Feasibility Study of Biofeedback in Dysphagia Therapy Post Stroke

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Acute; Dysphagia, Oropharyngeal
• Intervention / Treatment: Behavioral: Dysphagia therapy using surface EMG as biofeedback; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Derbyshire
    • Derby, Derbyshire, United Kingdom, DE22 3NE
      • Royal Derby Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Nottingham
• Collaborators: National Institute for Health Research, United Kingdom
• Investigators: Principal Investigator: Timothy England, PhD, University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2018
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: April 13, 2018
• First Posted (Actual): April 17, 2018

Study Record Updates

• Last Update Posted (Actual): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Stroke; Deglutition Disorders
• Other Study ID Numbers: 17028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No