Feasibility Study of Biofeedback in Dysphagia Therapy Post Stroke

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised Controlled Feasibility Trial of Dysphagia Therapy Using Biofeedback in Patients With Acute Stroke

Conditions
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Stroke, Acute, Dysphagia, Oropharyngeal

Intervention / Treatment
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* Behavioral: Dysphagia therapy using surface EMG as biofeedback
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biofeedback group<br>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<br>* 10 x 45 minute sessions over 14 days<br>* Other names: Biofeedback;Behavioral: Usual Care<br>* Usual care may include the following Speech and Language Therapy interventions; assessment, review, therapy, patient/family education etc.. Dose will vary.<br>|
| Other: Control group<br>This group will receive usual care provided by Speech and Language Therapists, which may involve assessment, review, therapy, patient/family education | Behavioral: Usual Care<br>* Usual care may include the following Speech and Language Therapy interventions; assessment, review, therapy, patient/family education etc.. Dose will vary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants recruited | Count of number of participants can be recruited | 2 weeks | 
| Number of participants completing the treatment | Count of number of participants completing the treatment | 2 weeks | 
| Average number of sessions completed | Average number of sessions completed across participants. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Swallow function - severity | Using Dysphagia Severity Rating Scale - scale of 0-16. 0 is normal, 16 is the most severe. | 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. | 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. | Pre and post 2 week intervention | 
| Change in swallow physiology - timing | Videofluoroscopy assessment to measure timing of swallow physiology | Pre and post 2 week intervention | 
| Quality of life | Dysphagia Handicap Index | 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 | 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. | Pre and post 2 week intervention | 
| Change in Clinical outcomes - tube status | Feeding tube status | Pre and post 2 week intervention and at 90 days. | 
| Change in Clinical outcomes - mortality | Mortality | Pre and post 2 week intervention and at 90 days. | 
| Change in Clinical outcomes - pneumonia | Presence of pneumonia | Pre and post 2 week intervention and at 90 days. |