Feasibility Study of Biofeedback in Dysphagia Therapy Post Stroke

Overview

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.

Full Title of Study: “A Randomised Controlled Feasibility Trial of Dysphagia Therapy Using Biofeedback in Patients With Acute Stroke”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: March 2020

Interventions

  • Behavioral: Dysphagia therapy using surface EMG as biofeedback
    • 10 x 45 minute sessions over 14 days
  • Behavioral: Usual Care
    • Usual care may include the following Speech and Language Therapy interventions; assessment, review, therapy, patient/family education etc.. Dose will vary.

Arms, Groups and Cohorts

  • 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.
  • Other: Control group
    • This group will receive usual care provided by Speech and Language Therapists, which may involve assessment, review, therapy, patient/family education

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants recruited
    • Time Frame: 2 weeks
    • Count of number of participants can be recruited
  • Number of participants completing the treatment
    • Time Frame: 2 weeks
    • Count of number of participants completing the treatment
  • Average number of sessions completed
    • Time Frame: 2 weeks
    • Average number of sessions completed across participants.

Secondary Measures

  • Change in Swallow function – severity
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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 swallow physiology – timing
    • Time Frame: Pre and post 2 week intervention
    • Videofluoroscopy assessment to measure timing of swallow physiology
  • Quality of life
    • Time Frame: Pre and post 2 week intervention and at 90 days
    • Dysphagia Handicap Index
  • Change in Clinical outcomes – disability
    • Time Frame: 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 Clinical outcomes – stroke severity
    • Time Frame: Pre and post 2 week intervention
    • Stroke severity – NIHSS. Scale from 0-42. Increased number means increase in stroke severity.
  • Change in Clinical outcomes – tube status
    • Time Frame: Pre and post 2 week intervention and at 90 days.
    • Feeding tube status
  • Change in Clinical outcomes – mortality
    • Time Frame: Pre and post 2 week intervention and at 90 days.
    • Mortality
  • Change in Clinical outcomes – pneumonia
    • Time Frame: Pre and post 2 week intervention and at 90 days.
    • Presence of pneumonia

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Nottingham
  • Collaborator
    • National Institute for Health Research, United Kingdom
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Timothy England, PhD, Principal Investigator, University of Nottingham
  • Overall Contact(s)
    • Jacqueline Benfield, 00441332785891, mzxjkb@nottingham.ac.uk

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