Skip to main content
OpenTrials
Completed

NCT Number: NCT03499574

Feasibility Study of Biofeedback in Dysphagia Therapy Post 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Dysphagia, Oropharyngeal Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Derby Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dysphagia therapy using surface EMG as biofeedback

Behavioral

10 x 45 minute sessions over 14 days

Other names: Biofeedback

Usual Care

Behavioral

Usual care may include the following Speech and Language Therapy interventions; assessment, review, therapy, patient/family education etc.. Dose will vary.

Primary outcomes

  1. Number of participants recruited

    Time frame: 2 weeks

    Count of number of participants can be recruited

  2. Number of participants completing the treatment

    Time frame: 2 weeks

    Count of number of participants completing the treatment

  3. Average number of sessions completed

    Time frame: 2 weeks

    Average number of sessions completed across participants.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Change in swallow physiology - timing

    Time frame: Pre and post 2 week intervention

    Videofluoroscopy assessment to measure timing of swallow physiology

  5. Quality of life

    Time frame: Pre and post 2 week intervention and at 90 days

    Dysphagia Handicap Index

  6. 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

  7. 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.

  8. Change in Clinical outcomes - tube status

    Time frame: Pre and post 2 week intervention and at 90 days.

    Feeding tube status

  9. Change in Clinical outcomes - mortality

    Time frame: Pre and post 2 week intervention and at 90 days.

    Mortality

  10. Change in Clinical outcomes - pneumonia

    Time frame: Pre and post 2 week intervention and at 90 days.

    Presence of pneumonia

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 17, 2018
Registry last updated
Oct 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.