Title: Development and dose optimisation of swallow strength and skill training with surface electromyographic biofeedback in acute stroke.
Funder: Health Education England

Abstract: BackgroundPost stroke dysphagia is common, it is an independent predictor of mortality, increases the risk of stroke associated pneumonia, malnutrition and dehydration and reduces quality of life. Research into to the treatment of post stroke dysphagia is increasing but to date trials are often small and of poor quality. There is an indication from the latest Cochrane review that behavioural intervention in the form of swallowing exercise improves dysphagia, reduces pneumonia and length of hospital stay. Little is known about which exercises are the most clinically and cost effective or what dose is optimal. One intervention, swallow strength and skill training, has theoretical underpinnings in exercise science and motor learning and is often paired with surface electromyographic (sEMG) biofeedback. In small observational studies this intervention has resulted in improvements in swallowing in chronic post stroke dysphagia. Delivering this intervention in an acute setting, when neuroplasticity is optimal might be more beneficial in improving post stroke dysphagia. Stroke survivors and their carers welcome research into improving dysphagia early to avoid adaptations such as tube feeding and thickened fluids. A recent study found the intervention to be feasible, safe and acceptable to patients in acute stroke. Several facilitators and barriers were identified in delivering the intervention that could impact on implementation in wider acute stroke services.Aims and objectives1. To refine the swallow strength and skill training2. To develop the approach and materials used to support staff to deliver the intervention optimally and investigate how this is implemented in different acute stroke units. 3. To find out what dose of swallow strength and skill training with sEMG biofeedback is the most clinically and cost effective? MethodsPart 1: Engagement with a PPI group and using data from the feasibility study to refine the protocol, such as selecting the most user friendly biofeedback software and electrodes. Part 2: Engagement with a stakeholder group of speech and language therapists and assistants in a series of focus groups to develop the approach and training materials for implementation of the intervention.Part 3: 120 participants with dysphagia will be recruited into a clinical trial across 2-3 acute stroke units. They will be randomised to three groups and on top of usual care will receive different doses of the refined swallow strength and skill training intervention (no dose, standard dose or high dose). Primary outcome is number of participants with dysphagia at the end of the trial, secondary outcomes include swallowing and clinical measures. A process evaluation will be conducted to evaluate the implementation of the intervention and a cost consequence analysis will be carried out for each dose.Anticipated impact and disseminationBy carrying out this early refinement, exploring optimal dosing and cost effectiveness and identifying barriers and facilitators to implementation in different settings, this complex swallowing intervention is more likely to succeed in a larger multicentre trial investigating efficacy. Findings will be shared locally, nationally and internationally with researchers, clinicians, stroke survivors and their carers as well as the wider public.

Lay abstract: Aim: This work aims to find out if swallow therapy in the early stages after a stroke improves swallowing difficulties. Background: Around a 100,000 people have a stroke each year and around half of them have swallowing difficulties also known as dysphagia. If a person finds chewing and swallowing difficult, they may not eat and drink enough to keep them healthy. When dysphagia is more serious food or drinks can go down the wrong way. This can increase a person's chance of getting pneumonia and dying. Medical teams try to avoid these problems by keeping patients nil by mouth and inserting a tube to feed them or offering foods and drinks that are safer. These include softer or pureed food and drinks with a thickening powder. Eating and drinking are usually pleasurable occasions for most people so it's understandable that people with dysphagia say it impacts their quality of life. Research into dysphagia is a relatively new field. There are still a lot of unknowns such as what treatment is the most beneficial, who benefits, how much treatment is needed and how much will it cost the health service. One therapy called swallow strength and skill training aims to strengthen weakened swallowing muscles and improve control over swallowing. Feedback to patients about the timing and strength of muscle contractions (biofeedback) helps them perform these exercises. Surface electromyography measures the activity of swallowing muscles and can be used to give this biofeedback. Research has indicated that this therapy may help to improve swallowing in people six months after their stroke. In a recent study it was found that it was possible to offer this therapy early after stroke and it was safe. Patients reported it was comfortable and given at the right time after their stroke. Design and methods: This project aims to continue research into this therapy by completing three parts: The first part will take the results from the previous trial to improve the therapy. Other refinements will be made based on discussions with people who experienced swallowing difficulties after stroke and their carers. The second part will focus on developing and testing the approach and training materials for therapists who carry out the therapy in clinical settings to ensure that the therapy is delivered in the right way. The third part will be to carry out a clinical trial to compare different doses of therapy to find out which one improves dysphagia the most. The cost effectiveness of the different doses of therapy will also be calculated. Information will also be collected about how the therapists delivered the therapy and compared to the original plan. Long term goal: The findings of this research will be used to plan a larger study to test whether this therapy helps to improve dysphagia after stroke. Patient and public involvement: The Nottingham Stroke Research Partnership Group has been consulted and will continue to be consulted about this project. People who have experienced post stroke dysphagia will be invited to join a group to help improve the intervention, choose a way to measure its benefit and share the results. Healthcare professionals will help with designing the training materials. Dissemination: The research will be shared locally in the East Midlands, across the UK and around the world to patients and the public via public events, research talks, journals and research meetings. Outcome: By the end of this project, the swallow strength and skill therapy and training materials will be ready to be taken to a larger research trial investigating whether the therapy results in meaningful improvements in swallowing for people with post stroke dysphagia.

Research activity codes: 6.7 PHYSICAL
Health categories: STROKE