Topic: Stroke Research Network
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Swallowing difficulty which is due to stroke (symptoms should include reduced laryngeal elevation, as determined by videofluoroscopy) 2. These difficulties should have persisted for = 1 month (in order to control for spontaneous recovery and response to usual care) 3. Medical stability 4. Absence of any other neurological disease 5. Availability to participate in a treatment session each weekday (either at home or in clinic) for a 4-week period
Exclusion criteria
Exclusion criteria: 1. Under 18 years of age 2. Have an implanted electronic device e.g. pacemaker 3. Have moderate/severe cognitive or communication difficulties (as they may be unable to give informed consent, or struggle to understand and comply with treatment instructions) 4. Present with progressive disease 5. Are pregnant 6. Have active cancerous lesions or infections in the treatment site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Swallowing function, measured by: 1.1. MASA - Mann Assessment of Swallowing Ability (validated tool to give a numerical score of patients? swallowing ability) 1.2. FOIS - Functional Oral Intake Scale (well used and psychometrically validated tool to measure change in functional eating abilities of Stroke patients over time) 1.3. Rosenbek PAS - Penetration-Aspiration Scale (validated tool for use during videofluoroscopy to evaluate the presence and severity of aspiration i.e. penetration of food and/or fluid into the airway below the level of the vocal folds) 1.4. SWAL-QOL - Patients' assessment of dysphagia related quality of life (validated tool to allow patients to rate 10 dysphagia related quality of life concepts) 2. Patients will also be asked to rate the tolerability of the treatment. Information on the safety of the treatment protocol will be evaluated by recording of any adverse effects during the study Timepoint(s): 4 weeks following start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom