None listed
Conditions
Brief summary
Dysphagia (difficulty swallowing) is common following stroke and can compromise nutritional, hydration and respiratory status, as well as be associated with increased mortality, poor functional outcomes, decreased quality of life and increased burden on patients and caregivers. However, as the knowledge of the mechanisms underlying this presentation and evolution remains poor, patients are generally provided with untailored, and unspecific strengthening exercises regardless of their physiologic needs, and may not always receive the specific rehabilitation for swallowing that is necessary for recovery. The purpose of this study is to investigate the effectiveness of swallowing rehabilitation targeting the strength or skill deficit underlying dysphagia. Patients at six months post stroke with persisting dysphagia will undergo one-hour daily treatment for two weeks involving a swallowing strength or skill training protocol depending on their presenting deficit. Data on their swallowing and quality of life will be collected during two pre- and two post-treatment sessions, conducted two weeks apart. Additionally, a third post-treatment data collection session will be carried out two months later when available.
Interventions
Brief name: Impairment-based rehabilitation of dysphagia post stroke
Procedure:
* This study is an exploratory within subject, interventional A-B-A study design where, participants will be their own control.\
Participants will undergo 2 pre- and 2 post-treatment data collection sessions, all conducted 2 weeks apart. An initial 2-week ‘no-treatment’ period will enable the assessment of stability of measurement and task performance; a 2-week post-treatment period will enable the assessment of ski
Brief name: Impairment-based rehabilitation of dysphagia post stroke Procedure: * This study is an exploratory within subject, interventional A-B-A study design where, participants will be their own control.\ Participants will undergo 2 pre- and 2 post-treatment data collection sessions, all conducted 2 weeks apart. An initial 2-week ‘no-treatment’ period will enable the assessment of stability of measurement and task performance; a 2-week post-treatment period will enable the assessment of skill retention. When participants are available, an additional post-treatment data collection session will be carried out 2 months later in order to measure the longer-term retention of the effects. * Intervention procedures will take place either at home or at an outpatient specialised University clinical research facility or at participants’ home. Participants will undergo a 2-week individual, face-to-face, intensive swallowing rehabilitation programme (1 hour session, 5 days per week, for a total amount of 10 sessions across 2 weeks, with attendance checklist to monitor adherence to the intervention). Participants will be allocated into two intervention groups at baseline, depending upon their dysphagia presentation, i.e presence of a strength or a precision (“skill”) deficit as identified using the method described by Ng et al. (2020). Participants with an identified strength impairment will undergo a strength-based training involving 100 effortful swallows across 1 hour; whereas participants identified with impairment of swallowing skill will undergo a skill-based training involving 100 skilled (timely and accurate) swallows across 1 hour. Material: Biofeedback for Strength and Skill Training™ (BiSSkiT™) software and treatment protocol, paired with NeuroTrac Simplex™ surface electromyography (sEMG) biofeedback device, with electrodes placed underneath the chin in order to capture the activity of the submental swallowing muscles. This will be used during the treatment sessions : participants will have to swallow and control their swallow (timing, amplitude) using biofeedback. - Intervention and evaluation will be delivered by a fully qualified Speech-language Therapist (SLT) with over 15 years expertise in the treatment and rehabilitation of dysphagia. Randomisation and blinding of outcome measures will be used, with inter- and intra-rater reliability measured on 20% of the data sample.
Sponsors
Prof Maggie-Lee Huckabee
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet all of the inclusion criteria below to participate in this study: - completion of the preliminary observational, prospective study (STUDY ONE) aiming at characterising dysphagia based on its underlying strength and skill deficits, with the presence of any pathological indicator from clinical exam AND presence of a strength or skill component underlying dysphagia as documented at completion of this first study - able to participate in the treatment study (duration and location) - able to provide informed written consent and to participate in an intensive rehabilitation programme. Additionally, as this study involves applying an adhesive electrode patch under the chin, participants will be required to consent to shaving this area at each time point and during the treatment study. An information sheet will be given to all eligible participants. Written informed consent for inclusion in the study and data collection will be obtained after full verbal explanation regarding the study aims and protocol.
Exclusion criteria
Participants meeting any of the exclusion criteria at baseline will not be included in the study: - co-existing serious condition affecting swallowing and/or cognition (e.g. Head and neck cancer, Parkinson’s disease, Huntington’s disease, motor neuron disease, or major neurocognitive disorder) - participants with current intubation or tracheostomy as it can affect swallowing - unwillingness to provide written informed consent (participant, family / EPOA) - any new stroke event occurring during the study period will result in termination of study involvement - current involvement in rehabilitation of swallowing with another therapist
Outcome results
None listed