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ssSIP trial

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Swallow Strength and Skill training with biofeedback In Post-stroke dysphagia

For further information please contact us.
• Chief investigator
• Nottingham stroke trials office
Email:

To start recruitment and submit trial data, please log into REDCap.
https://stroke.nottingham.ac.uk/sssip/live/

Title

Swallow Strength and Skill training with biofeedback In Post-stroke dysphagia (ssSIP)

Acronym

ssSIP

Chief investigator

Dr Jacqueline Benfield

Objectives

To investigate the feasibility of delivering swallow strength and skill training (ST) by clinical teams in acute stroke NHS settings and explore which dose of the intervention results in the best treatment effect for dysphagia severity.

Trial configuration

Multicentre, prospective, assessor blinded, three-arm randomised controlled feasibility trial.

Setting

Secondary/tertiary care – inpatient acute stroke and rehabilitation hospitals

Sample size estimate

Sample size target will be 120, this will allow for a dropout rate of 10% and an estimated 4% who will fail the screening assessment to achieve 34 participants per group for final analyses.

Number of participants

Clinical trial participants: N=120
Process evaluation:
  • Therapy session observations with clinicians: N=6
  • Interviews with clinicians: N=12

Eligibility criteria

Inclusion: adults over 18, over 1 week and under 8 weeks post-clinical diagnosis of stroke, new stable moderate to severe dysphagia (DSRS ≥4 OR patients where the SLT has identified safety risks with full amounts thin Level 0 fluids and 2 clinical SLT assessment showing minimal change in DSRS), have passed a screening assessment- able to produce a volitional swallow, visually follow the trace of their movements on a screen and have the cognitive and communicative ability to follow the instructions of the intervention.
Exclusion: medically unwell, GCS <10, on >4L oxygen, poor prognosis, EOLC, previous dysphagia, degenerative neurological condition, patient likely to be repatriated to or rehabilitated at another organisation, participation in another trial aimed at improving dysphagia

Description of interventions

  • Standard dose ST: 1 x 35 minute session per day - 5 days per week, over 2 weeks (10 ST sessions in total) with usual care.
  • High dose ST: 2 x 35 minute sessions per day - 5 days per week, over 2 weeks (20 ST sessions in total) with usual care.
  • Usual care only.

Duration of study

  • From randomisation, study intervention 2 weeks, final follow up day 90
  • Planned recruitment: January 2023 – October 2024
  • Last data Day 90 collection at December 2024
  • Planned recruitment for the process evaluation interviews and observations –Jan 2024- December 2024

Randomisation and blinding

Randomisation through online database by minimisation for age, stroke severity, dysphagia severity and site.  Study intervention will be delivered by dedicated members of NHS staff.  Outcomes will be assessed by other NHS and research staff blinded to randomised treatment.

Statistical methods

Descriptive statistics will be reported for all quantitative outcomes.  Twoway analysis of DSRS, will compare between high and standard dose, high dose and control and standard and control using multiple linear regression with adjustment for minimisation variables.
Contact details
Address: Room S/D2108
Stroke Trials Unit
School of Medicine
University of Nottingham
Queen's Medical Centre
Derby Road
Nottingham NG7 2UH
United Kingdom

Tel: 0115 823 1782
Email:
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