Impact of wearable biofeedback for the rehabilitation and tele-rehabilitation of neurogenic dysphagia - PROJECT SUMMARY/ABSTRACT Oropharyngeal swallowing disorders (a.k.a. dysphagia) are among the most common and dangerous manifestations of many neurologic conditions. Critically, dysphagia in neurologic diseases (i.e., neurogenic dysphagia) is often associated with highly negative health and quality of life outcomes. Despite this, optimal management for neurogenic dysphagia has yet to be established. Behavioral treatments in the form of head/neck exercises appear promising in improving swallowing in small-scale studies but typically require the use of adjunctive biofeedback. Further, two significant clinical-research gaps remain: a) to date biofeedback as adjunct to swallow therapy has not been systematically examined in the context of neurogenic dysphagia, and b) current swallowing biofeedback devices are large and/or expensive and thus not widely available. Hence, despite its promise, biofeedback-facilitated dysphagia treatment remains underused and understudied, limiting access to important swallowing rehabilitation services with potentially detrimental effects. To address these gaps, we developed and validated a cost-effective wearable surface electromyography (sEMG) biofeedback sensor technology (i-Phagia), optimized to record muscle activity from the head/neck and provide biofeedback to patients and adherence data to clinicians. In this proposal the objective is to conduct a large-scale randomized clinical trial (RCT) to determine the efficacy of sEMG biofeedback (using i-Phagia) as adjunct to a standardized swallow therapy protocol delivered both in-person and via telehealth compared to a standard of care (SOC) approach on swallow outcomes in patients with chronic stroke or Parkinson’s disease (PD), i.e., two common neurogenic dysphagia populations. Our long-term goal is to improve neurogenic dysphagia management through the development of evidence-based and accessible treatments. The aims of this study are to: 1) compare the safety, satisfaction, and efficacy of sEMG biofeedback as adjunct to in-person swallow treatment and a standard- of-care approach in improving swallow outcomes for patients with chronic stroke or PD and dysphagia; 2) compare the safety, satisfaction, and efficacy of sEMG biofeedback as adjunct to in-person vs. telehealth swallow treatment in improving swallow outcomes for patients with chronic stroke or PD and dysphagia, and 3) examine the role of clinical data (such as diagnosis, disease severity, age, stimulability, and neuromuscular activity at baseline) on treatment responsiveness. We will achieve the aims by conducting an RCT of 180 people with stroke or PD and dysphagia randomly assigned to one of three treatment groups (in-person i-Phagia, remote i-Phagia, and SOC). Upon study completion, we will have established the efficacy of sEMG biofeedback- facilitated swallow therapy for both in-person and telehealth service delivery in two neurogenic dysphagia populations, and we will have started to identify variables determining response to treatment. Our findings will have high potential to fill a critical gap in the rehabilitation of millions of patients with neurogenic dysphagia, while informing future work on larger effectiveness trials and tele-rehabilitation of this debilitating condition.
