App-based Swallowing Skill Rehabilitation after Stroke

INTERVENTION: 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 si Xmonths 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 bo Xthat appears on the screen. The app will provide visual and audio feedback regarding the participants task performance. Furthermore, the app will auto CONDITION: Physical Medicine / Rehabilitation ‐ Speech therapy Stroke ‐ Haemorrhagic Stroke ‐ Ischaemic stroke;dysphagia;swallowing impairment; ; stroke ; dysphagia ; swallowing impairment PRIMARY OUTCOME: Fluid ingestion efficiency as measured by ‘swallowing capacity(mL/swallow)’ via Timed Water Swallowing Test (TWST) (Hagglund et al.., 2022).[ ‐initial study enrolment(baseline); ‐acute hospital discharge ; ‐inpatient rehabilitation discharge ; ‐6 months post initial study enrolment ] Solid ingestion efficiency as measured by ‘ingestion time (seconds)’ via Test of Masticating and Swallowing Solids (ToMaSS) (Huckabee & Lamvik‐Gozdzikowska, 2018)[ ‐initial study enrolment (baseline); ‐acute hospital discharge ; ‐inpatient rehabilitation discharge ; ‐6 months post initial study enrolment. ; ] Yes/No binary outcome regarding participants return to preadmission diet measured by the Functional Oral Intake Scale (FOIS) (Crary et al., 2005)[ ‐initial study enrolment (baseline); ‐every 5 days during acute hospital and inpatient rehabilitation ; ‐every 10 days in the community immediately after hospital discharge for two months ; ‐thereafter, every 20 days in the community for up to 6 months ; ] SECONDARY OUTCOME: Amount of caregiver time assisting participants in the community. The outcome will be collected via caregivers’ written report (#minutes).[ ‐initial study enrolment (Baseline), ; ‐every 5 days in the acute hospital and inpatient‐rehabilitation hospital, ; ‐every 10 days in the community post hospital discharge for 2 months, ; ‐thereafter every 20 days in community up to a maximum of 6 months.] Amount of caregiver time assisting participants in the hospital. The outcome will be collected via caregivers’ written report (#minutes).[ ‐initial study enrolment (Baseline), ; ‐every 5 days in the acute hospital and inpatient‐rehabilitation hospital, ; ‐every 10 days in the community post hospital discharge for 2 months, ; ‐thereafter every 20 days in community up to a maximum of 6 months.] Amount of healthcare worker time (other than Speech‐Language Pathologist) when managing participant during hospital stay. The outcome will be collected via medical chart review (#minutes).[ ‐initial study enrolment (Baseline), ; ‐every 5 days in the acute hospital and inpatient‐rehabilitation hospital, ; ‐every 10 days in the community post hospital discharge for 2 months, ; ‐thereafter every 20 days in community up to a maximum of 6 months.] Amount of healthcare worker time (other than Speech‐Language Pathologist) when managing participant in the community. The outcome will be collected via medical chart review /participants’ report (#minutes).[ ‐initial study enrolment (Baseline), ; ‐every 5 days in the acute hospital and inpatient‐rehabilitation hospital, ; ‐every 10 days in the community post hospital discharge for 2 months, ; ‐thereafter every 20 days in community up to a maximum of 6 months.] Amount of speech‐language pathologist time for instrumental swallowing assessment during Fiberoptic Endoscopic Evaluation of Swallowing (FEES). The outcome will be collected via medical chart review (#minutes)[ Assessed at the conclusion of the study ; ] Amount of speech‐language pathologist time for instrumental swallowing assessment during Videofluoroscopic Swallowing Study (VFSS). The outcome will be collected via medical chart review (#minutes)[ Assessed at the conclusion of the study ; ] Clinician time (Christchurch Hospital /Burwood Hospital /community speech‐language pathologist) (#minutes) as written in the clinician medical notes.[ ‐initial study enrolment (Baseline), ; ‐every 5 days in the acute hospital and inpatient‐rehabilitation hospital, ; ‐every 10 days in the community post hospital discharge for 2 months, ; ‐thereafter every 20 days in community up to a maximum of 6 months. ; ] Cost of Chest X‐ray will be estimated from Pharmac Medical Device List (Source: https://pharmac.govt.nz/hospital‐devices/devices‐list/).[ Assessed at the conclusion of the study.] Cost of drugs for Nasogastric Tube or Percutaneous Endoscopic Gastrostomy tube insertion per participant, estimated from Pharmaceutical Collection or participant self‐report in the community. (Source: Ministry of Health New Zealand).[ Assessed at the conclusion of the study ; ] Cost of equipment for Nasogastric Tube or Percutaneous Endoscopic Gastrostomy tube insertion per participant, estimated from Pharmac Medical Device List or participant self‐report in the community. (Source: https://pharmac.govt.nz/hospital‐devices/devices‐list/).[ Assessed at the conclusion of the study ; ] Cost of x‐rays for Nasogastric Tube or Percutaneous Endoscopic Gastrostomy tube insertion per participant, estimated from Pharmac Medical Device List or participant self‐report in the community. (Source: https://pharmac.govt.nz/hospital‐devices/devices‐list/).