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Trial registered on ANZCTR

Registration number

ACTRN12612001080819

Ethics application status

Not yet submitted

Date submitted

9/10/2012

Date registered

9/10/2012

Date last updated

9/10/2012

Type of registration

Prospectively registered

Titles & IDs

Public title

The use of biofeedback in the treatment of swallowing disorders following stroke: a randomised controlled trial.

Scientific title

Is sEMG biofeedback more effective than traditional therapy alone in improving the swallowing physiology of adults post stroke?

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1135-4708

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Swallowing disorders (dysphagia)

Stroke

Condition category

Condition code

Physical Medicine / Rehabilitation

Speech therapy

Stroke

Ischaemic

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Surface electromyography biofeedback (sEMG) used in conjunction with traditional swallowing therapy:
Swallowing therapy 1) Effortful swallow: The person is instructed to swallow ‘with effort’, thereby attempting to increase the efficiency of food transfer through the pharynx.
Swallowing therapy 2) Mendelsohn Manoeuvre: The person is instructed to begin to swallow, and hold the swallow at its highest point for a few seconds, with an aim of improving the flow of food through the pharynx.
sEMG electrodes will be placed on the anterior neck. The ground electrode will be placed on the patients’ ear lobe. Muscle contraction will be measured during the swallow. This device comes with computer software, allowing the patient to ‘visualise’ the swallow on the computer.
Each participant will receive 2 half hour therapy sessions per day for 10 days (over 2 weeks).

Intervention code [1]

Rehabilitation

Comparator / control treatment

Standard treatment: Swallowing therapy
1) Effortful swallow: The person is instructed to swallow ‘with effort’, thereby attempting to increase the efficiency of food transfer through the pharynx.
Swallowing therapy

2) Mendelsohn Manoeuvre: The person is instructed to begin to swallow, and hold the swallow at its highest point for a few seconds, with an aim of improving the flow of food through the pharynx.
Each participant will receive 2 half hour therapy sessions per day for 10 days (over 2 weeks).

Control group

Active

Outcomes

Primary outcome [1]

Primary Outcome 1: Functional Oral Intake Scale score

Timepoint [1]

Timepoint: at baseline and on completion of intervention (2 weeks)

Secondary outcome [1]

Secondary Outcome 1: Penetration-Aspiration Scale score

Timepoint [1]

Timepoint: at baseline and on completion of intervention (2 weeks)

Secondary outcome [2]

Secondary Outcome 2: physiological changes of swallowing as assessed on Videofluoroscopy swallowing study

Timepoint [2]

Timepoint: at baseline and on completion of intervention

Eligibility

Key inclusion criteria

1. Adults post cortical and/or brainstem infarct
2. Demonstrated oro-pharyngeal dysphagia as diagnosed by Speech Pathologist, persisting for more than 2 weeks
3. Patients who have been identified post VFSS as appropriate for effortful swallow or mendelsohn manoeuvre rehabilitation approaches; i.e. impairment in the following scales on the Videofluoroscopic Swallowing Study rating form:
a. Pharyngeal contraction
b. Hyo-Laryngeal excursion
c. Residue in the valleculae
d. Residue in the pyriform sinuses
e. Tongue-to-palate closure
f. Crico-pharyngeal function
4. Are able to follow minimum of one stage instructions

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Adults with previous swallowing difficulty prior to the stroke
2. Adults with other diagnosed neurological disorders
3. Adults undergoing head/neck radiotherapy, due to poor skin/tissue tenderness
4. Women who are pregnant or breastfeeding (cannot participate in videofluoroscopic swallowing studies, and therefore cannot ascertain therapeutic program)

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Potential participants will be identified by the treating therapist, via clinical swallowing assessment, and a videofluoroscopic swallowing study (which are both a part of standard speech pathology swallowing management).
The information will be provided verbally, and a written patient information and consent form will also be provided. If the patient does not speak English, an interpreter will be sought. The information will initially be provided by a clinician who would normally be treating that patient. If the patient then agrees, the researcher can then provide further information, answer questions and obtain written informed consent. When consent is obtained by the researcher, the researcher will alert the person independent of the project who will provide a a sealed opaque envelope to the treating clinician – this will have details of what group the participant has been allocated to.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Due to the relatively small number of participants required for the study, ‘restricted randomisation’ will be used to ensure the group size is balanced. Computer generated randomisation sequence and sealed opaque envelopes will be prepared by someone independent of the project.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/01/2013

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

3156

Recruitment postcode(s) [2]

3128

Recruitment postcode(s) [3]

3135

Recruitment postcode(s) [4]

3151

Recruitment postcode(s) [5]

3152

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Eastern Health Research Grant Program

Address [1]

Research and University Relations
Eastern Health
Level 2
5 Arnold Street
Box Hill
Victoria 3128

Country [1]

Australia

Primary sponsor type

Individual

Name

Jennifer Paraskeva

Address

251 Mountain Hwy, Wantirna
Victoria 3152

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Lauren Speed

Address [1]

251 Mountain Hwy, Wantirna
Victoria 3152

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

24/10/2012

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The aim of this project is to evaluate the use of biofeedback as an adjunct to traditional therapies in the treatment of swallowing disorders following stroke. (biofeedback is a technique using monitoring devices to provide feedback to the patient about the swallow). 

Participants in this proposed study will have swallowing difficulties persisting for more than 2 weeks as a result of stroke. Participants will undergo a Videofluoroscopic Swallowing Study prior to the commencement of therapy, to determine an appropriate rehabilitation plan. Participants will need to be able to follow at least 1 stage instructions to participate in a therapy program. For this project, two commonly used swallowing exercises will be used. This includes the effortful swallow, which, as the name suggests, encourages the patient to use increased effort to swallow. The second therapy is ‘mendelsohn manoeuvre’, which encourages the patient to have a longer swallow. 

Patients who are suitable for either of these therapies will then be randomly assigned into two groups. In one group, patients will receive one or both of these exercises, and in the other group, they will receive one or both of these exercises in addition to biofeedback. 

Patients will receive therapy twice a day for two working weeks (20 sessions total).  After these two weeks, patients will complete another Videofluoroscopic swallowing study for comparison.  Outcomes will be measured using the Videofluoroscopic swallowing study results and rating any changes in what the patient can eat and drink. Information collected will include demographic information and stroke pathology, food and fluid texture status, and swallowing severity. This information will be collected from the patients’ medical history and outcome measure tools.

It is hypothesised that the use of surface electromyography biofeedback (sEMG) as an adjunct to traditional swallowing therapy will result in improved functional swallowing status. In particular:
1. Treatment with sEMG will decrease the time taken for patients to transition through food and/or fluid textures
2. Treatment with sEMG will result in reduced penetration and/or aspiration of food and/or fluid
3. Treatment with sEMG will result in an improvement in swallowing physiology

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Lauren Speed

Address

251 Mountain Highway Wantirna
Victoria 3152

Country

Australia

Phone

+61 3 99551291

Fax

Lauren.Speed@easternhealth.org.au

Contact person for scientific queries

Name

Lauren Speed

Address

251 Mountain Highway Wantirna
Victoria 3152

Country

Australia

Phone

+61 3 99551291

Fax

Lauren.Speed@easternhealth.org.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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