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NCT05744245: ssSIP

Swallow Training with Biofeedback in Acute Post Stroke Dysphagia

Completed NA Last updated 24 March 2025
What this trial tests

NA trial testing Swallow Strength and Skill Training in Dysphagia in 34 participants. Completed in 31 December 2024.

Timeline
15 May 2023
Primary endpoint
31 December 2024
31 December 2024

Quick facts

Lead sponsorUniversity of Nottingham
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment34
Start date15 May 2023
Primary completion31 December 2024
Estimated completion31 December 2024
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

University of Nottingham

Who can join

18 and older, any sex, with Dysphagia or Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Swallow Strength and Skill Training with biofeedback In acute Post stroke dysphagia (ssSIP): a protocol for a multi-centre feasibility trial.
    Benfield JK, Woods K, Woodhouse L, Roadevin C, et al · · 2026 · PMID 41851810 · DOI 10.1186/s40814-026-01803-z
  2. Swallow Strength and Skill Training with Biofeedback in Acute Post Stroke Dysphagia (ssSIP): Protocol paper.
    Benfield JK, Woods K, Woodhouse L, Roadevin C, et al · · 2024 · DOI 10.21203/rs.3.rs-5136080/v1

Verify or expand the search:

Other recruiting trials for Dysphagia

Currently open trials in the same condition.

Other University of Nottingham trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05744245.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing