None listed
Conditions
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
Interventions
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 el
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).
Sponsors
Jennifer Paraskeva
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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)
Outcome results
None listed