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Swallow Training With Biofeedback in Acute Post Stroke Dysphagia (ssSIP)

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ClinicalTrials.gov Identifier: NCT05744245
Recruitment Status : Not yet recruiting
First Posted : February 24, 2023
Last Update Posted : February 24, 2023
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

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.

Condition or disease Intervention/treatment Phase
Dysphagia Stroke Other: Swallow Strength and Skill Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Swallow Strength and Skill Training With Biofeedback in Acute Post Stroke Dysphagia
Estimated Study Start Date : March 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Standard dose

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
Practice swallowing exercises with biofeedback and strength and skill targets

Experimental: High dose

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
Practice swallowing exercises with biofeedback and strength and skill targets

No Intervention: Usual care
Usual care



Primary Outcome Measures :
  1. Feasibility in patients with acute post stroke dysphagia [ Time Frame: Throughout study completion, to be completed by December 2024 ]
    Number of participants recruited, dose of swallow therapy

  2. Feasibility of delivery by acute stroke NHS clinicians - the intervetion [ Time Frame: Through study completion, to be completed by December 2024 ]
    Percentage of core components of the intervention delivered (fidelity checklist from observations)

  3. Feasibility of delivery by acute stroke NHS clinicians - the training [ Time Frame: Through study completion, to be completed by December 2024 ]
    Usefulness of training and training materials (qualitative interviews)


Secondary Outcome Measures :
  1. Dysphagia Severity [ Time Frame: Day 15 ]
    Dysphagia Severity Rating Scale (Score 0-12, 12 being the worst score)

  2. Feeding Status [ Time Frame: Day 15 ]
    Feeding Status Scale (Score 1-7, 7 being the worst score)

  3. Swallow Strength and Skill [ Time Frame: Day 15 ]
    % increase in swallow effort and % of successful timing and amplitude swallows

  4. Pnuemonia [ Time Frame: Day 90 ]
    Percent of participants with pneumonia

  5. Feasibility of cost effectiveness methods [ Time Frame: Day 90 ]
    Completeness of health economic data collection


Other Outcome Measures:
  1. Swallow safety and efficiency (subsection of participants) [ Time Frame: Day 15 ]
    ASPEKT-C



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05744245


Contacts
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Contact: Jacqueline Benfield, PhD 07738017966 jacqueline.benfield1@nottingham.ac.uk

Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Jacqueline Benfield, PhD University of Nottingham
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT05744245    
Other Study ID Numbers: 22043
First Posted: February 24, 2023    Key Record Dates
Last Update Posted: February 24, 2023
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Nottingham:
Biofeedback
Rehabilitation
Surface Electromyography
Additional relevant MeSH terms:
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Deglutition Disorders
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases