Feasibility Study of Biofeedback in Dysphagia Therapy Post Stroke

University of Nottingham27 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke, Acute Dysphagia, Oropharyngeal

Interventions

Dysphagia therapy using surface EMG as biofeedbackBEHAVIORAL

10 x 45 minute sessions over 14 days

Usual CareBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Royal Derby Hospital

Derby, Derbyshire, United Kingdom

Outcomes

Primary Outcomes

Number of participants recruited

Count of number of participants can be recruited

Time frame: 2 weeks

Number of participants completing the treatment

Count of number of participants completing the treatment

Time frame: 2 weeks

Average number of sessions completed

Average number of sessions completed across participants.

Time frame: 2 weeks

Secondary Outcomes

Change in Swallow function - severity

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

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.

Time frame: Pre and post 3 week intervention intervention and at 90 days

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.

Time frame: Pre and post 2 week intervention

Change in swallow physiology - timing

Videofluoroscopy assessment to measure timing of swallow physiology

Time frame: Pre and post 2 week intervention

Data from ClinicalTrials.gov

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