Feasibility Study of Biofeedback in Dysphagia Therapy Post Stroke

NCT ID: NCT03499574

Last Updated: 2020-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-26

Study Completion Date

2020-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke, Acute Dysphagia, Oropharyngeal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Dysphagia therapy using surface EMG as biofeedback

Intervention Type BEHAVIORAL

10 x 45 minute sessions over 14 days

Usual Care

Intervention Type BEHAVIORAL

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

Group Type OTHER

Usual Care

Intervention Type BEHAVIORAL

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

Interventions

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Dysphagia therapy using surface EMG as biofeedback

10 x 45 minute sessions over 14 days

Intervention Type BEHAVIORAL

Usual Care

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Biofeedback

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy England, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

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Royal Derby Hospital

Derby, Derbyshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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17028

Identifier Type: -

Identifier Source: org_study_id