Dysphagia, Oropharyngeal, Stroke, Acute
Conditions
Brief summary
This study will investigate the feasibility of delivering swallowing therapy using surface electromyography as a means of biofeedback to patients with dysphagia in the acute stroke setting. It will investigate trends in efficacy by comparing biofeedback therapy to usual care. The results will inform future dosing and efficacy studies.
Interventions
BEHAVIORALDysphagia therapy using surface EMG as biofeedback
10 x 45 minute sessions over 14 days
BEHAVIORALUsual Care
Usual care may include the following Speech and Language Therapy interventions; assessment, review, therapy, patient/family education etc.. Dose will vary.
Sponsors
National Institute for Health Research, United Kingdom
University of Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomised Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* New diagnosis stroke, new dysphagia, medically stable, adequate trunk strength for videofluoroscopy.
Exclusion criteria
* Severe cognitive impairment, previous dysphagia, previous neurological condition, severe visual impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants recruited | 2 weeks | Count of number of participants can be recruited |
| Number of participants completing the treatment | 2 weeks | Count of number of participants completing the treatment |
| Average number of sessions completed | 2 weeks | Average number of sessions completed across participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in swallow physiology - timing | Pre and post 2 week intervention | Videofluoroscopy assessment to measure timing of swallow physiology |
| Quality of life | Pre and post 2 week intervention and at 90 days | Dysphagia Handicap Index |
| Change in Clinical outcomes - disability | Pre and post 2 week intervention and at 90 days. | Disability - using the Modified Rankin scale. Scale from 0-6 with higher numbers signifying increased disability |
| Change in Swallow function - severity | Pre and post 3 week intervention intervention and at 90 days | Using Dysphagia Severity Rating Scale - scale of 0-16. 0 is normal, 16 is the most severe. |
| Change in Clinical outcomes - tube status | Pre and post 2 week intervention and at 90 days. | Feeding tube status |
| Change in Clinical outcomes - mortality | Pre and post 2 week intervention and at 90 days. | Mortality |
| Change in Clinical outcomes - pneumonia | Pre and post 2 week intervention and at 90 days. | Presence of pneumonia |
| Change in Clinical outcomes - stroke severity | Pre and post 2 week intervention | Stroke severity - NIHSS. Scale from 0-42. Increased number means increase in stroke severity. |
| Change in Swallow function - intake | Pre and post 3 week intervention intervention and at 90 days | Functional Oral Intake Scale - 7 point scale from 1-7. Higher number indicated increased amount and normality of oral intake. |
| Change in Swallow physiology - PAS | Pre and post 2 week intervention | Videofluoroscopy assessment to measure swallow safety with regards to penetration/aspiration using the Penetration Aspiration Scale (PAS). 8 point scale. The higher the number the increase in penetration/aspiration. |
Countries
United Kingdom
Outcome results
None listed