Swallow Training with Biofeedback in Acute Post Stroke Dysphagia

NCT05744245 | Completed DMC

• 1 other identifier: 22043
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysphagia; Stroke

Keywords

Biofeedback; Rehabilitation; Surface Electromyography

Outcome Measures

Primary Outcomes (3)

• Feasibility in patients with acute post stroke dysphagia

  Number of participants recruited, dose of swallow therapy

  Throughout study completion, to be completed by December 2024

• Feasibility of delivery by acute stroke NHS clinicians - the intervetion

  Percentage of core components of the intervention delivered (fidelity checklist from observations)

  Through study completion, to be completed by December 2024

• Feasibility of delivery by acute stroke NHS clinicians - the training

  Usefulness of training and training materials (qualitative interviews)

  Through study completion, to be completed by December 2024

Secondary Outcomes (5)

• Dysphagia Severity

  Day 15

• Feeding Status

  Day 15

• Swallow Strength and Skill

  Day 15

• Pnuemonia

  Day 90

• Feasibility of cost effectiveness methods

  Day 90

Other Outcomes (1)

• Swallow safety and efficiency (subsection of participants)

  Day 15

Study Arms (3)

Standard dose

EXPERIMENTAL

1 x 35 minute therapy session of Swallow Strength and Skill training per day, 5 days a week for 2 weeks. 10 sessions in total. Plus usual care

Other: Swallow Strength and Skill Training

High dose

EXPERIMENTAL

2 x 35 minute therapy therapy sessions of Swallow Strength and Skill training, per day, 5 days a week for 2 weeks. 20 sessions in total. Plus usual care

Other: Swallow Strength and Skill Training

Usual care

NO INTERVENTION

Usual care

Interventions

Swallow Strength and Skill Training OTHER

Practice swallowing exercises with biofeedback and strength and skill targets

High dose; Standard dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Medically unwell, GCS \<10, on \>4L oxygen, poor prognosis, EOLC
• Previous dysphagia
• Degenerative neurological condition
• Severe visual impairment
• Severe cognitive \& communication impairment
• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Derby

Derby, United Kingdom

Location

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jacqueline Benfield, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: February 24, 2023
• Study Start: May 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 24, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)