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Feasibility Study of Biofeedback in Dysphagia Therapy Post Stroke

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ClinicalTrials.gov Identifier: NCT03499574
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : May 20, 2019
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stroke, Acute Dysphagia, Oropharyngeal Behavioral: Dysphagia therapy using surface EMG as biofeedback Behavioral: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised Controlled Trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Feasibility Trial of Dysphagia Therapy Using Biofeedback in Patients With Acute Stroke
Actual Study Start Date : January 26, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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 Name: 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.

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499574


Contacts
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Contact: Jacqueline Benfield 00441332785891 mzxjkb@nottingham.ac.uk
Contact: Timothy England, PhD 00441332724668 timothy.england@nottingham.ac.uk

Locations
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United Kingdom
Royal Derby Hospital Recruiting
Derby, Derbyshire, United Kingdom, DE22 3NE
Contact: Jacqueline Benfield       mzxjkb@nottingham.ac.uk   
Sponsors and Collaborators
University of Nottingham
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Timothy England, PhD University of Nottingham

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03499574    
Other Study ID Numbers: 17028
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Deglutition Disorders
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases