None listed
Conditions
Brief summary
Dysphagia (swallowing impairment) is common after stroke, and frequently associated with poor health and quality of life outcomes. This poses significant clinical and financial burden on the health-care system. Skill-based swallowing training is an emerging approach, with positive outcomes among patients with neurological disorders. Yet, this approach has not been explored in patients with post-stroke dysphagia (PSD) across the progression of their stroke journey. Furthermore, clinical applicability of skill-based training may be limited by various barriers in current health settings (e.g., large caseloads, limited resources, and poor access to medical services). Swallowing treatment delivered using mobile health applications may overcome these barriers. This study will longitudinally evaluate the effectiveness of intensive, app-based swallowing skill training in PSD, across hospital and community settings. Up to 60 participants presenting with new onset PSD at Christchurch Hospital will be recruited. Participants will be enrolled in this clinical trial up to a maximum period of 6 months. Participants will be allocated into two groups. The control group will receive usual dysphagia management (UDM) provided by the treating clinicians, whereas participants in the treatment group will similarly receive UDM with additional app-based swallowing skill-based training. The skill-based treatment will be delivered twice daily, 5 days per week. Researchers will remotely monitor and modify the treatment dosage, to reflect individuals’ performance across settings. Study Outcomes: Participants in both groups will be assessed at regular time intervals across the 6 months period. The outcome variables will be compared between baseline (T0) with three time points: discharge from acute hospital care (T1); discharge from inpatient rehabilitation setting (T2); and discharge from the study (T3). The primary outcomes include current dietary status and functional swallowing performance. Secondary outcomes include food and liquid consistency, presence and frequency of dysphagia-related complications and procedures, cost-benefit data, and quality of life measures. Medical chart will be reviewed to explore the biographical/demographical/medical status variables for input into the health economics analysis. Survey questionnaires will be administered to evaluate the usability and satisfaction towards this approach. Additionally, patient experience of using the swallowing skill-based app will be explored via semi-structured interviews. Hypothesis: Participants in the treatment group receiving intensive, app-based swallowing skill training will have greater improvement than the control group. This supports evidence suggesting that high-intensive treatment, provided during the critical period may augment the natural, heightened process of stroke recovery, ultimately promote adaptive neural plasticity and improve treatment outcomes, post-hospitalisation.
Interventions
This non-drug, randomized-controlled trial will longitudinally evaluate the effectiveness of intensive, app-based swallowing skill training in post-stroke dysphagia (PSD), across hospital and community settings. Participants will receive up to six months of treatment during the study and across settings (acute hospital [Christchurch Hospital], subacute hospital [Burwood Hospital], home/care facility with outpatient or community rehabilitation).
The experimental group will receive usual dysphagi
This non-drug, randomized-controlled trial will longitudinally evaluate the effectiveness of intensive, app-based swallowing skill training in post-stroke dysphagia (PSD), across hospital and community settings. Participants will receive up to six months of treatment during the study and across settings (acute hospital [Christchurch Hospital], subacute hospital [Burwood Hospital], home/care facility with outpatient or community rehabilitation). The experimental group will receive usual dysphagia management (UDM) and additional intensive, app-based swallowing skill training delivered via the Biofeedback in Strength and Skill App (BiSSkApp) technology. This includes a tablet with the downloaded BiSSkApp software, a portable sEMG with compatible charging port, and adhesive patches, all of which will be provided to participants at study enrolment. Participants will receive the trial intervention at the hospital or home/ community settings, where the treatment dosage will be individualized and modified/delivered by Principal Investigators to participants, remotely. The app-based swallowing skill treatment will require participants to place electrodes under the chin area to detect their submental muscle activity while swallowing. Participants may need to shave their chin to remove any facial hair so that the adhesive patch sticks to the skin. During swallowing, muscle activity will be displayed in the form of a time-by-amplitude waveform on the tablet screen. Participants will be instructed to control the timing and relative force of the muscles while swallowing, so that the peak of the waveform hits a target box that appears on the screen. The app will provide visual and audio feedback regarding the participants task performance. Furthermore, the app will automatically modify the task complexity by increasing or decreasing the target size by 10% following consecutive ‘hits’ or ‘misses’. Study intervention will be delivered by qualified speech-language therapists with certification in Good Clinical Practice. In addition, both Principal Investigators are experienced in supportive communication, treatment, and rehabilitation of swallowing disorder post-stroke. The skill-based intervention will be conducted between 10 minutes to one hour per session, twice per day, for five days per week. The treatment dosage will be set between 10 to 100 swallowing trials per session. The researchers will remotely monitor participants’ progress and modify treatment dosage based on the participants’ current level of swallowing functioning. Treatment dosage will be increased by 1 treatment block if participants adhere to the set dosage across two consecutive sessions in the hospital and a minimum of six sessions per week in the community. Principal investigators will support participants in the treatment group using BiSSkApp. Principal investigators will monitor and instruct participants remotely through BiSSkApp during rehabilitation sessions, and remotely monitor participants’ progress through a routine review schedule according to settings (e.g., monitor daily when participants stay in the hospital; weekly when participants enter the community).
Sponsors
University of Canterbury
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-adults aged 18 or over who have been hospitalized with acute stroke (any stroke type or lesion location). -presenting with new onset dysphagia, per hospital/health care system diagnostic procedure. -consent to shaving the submental surface area during study treatment/assessment to ensure adhesion of the electrode patch. -internet access at study location (e.g., hospital/ home setting/nursing residence)
Exclusion criteria
-presence of other neurological condition. -deemed legally blind. -presence of tracheostomy tube. -inability to provide informed consent with aphasia-friendly documents
Outcome results
None listed