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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] 281362 0
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) 287586 0
Stroke 287589 0
Condition category
Condition code
Physical Medicine / Rehabilitation 287911 287911 0 0
Speech therapy
Stroke 287914 287914 0 0
Ischaemic
Oral and Gastrointestinal 287915 287915 0 0
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] 285824 0
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] 288128 0
Primary Outcome 1: Functional Oral Intake Scale score
Timepoint [1] 288128 0
Timepoint: at baseline and on completion of intervention (2 weeks)
Secondary outcome [1] 299462 0
Secondary Outcome 1: Penetration-Aspiration Scale score
Timepoint [1] 299462 0
Timepoint: at baseline and on completion of intervention (2 weeks)
Secondary outcome [2] 299463 0
Secondary Outcome 2: physiological changes of swallowing as assessed on Videofluoroscopy swallowing study
Timepoint [2] 299463 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
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] 5815 0
3156
Recruitment postcode(s) [2] 5816 0
3128
Recruitment postcode(s) [3] 5817 0
3135
Recruitment postcode(s) [4] 5818 0
3151
Recruitment postcode(s) [5] 5819 0
3152

Funding & Sponsors
Funding source category [1] 286118 0
Hospital
Name [1] 286118 0
Eastern Health Research Grant Program
Address [1] 286118 0
Research and University Relations
Eastern Health
Level 2
5 Arnold Street
Box Hill
Victoria 3128
Country [1] 286118 0
Australia
Primary sponsor type
Individual
Name
Jennifer Paraskeva
Address
251 Mountain Hwy, Wantirna
Victoria 3152
Country
Australia
Secondary sponsor category [1] 284931 0
Individual
Name [1] 284931 0
Lauren Speed
Address [1] 284931 0
251 Mountain Hwy, Wantirna
Victoria 3152
Country [1] 284931 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288165 0
Ethics committee address [1] 288165 0
Ethics committee country [1] 288165 0
Date submitted for ethics approval [1] 288165 0
24/10/2012
Approval date [1] 288165 0
Ethics approval number [1] 288165 0

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 34804 0
Address 34804 0
Country 34804 0
Phone 34804 0
Fax 34804 0
Email 34804 0
Contact person for public queries
Name 18051 0
Lauren Speed
Address 18051 0
251 Mountain Highway Wantirna
Victoria 3152
Country 18051 0
Australia
Phone 18051 0
+61 3 99551291
Fax 18051 0
Email 18051 0
Lauren.Speed@easternhealth.org.au
Contact person for scientific queries
Name 8979 0
Lauren Speed
Address 8979 0
251 Mountain Highway Wantirna
Victoria 3152
Country 8979 0
Australia
Phone 8979 0
+61 3 99551291
Fax 8979 0
Email 8979 0
Lauren.Speed@easternhealth.org.au

No information has been provided regarding IPD availability
Summary results
No Results