Feasibility Study of Biofeedback in Dysphagia Therapy Post Stroke

Stroke, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03499574
• Other study ID #: 17028
• Status: Completed
• Phase: N/A
• Start date: January 26, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: October 2020
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia, Oropharyngeal
• Stroke
• Stroke, Acute

Intervention

Behavioral:
• Dysphagia therapy using surface EMG as biofeedback
10 x 45 minute sessions over 14 days
• Usual Care
Usual care may include the following Speech and Language Therapy interventions; assessment, review, therapy, patient/family education etc.. Dose will vary.

Locations

Country	Name	City	State
United Kingdom	Royal Derby Hospital	Derby	Derbyshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants recruited	Count of number of participants can be recruited	2 weeks
Primary	Number of participants completing the treatment	Count of number of participants completing the treatment	2 weeks
Primary	Average number of sessions completed	Average number of sessions completed across participants.	2 weeks
Secondary	Change in Swallow function - severity	Using Dysphagia Severity Rating Scale - scale of 0-16. 0 is normal, 16 is the most severe.	Pre and post 3 week intervention intervention and at 90 days
Secondary	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.	Pre and post 3 week intervention intervention and at 90 days
Secondary	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.	Pre and post 2 week intervention
Secondary	Change in swallow physiology - timing	Videofluoroscopy assessment to measure timing of swallow physiology	Pre and post 2 week intervention
Secondary	Quality of life	Dysphagia Handicap Index	Pre and post 2 week intervention and at 90 days
Secondary	Change in Clinical outcomes - disability	Disability - using the Modified Rankin scale. Scale from 0-6 with higher numbers signifying increased disability	Pre and post 2 week intervention and at 90 days.
Secondary	Change in Clinical outcomes - stroke severity	Stroke severity - NIHSS. Scale from 0-42. Increased number means increase in stroke severity.	Pre and post 2 week intervention
Secondary	Change in Clinical outcomes - tube status	Feeding tube status	Pre and post 2 week intervention and at 90 days.
Secondary	Change in Clinical outcomes - mortality	Mortality	Pre and post 2 week intervention and at 90 days.
Secondary	Change in Clinical outcomes - pneumonia	Presence of pneumonia	Pre and post 2 week intervention and at 90 days.