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Feasibility Study of Biofeedback in Dysphagia Therapy Post Stroke

Primary Purpose

Stroke, Acute, Dysphagia, Oropharyngeal

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Dysphagia therapy using surface EMG as biofeedback
Usual Care
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Derby Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Biofeedback group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Number of participants recruited
Count of number of participants can be recruited
Number of participants completing the treatment
Count of number of participants completing the treatment
Average number of sessions completed
Average number of sessions completed across participants.

Secondary Outcome Measures

Change in Swallow function - severity
Using Dysphagia Severity Rating Scale - scale of 0-16. 0 is normal, 16 is the most severe.
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.
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.
Change in swallow physiology - timing
Videofluoroscopy assessment to measure timing of swallow physiology
Quality of life
Dysphagia Handicap Index
Change in Clinical outcomes - disability
Disability - using the Modified Rankin scale. Scale from 0-6 with higher numbers signifying increased disability
Change in Clinical outcomes - stroke severity
Stroke severity - NIHSS. Scale from 0-42. Increased number means increase in stroke severity.
Change in Clinical outcomes - tube status
Feeding tube status
Change in Clinical outcomes - mortality
Mortality
Change in Clinical outcomes - pneumonia
Presence of pneumonia

Full Information

First Posted
November 29, 2017
Last Updated
October 28, 2020
Sponsor
University of Nottingham
Collaborators
National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT03499574
Brief Title
Feasibility Study of Biofeedback in Dysphagia Therapy Post Stroke
Official Title
A Randomised Controlled Feasibility Trial of Dysphagia Therapy Using Biofeedback in Patients With Acute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 26, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
National Institute for Health Research, United Kingdom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Dysphagia, Oropharyngeal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Controlled Trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biofeedback group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
This group will receive usual care provided by Speech and Language Therapists, which may involve assessment, review, therapy, patient/family education
Intervention Type
Behavioral
Intervention Name(s)
Dysphagia therapy using surface EMG as biofeedback
Other Intervention Name(s)
Biofeedback
Intervention Description
10 x 45 minute sessions over 14 days
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Usual care may include the following Speech and Language Therapy interventions; assessment, review, therapy, patient/family education etc.. Dose will vary.
Primary Outcome Measure Information:
Title
Number of participants recruited
Description
Count of number of participants can be recruited
Time Frame
2 weeks
Title
Number of participants completing the treatment
Description
Count of number of participants completing the treatment
Time Frame
2 weeks
Title
Average number of sessions completed
Description
Average number of sessions completed across participants.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Change in Swallow function - severity
Description
Using Dysphagia Severity Rating Scale - scale of 0-16. 0 is normal, 16 is the most severe.
Time Frame
Pre and post 3 week intervention intervention and at 90 days
Title
Change in Swallow function - intake
Description
Functional Oral Intake Scale - 7 point scale from 1-7. Higher number indicated increased amount and normality of oral intake.
Time Frame
Pre and post 3 week intervention intervention and at 90 days
Title
Change in Swallow physiology - PAS
Description
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.
Time Frame
Pre and post 2 week intervention
Title
Change in swallow physiology - timing
Description
Videofluoroscopy assessment to measure timing of swallow physiology
Time Frame
Pre and post 2 week intervention
Title
Quality of life
Description
Dysphagia Handicap Index
Time Frame
Pre and post 2 week intervention and at 90 days
Title
Change in Clinical outcomes - disability
Description
Disability - using the Modified Rankin scale. Scale from 0-6 with higher numbers signifying increased disability
Time Frame
Pre and post 2 week intervention and at 90 days.
Title
Change in Clinical outcomes - stroke severity
Description
Stroke severity - NIHSS. Scale from 0-42. Increased number means increase in stroke severity.
Time Frame
Pre and post 2 week intervention
Title
Change in Clinical outcomes - tube status
Description
Feeding tube status
Time Frame
Pre and post 2 week intervention and at 90 days.
Title
Change in Clinical outcomes - mortality
Description
Mortality
Time Frame
Pre and post 2 week intervention and at 90 days.
Title
Change in Clinical outcomes - pneumonia
Description
Presence of pneumonia
Time Frame
Pre and post 2 week intervention and at 90 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy England, PhD
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Derby Hospital
City
Derby
State/Province
Derbyshire
ZIP/Postal Code
DE22 3NE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility Study of Biofeedback in Dysphagia Therapy Post Stroke

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