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NCT05744245
Swallow Training With Biofeedback in Acute Post Stroke Dysphagia
Conditions: Dysphagia, Stroke
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 120
Sponsor: University of Nottingham
Summary
About 50% of people who have a stroke experience difficulty swallowing.
There is a growing evidence base showing that swallowing therapy can help to improve swallowing, but we don't know which type or how much therapy is most beneficial.
The investigators are further developing one particular intervention - swallow strength and skill training with biofeedback.
This involves practicing strong or effortful swallows and practicing controlling the timing of swallowing using visual feedback on a screen showing the activity of the muscles involved in swallowing.
The investigators want to know whether trained clinicians are able to deliver this therapy in acute hospital settings early after stroke.
The investigators also want to explore whether there is an effect of dose in improving swallowing and other health factors.
To do this the investigators will conduct a trial across several stroke units in the east midlands.
The study aims to recruit 120 participants who have had a stroke and have dysphagia and who will randomly be placed in one of three groups.
One group will get a standard dose therapy (10 x 35 minute sessions over 2 weeks), another group with receive a high dose therapy (20 x 35 minute sessions over 2 weeks) and the third will receive 'usual care' which is what they would usually get from their current service.
The investigators will look at what therapy participants actually get, what factors might influence this and the training, support and conditions that enable clinicians to deliver the therapy.
The investigators will also assess the participants swallowing and collect information on their health, face to face at the beginning and after the therapy and over the phone at three months.
Eligibility Criteria
Inclusion Criteria:Adults over 18Clinical diagnosis of stroke>1 week and < 8 weeks post strokeNew moderate to severe dysphagia (DSRS ≥4) with a score of at least 1 on the fluid sub-sectionNot rapidly improving dysphagia (2 clinical SLT assessments over a week showing minimal change in DSRS)Pass an eligibility screen - sufficient visual, cognitive and communication skills to participate in the interventionExclusion Criteria:Medically unwell, GCS <10, on >4L oxygen, poor prognosis, EOLCPrevious dysphagiaDegenerative neurological conditionSevere visual impairmentSevere cognitive & communication impairmentPatient likely to be repatriated to or rehabilitated at another organisation with 10 daysParticipation in another trial aimed at improving dysphagiaUnwilling to remove beard/hair from under chin
Source: ClinicalTrials.gov (NCT05744245). StuddyBuddy aggregates publicly available trial information.