Feasibility Study of Biofeedback in Dysphagia Therapy Post Stroke

Not Applicable

Completed

• Conditions: Stroke, Acute; Dysphagia, Oropharyngeal
• Interventions: Behavioral: Dysphagia therapy using surface EMG as biofeedback; Behavioral: Usual Care

• Registration Number: NCT03499574
• Lead Sponsor: University of Nottingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-29
• Study Start: 2018-01-26
• Study First Submitted QC: 2018-04-13
• Study First Posted: 2018-04-17
• Primary Completion: 2020-03-31
• Study Completion: 2020-05-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-28
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofeedback group	Dysphagia therapy using surface EMG as biofeedback	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.
Control group	Usual Care	This group will receive usual care provided by Speech and Language Therapists, which may involve assessment, review, therapy, patient/family education
Biofeedback group	Usual Care	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.

Primary Outcome Measures

Name	Time	Method
Average number of sessions completed	2 weeks	Average number of sessions completed across participants.
Number of participants completing the treatment	2 weeks	Count of number of participants completing the treatment
Number of participants recruited	2 weeks	Count of number of participants can be recruited

Secondary Outcome Measures

Name	Time	Method
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 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.
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 Clinical outcomes - mortality	Pre and post 2 week intervention and at 90 days.	Mortality
Change in Clinical outcomes - tube status	Pre and post 2 week intervention and at 90 days.	Feeding tube status
Change in Clinical outcomes - pneumonia	Pre and post 2 week intervention and at 90 days.	Presence of pneumonia

Trial Locations

Locations (1)

Royal Derby Hospital; 🇬🇧 Derby, Derbyshire, United Kingdom