|
| Sensory Group | Experimental | Patients allocated in the sensory group will be treated with transcutaneous electrical stimulation at sensory level. In addition, they will receive the standard clinical care described in the control group. 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 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. |
|
| Motor Group | Experimental | Patients allocated in the motor group will be treated with transcutaneous electrical stimulation at motor level. In addition, they will receive the standard clinical care of patients with dysphagia described in the control group. 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard clinical care | Behavioral | adaptation of fluids, diet and oral hygiene recommendations, and postural and swallowing maneuvers training if necessary |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Penetration-Aspiration scores | baseline and Post-treatment visit (5 days) | |
| Change in Penetration-Aspiration scores | baseline and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all adverse events | 1 year | |
| Change in pharyngeal residue prevalence | Post-treatment visit (5 days) | |
| Change in pharyngeal residue prevalence |
Not provided
Inclusion Criteria:
Randomization Inclusion Criteria:
• Subject has confirmed dysphagia (PAS of 2 or more on VFS screening or pharyngeal residue).
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Mataró | Mataró | Barcelona | 08304 | Spain |
Not provided
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| transcutaneous electrical stimulation at sensory level | Device | 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. |
|
| transcutaneous electrical stimulation at motor level | Device | 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. |
|
| 1 year |
| Change in EAT-10 scores | Post-treatment visit (5 days) |
| Change in EAT-10 scores | 1 year |
| Frequency of chest infections | 1 year |
| Time from randomisation to death | 1 year |
| D010038 | Otorhinolaryngologic Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |