Extrait

Background and study aims Yearly rates for stroke in England and Wales exceed 130,000. Of these, 37-78% will experience swallowing problems leading to complications including dehydration, malnutrition, choking, pneumonia and death. It also costs the NHS e.g. tube feeding and medication costs for complications resulting from swallowing difficulties. One of the most common swallowing problems is lifting of the voice box. Previous research on the effectiveness of electrical stimulation in treating swallowing problems has produced mixed results and so there has been a call for further research in order to try and clarify this issue. This study aims to help clarify whether this new treatment is more effective than currently available treatments at improving swallowing after stroke. Who can participate? People experiencing swallowing difficulties for at least one month following their stroke are eligible to participate in this study. What does the study involve? This study will find out how well the AMPCARE programme works (which combines electrical stimulation with exercises), in improving laryngeal (voice box) elevation and swallowing. Usual care will be used as the comparator (control). Patients will be randomly allocated to either the treatment or control group. The treatment group will receive the AMPCARE Effective Swallowing Programme, with treatment sessions for 30 minutes per day, 5 days per week, for 4 weeks. The control group will receive usual care from Speech & Language Therapists (SLT). Usual care normally involves patient education, dietary modifications (e.g. thickened fluids, pureed diet), adapted head postures and exercise programmes for lip, tongue and throat muscles. Patients can choose to receive treatment in an outpatient setting, or their own home. Other assessments will be completed before and after treatment to measure how well the treatment has worked. Patients will also be asked to complete a questionnaire about acceptability of the programme and impact on their quality of life, and will be contacted by phone after 4 weeks to gather data on longer term treatment effects. What are the possible benefits and risks of participating? The potential benefits to patients are improved ability to eat and drink safely as a result of improved swallowing. No significant risks have been identified. Where is the study run from? The main study site is Sheffield NHS Teaching Hospitals Foundation Trust, UK. The study is in the process of opening recruitment to other local sites. When is study starting and how long is it expected to run for? June 2013 to March 2014 Who is funding the study? Funding has been secured from AMPCARE LLC, South Yorkshire CLAHRC (Collaboration for Leadership in Applied Health Research & Care) and Devices for Dignity, UK. Who is the main contact? 1. Dr Sue Pownall ([email protected]) 2. Lise Teasdale ([email protected])

Critère d'inclusion

• Topic: Stroke Research Network; Subtopic: Primary Care, Rehabilitation; Disease: Device used

Liens

• ictrp
• isrctn