Electrical muscle stimulation programme for swallowing post stroke V.1
Research type
Research Study
Full title
A single blind, randomised control (pilot) study comparing the efficacy of: 1) the AMPCARE Effective Swallowing Programme (electrical stimulation plus laryngeal elevation exercises) to: 2) usual care Speech and Language Therapy (SLT) dysphagia management for patients with stroke related dysphagia. (SLT usual care is defined in sections A6-1 and A13).
IRAS ID
123686
Contact name
Sue Pownall
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Research summary
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. There are also resource implications for the NHS e.g. tube feeding and medication costs for dysphagia related complications.
One of the most common swallowing problems is decreased laryngeal elevation (lifting of the voice box). Previous research on the efficacy of electrical stimulation in this area has produced mixed results.
SLT usual care involves patient education, dietary modifications (e.g. thickened fluids, pureed diet), adapted head postures and exercise programmes for lip, tongue and throat muscles.
This study will measure the efficacy of the AMPCARE programme, (which combines electrical stimulation with laryngeal exercises), in improving laryngeal elevation and swallow function. SLT usual care will be used as the comparator.
Patients will be eligible for the study if they have swallowing difficulties which include reduced laryngeal elevation as diagnosed by videofluoroscopy, (radiological procedure to assess swallowing). These difficulties should have persisted for at least one month post stroke (in order to exclude spontaneous recovery).
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. (Programme described in full in Section A13.) The control group will receive SLT usual care.
Patients can choose to receive treatment in an out-patient setting, or their own home.
Blinded clinical and radiographic assessments will be completed before and after treatment to measure treatment effect. Participants will also be asked to complete a questionnaire about acceptability of the intervention and impact on their quality of life, and will be contacted by phone after 4 weeks, to gather data on longer term treatment effects.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
13/YH/0100
Date of REC Opinion
22 May 2013
REC opinion
Further Information Favourable Opinion