NCT03499574

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 26, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

2.2 years

First QC Date

November 29, 2017

Last Update Submit

October 28, 2020

Conditions

Stroke, AcuteDysphagia, Oropharyngeal

Outcome Measures

Primary Outcomes (3)

  • Number of participants recruited

    Count of number of participants can be recruited

    2 weeks

  • Number of participants completing the treatment

    Count of number of participants completing the treatment

    2 weeks

  • Average number of sessions completed

    Average number of sessions completed across participants.

    2 weeks

Secondary Outcomes (10)

  • Change in Swallow function - severity

    Pre and post 3 week intervention intervention and at 90 days

  • Change in Swallow function - intake

    Pre and post 3 week intervention intervention and at 90 days

  • Change in Swallow physiology - PAS

    Pre and post 2 week intervention

  • Change in swallow physiology - timing

    Pre and post 2 week intervention

  • Quality of life

    Pre and post 2 week intervention and at 90 days

  • +5 more secondary outcomes

Study Arms (2)

Biofeedback group

EXPERIMENTAL

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 biofeedbackBehavioral: Usual Care

Control group

OTHER

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

Behavioral: Usual Care

Interventions

Dysphagia therapy using surface EMG as biofeedbackBEHAVIORAL

10 x 45 minute sessions over 14 days

Also known as: Biofeedback
Biofeedback group
Usual CareBEHAVIORAL

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

Biofeedback groupControl group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • New diagnosis stroke, new dysphagia, medically stable, adequate trunk strength for videofluoroscopy.

You may not qualify if:

  • Severe cognitive impairment, previous dysphagia, previous neurological condition, severe visual impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Derby Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

Location

MeSH Terms

Conditions

StrokeDeglutition Disorders

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Timothy England, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2017

First Posted

April 17, 2018

Study Start

January 26, 2018

Primary Completion

March 31, 2020

Study Completion

May 31, 2020

Last Updated

October 29, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)