Stroke, Ischemic
Conditions
Keywords
Dysphagia, Swallow, Stimulation
Brief summary
Dysphagia is a serious cause of morbidity and mortality in stroke survivors. Electrical stimulation is often included as part of the treatment plan for dysphagia, and can be applied at a sensory or motor level intensity. However, evidence to support these different modes of stimulation is lacking. This study compared the effectiveness of sensory and motor level stimulation on post-stroke dysphagia.
Detailed description
Objective: Dysphagia is a serious cause of morbidity and mortality in stroke survivors. Electrical stimulation is often included as part of the treatment plan for dysphagia, and can be applied at a sensory or motor level intensity. However, evidence to support sensory versus motor stimulation is lacking. This study compares the effect of sensory and motor stimulation on post-stroke dysphagia. Design: Randomized controlled trial Setting: Inpatient rehabilitation facility. Participants: Participants (50-75 years of age) who had dysphagia caused by a stroke within 6 months prior to enrollment were included. Participants were excluded if they had a contraindication for electrical stimulation, previous stroke, psychiatric disorder, contraindications for MBS, or pre-stroke swallowing disorders. Interventions: Each patient received ten, 45-minute anterior neck sensory or motor level electrical stimulation sessions in addition to standard speech therapy. Motor stimulation was administered as a stimulus intensity sufficient to produce muscle contractions. Sensory stimulation was defined as the threshold when the patient feels a tingling sensation on their skin (approximately 4-5mA). Main Outcome Measures: Swallow FIM, National Outcome Measurement System (NOMS), Dysphagia Outcome Severity Scale (DOSS), and change in modified diet.
Interventions
DEVICENeuromuscular electrical stimulation
Motor stimulation was administered at an intensity sufficient to produce muscle contractions. Sensory stimulation was defined as the threshold when the patient feels a tingling sensation on their skin.
Sponsors
Casa Colina Hospital and Centers for Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind
Intervention model description
Randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18-80 * acute ischemic CVA within the first month and confirmed by MRI. * Diagnosis of dysphagia will be obtained by bedside swallowing exam and MBS/FEES studies.
Exclusion criteria
* patients who have contraindications for electrical stimulation (malignancy, DVT/thrombophlebitis, hemorrhagic conditions, pregnancy, pacemaker or other electrical hardware) * known premorbid swallowing disorders * GERD * dementia or psychiatric disorder * bilateral cerebral involvement * contraindications for FEES/MBS (infectious disease such as HIV, HCV, HBV, nasal obstruction, decompensated heart disease, risk of bleeding such as active ulcers, allergy to contrast).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Swallow Functional Assessment Measure | up to 2 months | 7 point swallow scale the Functional oral intake scale (FOIS) lowest score = 1; highest = 7. |
| Change in Dysphagia outcome Severity Scale | up to 2 months | seven-point functional outcome scale designed to assess dysphagia severity on the MBSS, lowest score = 1; highest = 7. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PenAsp | up to 2 months | Evaluates the depth response and clearance of material entering into the airway, lowest score = 8; highest =1. |
| Change in Swal-Qol | up to 3 months | 93-item outcome tool 24 was used to determine impact on quality-of-life and quality-of-care. Each item has a 5 point likert scale. |
Countries
United States
Outcome results
None listed