[ Assessed at the conclusion of the study ; ] Diet level, as measured by 8‐level International Dysphagia Diet Standardization Initiative (IDDSI) framework (Steele et al., 2018)[ ‐initial study enrolment (Baseline), ; ‐every 5 days in the acute hospital and inpatient‐rehabilitation hospital, ; ‐every 10 days in the community post hospital discharge for 2 months, ; ‐thereafter every 20 days in community up to a maximum of 6 months. ; ] Duration of non‐oral feeding (# days) using Nasogastric Tube/ Percutaneous Endoscopic Gastrostomy Tube, collected via medical chart review / participant's report[ Assessed at the conclusion of the study] Health‐Related Quality of Life measured using the EuroQoL 5 dimension 5 levels (EQ‐5D‐5L)(Golicki et al., 2015)[ ‐initial study enrolment (baseline) ; ‐acute hospital discharge ; ‐inpatient rehabilitation discharge ; ‐6 months post initial study enrolment. ] Healthcare professionals time (Other than speech‐language pathologist) involved in Fiberoptic Endoscopic Evaluation of Swallowing). The outcome will be collected via medical chart review (#minutes).[ Assessed at the conclusion of the study ; ] Healthcare professionals' time (other than speech‐language pathologist) involved in Videofluoroscopic Swallowing Study (VFSS). The outcome will be collected via medical chart review (#minutes).[ Assessed at the conclusion of the study ; ] Hospital event cost weight per participant as estimated from the National Minimum Dataset. (Source: Ministry of Health New Zealand).[ Assessed at the conclusion of the study.] Number of days in acute hospital care [Christchurch Hospital] as collected via National Minimum Dataset / participants’ report in the community.[ Assessed at the conclusion of the study.] Number of swallows produced at rest (Spontaneous Swallowing Frequency [SSF]) (Crary et al.,2013) ‐ Primary Outcome 4[ ‐initial study enrolment(baseline) ; ‐acute hospital discharge ; ‐inpatient rehabilitation discharge ; ‐6 months post initial study enrolment ] Number of times transferred to higher‐level hospital care (e.g., Christchurch Hospital) from different settings (e.g., Burwood hospital, home/ community settings) as collected via medical chart review / National Minimum Dataset / InterRAI Collection /participants’ report in the community. (Source: Ministry of Health New Zealand).[ Assessed at the conclusion of the study. ; ] Participants’ lived experience of using intensive, app‐based swallowing skill training explored via phenomenological semi‐structured interviews.[ ‐hospital discharge (Christchurch / Burwood Hospital) ; ‐6 months post initial study enrolment.] Presence of aspiration pneumonia as written in medical chart / participants self‐report. ; ; The diagnosis of aspiration pneumonia will be determined by medical team following the definition by Mann et al. (1999). Three or more criteria will result in a diagnosis of pneumonia: fever (>38°C), productive cough with purulent sputum, abnormal respiratory examination (tachypnea [>22/min], tachycardia, inspiratory crackles, bronchial breathing), abnormal chest radiograph, arterial hypoxemia (PO2 <70 mm Hg), and isolation of a relevant pathogen (positive gram stain and culture).[ Assessed at the conclusion of the study.] Presence of non‐oral feeding (Nasogastric Tube/ Percutaneous Endoscopic Gastrostomy Tube) collected via medical chart review / participants’ report[ Assessed at the conclusion of the study] Quantity of bed days in hospital (general ward and ICU) collected from National Minimum Dataset. (Source: Ministry of Health New Zealand).[ Assessed at the conclusion of the study. ; ] Quantity of chest x‐ray per participant via medical chart review. [ Assessed at the conclusion of the study ; ] Quantity of instrumental swallowing evaluation using Fiberoptic Endoscopic Evaluation of Swallowing (FEES) collected via medical chart review. [ Assessed at the conclusion of the study ; ] Quantity of instrumental swallowing evaluation using Videofluoroscopic Swallowing Study (VFSS) collected via medical chart review.[ Assessed at the conclusion of the study ; ] Quantity of Nasogastric Tube or Percutaneous Endoscopic Gastrostomy tube insertion per participant as collected from medical chart review / participants’ report in the community [ Assessed at the conclusion of the study] Rating of stroke disability as measured by Modified Rankin Scale (mRS) [ ‐initial study enrolment (baseline) ; ‐inpatient rehabilitation discharge ; ‐6 months post initial study enrolment ] Researcher time when delivering intervention (accumulation of the time spent on assessment, support, and adjusting treatment dosage) (# minutes) as written in the researcher notes.[ ‐initial study enrolment (Baseline), ; ‐every 5 days in the acute hospital and inpatient‐rehabilitation hospital, ; ‐every 10 days in the community post hospital discharge for 2 months, ; ‐thereafter every 20 days in community up to a maximum of 6 months. ; ] Swallowing‐related quality of care as measured by SWAL‐CARE (McHorney et al., 2002). [ ‐initial study enrolment (baseline) ; ‐inpatient rehabilitation discharge ; ‐6 months post initial study enrolment] Swallowing‐related quality of life measured using the SWAL‐QOL (McHorney et al., 2002) [ ‐initial study enrolment (baseline) ; ‐inpatient rehabilitation discharge ; ‐6 months post initial study enrolment] The mHealth App Usability Questionnaire for Interactive mHealth Apps (Patient Version) (Zhou et al., 2019). [ ‐initial study enrolment (baseline) ; ‐inpatient rehabilitation discharge ; ‐6 months post initial study enrolment] Total cost of medications per participant estimated by Pharmaceutical Collection. (Source: Ministry of Health New Zealand).[ Assessed at the conclusion of the study..] Total cost of nutritional supplements estimated from the Pharmaceutical Collection., (Source: Ministry of Healthy New Zealand).[ Assessed at the conclusion of the study.] 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)