NCT05744245Completed
Swallow Training with Biofeedback in Acute Post Stroke Dysphagia
Swallow Strength and Skill Training with Biofeedback in Acute Post Stroke Dysphagia
Source: ClinicalTrials.gov · Last updated 24 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 20 Dec 2022
- Start date
- 15 May 2023
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- University of Nottingham
- Diseases
- Stroke
- NCT number
- NCT05744245
What you commit to
- Study type: Interventional
- Participants enrolled: 34
- From 15 May 2023 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous dysphagia
Other illness
- Degenerative neurological condition
- Severe visual impairment
- Severe cognitive \& communication impairment
Other
- Medically unwell, GCS \<10, on \>4L oxygen, poor prognosis, EOLC
- Patient likely to be repatriated to or rehabilitated at another organisation with 10 days
- Participation in another trial aimed at improving dysphagia
- Unwilling to remove beard/hair from under chin
Who the study is looking for
- Adults over 18
- Clinical diagnosis of stroke
- \>1 week and \< 8 weeks post stroke
- New moderate to severe dysphagia (DSRS ≥4) with a score of at least 1 on the fluid sub-section
- Not 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 intervention
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Derby Coordinator of this site? Confirm its status | Derby | United Kingdom | Unknown status |
Related publications
- Swallow Strength and Skill Training with biofeedback In acute Post stroke dysphagia (ssSIP): a protocol for a multi-centre feasibility trial.Pilot Feasibility Stud · 2026 · PMID 41851810
This page is information, not medical advice. Discuss any trial with your doctor.