An interventional study of Dysphagia therapy using surface EMG as biofeedback and Usual Care in Stroke, Acute and Dysphagia, Oropharyngeal, sponsored by University of Nottingham. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-29.
Sponsored by University of Nottingham · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Dysphagia therapy using surface EMG as biofeedback - 10 x 45 minute sessions of swallow strength and skill training using surface electromyography as biofeedback tool. This group will also receive usual care provided by Speech and Language Therapists, which may involve assessment, review, therapy, patient/family education.
Behavioral: Dysphagia therapy using surface EMG as biofeedback · Behavioral: Usual Care
This group will receive usual care provided by Speech and Language Therapists, which may involve assessment, review, therapy, patient/family education
Behavioral: Usual Care
10 x 45 minute sessions over 14 days
Also known as: Biofeedback
Usual care may include the following Speech and Language Therapy interventions; assessment, review, therapy, patient/family education etc.. Dose will vary.
Number of participants recruited
Count of number of participants can be recruited
Time frame: 2 weeks
Number of participants completing the treatment
Count of number of participants completing the treatment
Time frame: 2 weeks
Average number of sessions completed
Average number of sessions completed across participants.
Time frame: 2 weeks
Change in Swallow function - severity
Using Dysphagia Severity Rating Scale - scale of 0-16. 0 is normal, 16 is the most severe.
Time frame: Pre and post 3 week intervention intervention and at 90 days
Change in Swallow function - intake
Functional Oral Intake Scale - 7 point scale from 1-7. Higher number indicated increased amount and normality of oral intake.
Time frame: Pre and post 3 week intervention intervention and at 90 days
Change in Swallow physiology - PAS
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.
Time frame: Pre and post 2 week intervention
Change in swallow physiology - timing
Videofluoroscopy assessment to measure timing of swallow physiology
Time frame: Pre and post 2 week intervention
Quality of life
Dysphagia Handicap Index
Time frame: Pre and post 2 week intervention and at 90 days
Change in Clinical outcomes - disability
Disability - using the Modified Rankin scale. Scale from 0-6 with higher numbers signifying increased disability
Time frame: Pre and post 2 week intervention and at 90 days.
Change in Clinical outcomes - stroke severity
Stroke severity - NIHSS. Scale from 0-42. Increased number means increase in stroke severity.
Time frame: Pre and post 2 week intervention
Change in Clinical outcomes - tube status
Feeding tube status
Time frame: Pre and post 2 week intervention and at 90 days.
Change in Clinical outcomes - mortality
Mortality
Time frame: Pre and post 2 week intervention and at 90 days.
Change in Clinical outcomes - pneumonia
Presence of pneumonia
Time frame: Pre and post 2 week intervention and at 90 days.
Plan to share: No
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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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University of Nottingham